Due Diligence of course...
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I finished my dd on HITR, I will be posting it shortly. I had no idea they did so much. Great Company imo. I wanted to get it done before I might possibly be admitted in the hospital again this week. Had test done on friday and they saw more masses. I will keep you posted my friend. I hope you have a great week
Cheer's
Diva
Wow, great news for HITR! executed as in dry ink executed? wahoooot!
just got home from the docs and messages in my inbox, yayyyyyyy
:)BIO updates Monday March 11, 2013
Aeterna Zentaris Inc. (NASDAQ: AEZS) announced an independent Data Safety Monitoring Board ("DSMB") has recommended discontinuing the ongoing Phase 3 study comparing the efficacy and safety of perifosine to placebo when combined with bortezomib (Velcade®) and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma. Based on the outcome of its pre-planned interim analysis of efficacy and safety, the DSMB recommended that patient enrollment be stopped and the study discontinued. The DSMB reported that it was highly unlikely the study would achieve a significant difference in its primary endpoint, progression free survival; no safety concerns were raised.
Juergen Engel, PhD, Aeterna Zentaris President and CEO stated, "We are obviously disappointed with the outcome of the interim analysis as reported to us by the DSMB, both from a patient and Company perspective. However, we remain focused on other significant opportunities such as our Phase 3 trial in endometrial cancer and Phase 2 trials in breast, prostate and bladder cancer with AEZS-108, our NDA filing for AEZS-130 as an oral diagnostic test for growth hormone deficiency in adults, as well as our earlier-stage oncology compound, AEZS-120."
ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, announced the initiation of a randomized, open label Phase 2 clinical study of Ad-RTS IL-12 in combination with palifosfamide to treat patients with non-resectable recurrent or metastatic breast cancer.
The two-part, multi-center U.S. study will enroll up to 68 patients with non-resectable, recurrent or metastatic breast cancer who have visible lesions or lesions accessible by injection. The study is designed to assess the safety and efficacy of the drug combination of Ad-RTS IL-12 and palifosfamide. Ad-RTS IL-12 is a targeted and controlled DNA-based therapeutic designed to express interleukin-12 (IL-12), a protein important for an immune response to cancer. Palifosfamide is a potent bi-functional DNA alkylating agent.
Part one of the two-part study will consist of a safety assessment for Ad-RTS IL-12 and palifosfamide, alone or in combination. Part two will consist of an efficacy evaluation of the Ad-RTS IL-12 only arm and the combination arm. The primary endpoint of the study is rate of progression-free survival at 16 weeks. Secondary endpoints include objective response rate, duration of response and evaluation of pharmacodynamic tumor markers.
"Several recent breakthroughs in cancer treatment are based on the hypothesis that the immune system plays a central role in suppressing both cancer's growth and metastasis," said John Nemunaitis, M.D., lead investigator and Executive Medical Director, Mary Crowley Medical Research Center. "For breast cancer, the positive correlation of survival with immune response in the tumor elicited by non-immune treatments has only recently been elucidated, and this understanding hints at the potential for exciting new breakthroughs in this still underserved population. We look forward to participating in this study and to gaining further insight regarding the combined effect of Ad-RTS IL-12, a selectively controlled immunotherapy, and palifosfamide, a potent bi-functional DNA alkylating agent."
Jonathan Lewis, M.D., Ph.D., Chief Executive Officer of ZIOPHARM, added, "This study has exciting potential, both for this difficult-to-treat indication and for our synthetic biology platform, in which Ad-RTS IL-12 is the lead program. Building on preclinical work supporting a synergistic effect between Ad-RTS IL-12 and palifosfamide, and the clinical findings from our ongoing Phase 2 melanoma study, we believe the combination of Ad-RTS IL-12 and palifosfamide has the potential to be quite impactful in breast cancer."
Abattis Bioceuticals Corp. (CNSX: FLU) (OTC: ATTBF), announces that it will not be proceeding with its $600,000 non-brokered private placement as previously announced in its Press Release dated February 12, 2013 as it is canvassing other avenues of financing through strategic relationships to prevent any dilution for its shareholders.
Abbott (NYSE: ABT) today announced positive long-term results for the company's innovative Absorb™ Bioresorbable Vascular Scaffold (BVS).
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that an independent Data Safety Monitoring Board ("DSMB") has recommended discontinuing the ongoing Phase 3 study comparing the efficacy and safety of perifosine to placebo when combined with bortezomib (Velcade®) and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma. Based on the outcome of its pre-planned interim analysis of efficacy and safety, the DSMB recommended that patient enrollment be stopped and the study discontinued.
Alimera Sciences, Inc. (NASDAQ: ALIM) ("Alimera"), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that it will release its fourth quarter and fiscal year 2012 financial results after the market close on Thursday, March 21, 2013.
AmbiCom Holdings, Inc. (OTCQB: ABHI), a leading designer and developer of wireless products for the medical and automotive industries, and a distributor of innovative healthcare products, today announced for the second quarter ending January 31, 2013, a reported revenue of $785,717 with net income of $154,322 or $0.015 per share.
BioElectronics Corporation (OTC Pink: BIEL), the maker of unique inexpensive, patented, anti-inflammatory pain reliever devices announced that the OTC Bulletin, the leading global trade publication for over-the-counter healthcare products has chosen its ActiPatch® Musculoskeletal Pain Relief Therapy as the first runner-up for the "Most Innovative New OTC Product."
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) and Astellas Pharma Inc. (Tokyo: 4503) today announced that they entered into an agreement under which Cubist obtains the rights to ceftolozane in certain Asia-Pacific and Middle East territories from Astellas.
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, announced the three-year results of a pivotal clinical study of severe aortic stenosis patients at high-risk for surgery.
GeoVax Labs, Inc. (OTCQB: GOVX), an Atlanta-based biotechnology company developing innovative, patented HIV/AIDS vaccines, today announced its financial results for the year ended December 31, 2012 and provided a business update.
Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) will be presenting at the 25th Annual ROTH Conference on March 18, 2013, at 3:00 p.m. PT (6:00 p.m. ET) in Laguna Nigel, CA.
Insmed Incorporated (NASDAQ: INSM), a biopharmaceutical company focused on developing and commercializing inhaled therapies for patients battling serious orphan lung diseases that are often life-threatening, today announced that the Company will release financial results for the three and twelve months ended December 31, 2012, before the opening of the stock market of Monday, March 18, 2013.
Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX), a biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease, today announced that a conference call will be held tomorrow, Tuesday, March 12, 2013 at 8:30 a.m. EDT to discuss the Company's fourth quarter and year-end 2012 financial results and provide a business outlook for 2013.
Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX), a biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease (the "Company"), today announced its results for the fourth quarter and year ended December 31, 2012.
Laboratory Corporation of America® Holdings (LabCorp®) (NYSE:LH) today announced that Adam H. Schechter, Executive Vice President and President, Global Human Health, Merck, has been appointed to its Board of Directors, effective April 1, 2013.
mPhase Technologies, Inc. (OTCBB: XDSL) announced today that it will be pursuing a broad array of government funding opportunities to collaborate with the U.S. Army for further development of its smart surface technology for products including reserve batteries and drug delivery systems and supercapacitors.
Micro Imaging Technology, Inc. (OTCQB: MMTC) announced that on March 7th the Travis County Texas District Court granted the Company's motion to dismiss a lawsuit filed by Alpine MIT Partners, LLC (Alpine) in May 2012.
Guy Sebastian, one of Australia's most well-known recording artists, today commented on a recent story in "The Australian" (www.mmrglobal.com/au) concerning the National E-Health Transition Authority (NEHTA), which has refused to respond to numerous requests from U.S. lawyers representing MMRGlobal, Inc. (OTCQB: MMRF) with regard to MMR's investigation of possible infringements of its Australian patents surrounding Personal Health Records ("PHRs").
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that Tim Coughlin, Chief Financial Officer of Neurocrine Biosciences, will be presenting at the 25th Annual Roth Conference in Laguna Niguel.
SurgiCount Medical, Inc., the wholly owned operating subsidiary of Patient Safety Technologies, Inc. (OTCBB:PSTX), today announced that Michael Roux has joined the Company in the position of Vice President of Product Management.
Rexahn Pharmaceuticals, Inc. (NYSE MKT: RNN), a clinical stage biopharmaceutical company focused on developing first in class therapies for the treatment of cancer, announced today that its new Chief Executive Officer Dr. Peter Suzdak and Chief Financial Officer Ted Jeong are scheduled to make an investor presentation at ROTH Capital Partners’ 25th Annual ROTH Conference on Wednesday, March 20, at 12:30 pm Pacific Time.
Sirona Biochem Corp. (TSX VENTURE:SBM) (OTCQX:SRBCF) (FRANKFURT:ZSB) announced today it has signed a material transfer agreement (MTA) with French-based VitamFero, a veterinary healthcare company. VitamFero, a member of Genopole®, will test Sirona Biochem's proprietary biological preservation technology with a goal to extend the storage time of its live attenuated animal vaccines.
SK3 Group, Inc. (OTC Pink: SKTO) today announces that it has acquired Medical Greens ™ and has changed its business model to focus purely in the medical marijuana space.
Tengion, Inc. (OTCQB: TNGN), a leader in regenerative medicine, today announced it will host a conference call and live audio webcast on Monday, March 18, 2013, at 9:00 a.m. EDT to provide a business update and discuss its fourth quarter and full year 2012 financial results.
VistaGen Therapeutics, Inc. (OTCQB: VSTA), a biotechnology company applying stem cell technology for drug rescue, predictive toxicology and drug metabolism assays, today announces it will feature key developments involving CardioSafe 3D™, its pluripotent stem cell-based bioassay system for heart toxicity, in a poster presentation at the Society of Toxicology's 52nd Annual Meeting, the world's premier toxicology conference, in San Antonio, Texas, on March 11, 2013, at 7:30 am PDT.
you trained me well on the art of organics. The kid bought me a ninja blender and it keeps me going!!! Everything is low fiber/low residue, no seeds, nothing with strings, no skins... etc etc. No wonder I hate food now, LOL if you can figure out how to peel a pea, let me know... ARE THEY KIDDING ME???
Hugz
Updating my progress...I have been getting floods of messages and I so appreciate everyone's kind words... present company included. Doing ok, just gonna take some healing time.
Hugz and love to all
diva
Home resting from surgery~Nice~ibox~UPDATE!!! your guys rock!
securing contracts?? in several regions including Poland, Egypt and Iraq? from the january news? Now I know I need to dd HITR
I love love love green company's:)
read the news from the other day, awesome stuff
I need to dd this comp beings I was in the autoparts industry for Delphi/GM :)
ty, #211 -cheer's :)
:) back into surgery on Thursday early AM... I am really getting sick of hospitals. Atleast since I am on liquids, I don't have to worry about yucky hospital food. Trying to stay positive... hugz to all
VVUS Receives Decision Regarding Qsiva Appeal
Press Release: VIVUS, Inc. – 3 hours ago
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Symbol Price Change
VVUS 12.88 -0.25
MOUNTAIN VIEW, Calif., Feb. 21, 2013 (GLOBE NEWSWIRE) -- VIVUS, Inc. (VVUS) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) confirmed its October 18, 2012 decision to decline the Marketing Authorization Application (MAA) for Qsiva(TM) (phentermine/topiramate ER) for the treatment of obesity in the European Union.
VIVUS had requested a re-examination of the opinion. After considering the grounds for this request, CHMP again declined the marketing authorization on February 21, 2013. In its consideration of the Qsiva MAA, CHMP indicated that a pre-approval cardiovascular outcomes trial would be necessary to establish long-term safety.
"We are disappointed with the CHMP decision regarding Qsiva and the position the Committee adopted with respect to the need for a preapproval cardiovascular outcomes trial," said Peter Y. Tam, president of VIVUS. "We have worked diligently throughout Europe with key opinion leaders and regulatory and risk management experts to highlight the favorable safety and efficacy profile of Qsiva. Despite the positive recommendation of CHMP's own Scientific Advisory Group (SAG) and the high unmet medical need in obese patients, a majority of CHMP members have failed to recognize the importance of making this treatment option available, particularly for patients whose only effective intervention is surgery."
Qsiva was approved by the U.S. FDA in July 2012 and is sold under the trade name Qsymia(TM). The pivotal Phase 3 clinical trial program included over 4,500 subjects studied up to two years, establishing Qsymia as a safe and effective treatment for obesity.
About Qsymia
Qsymia is approved in the U.S. and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol.
The effect of Qsymia on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established.
For more information, visit: www.qsymia.com.
Important Safety Information
Qsymia (phentermine and topiramate extended-release) capsules CIV is contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors (MAOIs); or in patients with hypersensitivity to sympathomimetic amines, topiramate, or any of the inactive ingredients in Qsymia.
Qsymia can cause fetal harm. Females of reproductive potential should have a negative pregnancy test before treatment and monthly thereafter and use effective contraception consistently during Qsymia therapy. If a patient becomes pregnant while taking Qsymia, treatment should be discontinued immediately, and the patient should be informed of the potential hazard to the fetus.
The most commonly observed side effects in controlled clinical studies, 5% or greater and at least 1.5 times placebo, include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth.
About VIVUS
VIVUS is a biopharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity, sleep apnea, diabetes and sexual health for U.S., Europe and other world markets. Qsymia is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. For more information about the company, please visit www.vivus.com.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate," "expect," "intend," "likely," "may," "plan," "potential," "predict," "opportunity" and "should," among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, our limited commercial experience with Qsymia in the U.S.; the timing of initiation and completion of the clinical studies required as part of the approval of Qsymia by the United States Food and Drug Administration, or FDA; the response from the FDA to the data that VIVUS will submit relating to post-approval clinical studies; the impact of the indicated uses and contraindications contained in the Qsymia label and the REMS requirements; the impact of distribution of Qsymia through a certified pharmacy network; whether or not the FDA approves our amendment to the REMS for Qsymia, which, if approved, would allow dispensing through select retail pharmacies to increase access while meeting all requirements of the REMS; that we may be required to provide further analysis of previously submitted clinical trial data; the negative opinion of the European Medicines Agency's, or EMA, Committee for Medicinal Products for Human Use, or CHMP, for the Marketing Authorization Application, or MAA, for Qsymia; our ability to successfully commercialize or establish a marketing partnership for avanafil, which will be marketed in the U.S. under the name STENDRA(TM); the ability of our partners to maintain regulatory approval to manufacture and adequately supply our products to meet demand; our history of losses and variable quarterly results; substantial competition; risks related to the failure to protect our intellectual property and litigation in which we may become involved; uncertainties of government or third-party payor reimbursement; our reliance on sole source suppliers; our limited sales and marketing and manufacturing experience; our reliance on third parties and our collaborative partners; our failure to continue to develop innovative investigational drug candidates and drugs; risks related to the failure to obtain FDA or foreign authority clearances or approvals and noncompliance with FDA or foreign authority regulations; our ability to demonstrate through clinical testing the safety and effectiveness of our investigational drug candidates; the timing of initiation and completion of clinical trials and submissions to foreign authorities; the results of post-marketing studies are not favorable; compliance with post-marketing regulatory standards is not maintained; the volatility and liquidity of the financial markets; our liquidity and capital resources; and our expected future revenues, operations and expenditures. As with any pharmaceutical in development, there are significant risks in the development, the regulatory approval, and the commercialization of new products. There are no guarantees that the product will receive regulatory approval outside the United States for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statements. Investors should read the risk factors set forth in VIVUS's Form 10-K for the year ending December 31, 2011, and periodic reports filed with the Securities and Exchange Commission.
Contact:
VIVUS, Inc.
Timothy E. Morris
Chief Financial Officer
morris@vivus.com
Investor Relations:
The Trout Group
Todd James
tjames@troutgroup.com
646-378-2926
Diva's BIO updates Tuesday February 19, 2013
Gilead Sciences (Nasdaq: GILD) announced topline results from the Phase 3 FUSION study evaluating 12- and 16-week courses of therapy with the once-daily nucleotide sofosbuvir plus ribavirin (RBV) in treatment-experienced patients with genotype 2 or 3 chronic hepatitis C virus (HCV) infection who failed prior treatment. The study met its primary efficacy endpoint of superiority compared to a predefined historic control sustained virologic response (SVR) rate of 25 percent. In FUSION, 50 percent of patients (n=50/100) in the 12-week arm and 73 percent of patients (n=69/95) in the 16-week arm achieved SVR12 (p<0.001 for both arms).
“This study demonstrates that all-oral therapy with sofosbuvir provides significant efficacy among difficult-to-treat hepatitis C patients who could not be cured by prior regimens containing pegylated interferon and now have limited treatment options,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer. “With positive results from all four Phase 3 trials now in hand, Gilead is on track to meet its goal of filing regulatory applications in the United States and Europe in the second quarter.”
In the FUSION study, HCV genotype 2 or 3 patients who failed prior interferon-based therapy were randomized (1:1) to receive either a 12-week (n=103) or 16-week (n=98) course of sofosbuvir 400 mg once daily plus RBV (1,000 or 1,200 mg/day). Sixty-three percent of patients were infected with genotype 3. In the 12-week arm, SVR12 rates were 86 percent among genotype 2 and 30 percent among genotype 3 patients. In the 16-week arm, SVR12 rates were 94 percent among genotype 2 and 62 percent among genotype 3 patients. Among the 34 percent of FUSION participants who had compensated cirrhosis at baseline, 31 percent achieved SVR12 in the 12-week arm, and 66 percent achieved SVR12 in the 16-week arm. All patients in the study became HCV negative on treatment, and relapse accounted for all virologic failures.
No patients discontinued sofosbuvir or RBV due to adverse events. The most common adverse events reported in =15 percent of patients in the study were fatigue, headache, insomnia and nausea.
Results from all four pivotal Phase 3 studies of sofosbuvir – FUSION, POSITRON, FISSION and NEUTRINO – will support the initial regulatory filing for sofosbuvir as part of all-oral therapy with RBV among genotype 2 and 3 treatment-naïve, treatment-experienced and interferon-intolerant HCV patients, and for sofosbuvir in combination with RBV and pegylated interferon among treatment-naïve patients with genotypes 1, 4, 5 and 6.
Perrigo Company (Nasdaq: PRGO) announced it has filed with the U.S. FDA an Abbreviated New Drug Application for testosterone gel 1.62% and that it has notified AbbVie Inc., the owner of the Reference Listed Drug of its filing.
On February 15, 2013, the Unimed Pharmaceuticals subsidiary of AbbVie and Besins Healthcare filed suit against Perrigo in the United States District Court for the District of Delaware, alleging patent infringement. This action formally initiates the process under the Hatch-Waxman Act. Perrigo believes that it is a first filer for this opportunity, entitling it to 180 days of generic exclusivity.
Androgel® 1.62% (testosterone gel 1.62%) is indicated to treat males who have low or no testosterone. Annual sales were approximately $680 million annually, as measured by Wolters Kluwer Health.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This filing is another example of our investment in new products and continued focus on bringing extended topicals to market. As always, Perrigo is committed to making quality healthcare more affordable for our customers and consumers."
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it will present at the RBC Capital Markets and the Citi 2013 Global Healthcare conferences in February.
Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that the Brown University Oncology Research Group (BrUOG) will be coordinating a Phase 1/2 study of ADXS-HPV in 25 patients with HPV-associated anal cancer.
AirWare Labs Corp. (OTCQB: AIRW) today shares the market outlook for its AIR® product lineup in context to products sold within the OTC (Over-the-Counter) and Natural/Homeopathic Marketplaces.
Align Technology, Inc. (NASDAQ: ALGN) announced today the launch of a new interactive web site that provides a broad range of professional education resources for Invisalign providers.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it will present at the RBC Capital Markets Healthcare Conference being held in New York City.
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced financial results for the fourth quarter and full year ended December 31, 2012.
BioMed Realty Trust, Inc. (NYSE: BMR) today announced the full exercise of the underwriters' option to purchase additional shares of common stock in connection with BioMed Realty's previously announced follow-on offering that priced on February 13, 2013.
Bruker Corporation (NASDAQ: BRKR) today reported financial results for its fourth quarter and full year ended December 31, 2012.
Capital Group Holdings, Inc. (OTCBB: CGHC) is pleased to announce it has received clearing from FINRA for its recently submitted 15c2-11 filing and its common stock is now quoted on the OTC Bulletin Board.
Capital Group Holdings, Inc. (OTCBB: CGHC) announced its consolidated results of operations for the quarter ending December 31, 2012.
China Cord Blood Corporation (NYSE: CO) (the "Company") today announced its plan to release financial results for the third quarter and first nine months of fiscal year 2013 on Tuesday, February 26, 2013, after market close in the US.
DARABiosciences (NASDAQ: DARA), a specialty pharmaceutical company focused on oncology and oncology supportive care products, is expecting to hear soon on the status of its Orphan Drug application submitted to The Food and Drug Administration (FDA) in November of last year for its drug KRN5500, which is being studied for the treatment of chronic chemotherapy-induced peripheral neuropathy (CCIPN).
DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM (NYSE, Euronext: DSM KON), announced today that it has signed a collaboration agreement with Chemtrix B.V., The Netherlands, in the field of Continuous Flow Chemistry.
Gilead Sciences (Nasdaq:GILD) today announced topline results from the Phase 3 FUSION study evaluating 12- and 16-week courses of therapy with the once-daily nucleotide sofosbuvir plus ribavirin (RBV) in treatment-experienced patients with genotype 2 or 3 chronic hepatitis C virus (HCV) infection who failed prior treatment.
GTx, Inc. (Nasdaq: GTXI) announced today that management will present a company overview on February 25, 2013 at the 2013 Citi Global Healthcare Conference in New York City. The GTx presentation will begin at 1.30 p.m. EST.
InSite Vision Incorporated (OTCBB: INSV) announced today that it will report financial results for the fourth quarter and year ended December 31, 2012 on Tuesday, March 5, 2013.
MediaTechnics Corporation (PINKSHEETS: MEDT) is pleased to announce that it executed an agreement to purchase a 51% interest in App Swarm Inc. ("ASI") in exchange for restricted preferred stock on February 11, 2012.
Mentor Capital, Inc. (Pink Sheets:MNTR) reports that its proprietary Cancer Immunotherapy Index declined (-10.9%) during 2012.
Morria Biopharmaceuticals Plc (OTCQB: MRRBY) (the "Company"), an emerging growth biopharmaceutical company focused on developing novel first-in-class, synthetic, multi-functional non-steroidal anti-inflammatory drugs, announced today that its American Depositary Shares ("ADSs") representing its ordinary shares have commenced trading on the OTC Bulletin Board in the United States under the ticker symbol MRRBY.
MMRGlobal, Inc. (OTCQB: MMRF) today announced that as a result of recent publicity, it has been brought to the Company's attention that vendors providing services to the Ministry of Health in Singapore appear to be infringing on patents (including Singapore patent number 200801954) and other Intellectual Property (collectively, the "MMR-IP") issued to MyMedicalRecords, Inc., a wholly owned subsidiary of MMRGlobal.
NanoViricides, Inc. (OTC: NNVC) (the "Company"), has filed its quarterly report with the Securities and Exchange Commission on Thursday, February 14th, in a timely fashion.
NeuroMetrix, Inc. (Nasdaq: NURO), a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, today reported business and financial highlights for the quarter and twelve months ended December 31, 2012.
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that Dr. Mark Pykett, President and Chief Executive Officer, will participate at the Citi 2013 Global Healthcare Conference on February 25-27, 2013 at the Hilton New York Hotel in New York City.
Oncolytics Biotech Inc.("Oncolytics") (TSX:ONC; NASDAQ: ONCY) announced today its intention, subject to market and other conditions, to commence an underwritten public offering of common shares.
Osiris Therapeutics, Inc. (NASDAQ: OSIR), the leading stem cell company developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets, announced today that the European Medicines Agency (EMA) has designated Osiris as the Orphan Drug title holder for Prochymal® (remestemcel-L).
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Bayer HealthCare today announced thatthey have initiated a new Phase 3 trial (named VIVID EAST-DME) to evaluate the efficacy and safety of EYLEA® (aflibercept) Injection in the treatment of Diabetic Macular Edema (DME) in Russia, China, and other Asian countries.
RXi Pharmaceuticals Corporation (OTC: RXII), a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using RNA-targeted technologies, today announced upcoming presentations at AsiaTIDES and at the ROTH 25th Annual Conference.
Santarus, Inc. (NASDAQ: SNTS) today announced that it will release fourth quarter 2012 financial results after market close on Monday, March 4, 2013.
Sobi (STO: SOBI) and Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) announced today that they have entered into an agreement for the co-promotion of Kineret® (anakinra) in the U.S.
ServiceSource® (NASDAQ: SREV), the global leader in recurring revenue management, today announced that it has expanded its partnership with GE Healthcare (NYSE: GE) to include Japan.
Teleflex Incorporated (NYSE: TFX) announced today the addition of the AutoFuser® disposable pain pump to its portfolio of Arrow® pain management products.
Today eHealth, Inc. (NASDAQ: EHTH) (eHealthInsurance.com), America's first and largest private online health insurance exchange, released a series of tips for health insurance consumers preparing to file their 2012 federal tax returns.
United Therapeutics Corporation (NASDAQ: UTHR) announced today that it will release its fourth quarter and annual 2012 financial results before market open on Tuesday, February 26, 2013.
VentriPoint Diagnostics (TSX VENTURE:VPT) (OTCQX:VPTDF) is providing a status report on its 2D echocardiographic (2DE) products, clinical research and regulatory submission plans.
Vermillion, Inc. (NASDAQ: VRML), a molecular diagnostics company focused on gynecologic cancers and vascular medicine, has been invited to participate in Lazard Capital Market's 5th Annual Medical Technology Snowbird Conference.
Vermillion, Inc. (NASDAQ: VRML), a molecular diagnostics company focused on gynecologic cancers and vascular medicine, will hold a conference call on Wednesday, February 20, 2013, at 4:30 p.m. ET to discuss full results for its fourth quarter and year ended December 31, 2012.
Verisante Technology, Inc. (TSX VENTURE:VRS) (OTCQX:VRSEF) (FRANKFURT:V3T) (the "Company" or "Verisante"), a leader in cancer detection technology, announced today that the Company has entered into an exclusive agreement with Pacifica Handels AG to distribute Verisante Aura™ in Switzerland.
WaferGen Bio-systems, Inc. (OTCBB: WGBS) announced today a co-marketing agreement with QIAGEN KK – a subsidiary of QIAGEN N.V.– for the joint promotion of certain products in Japan in the areas of genomics platforms such as Next-Gen sequencing (NGS) and qPCR.
BIO updates Tuesday February 19, 2013
Gilead Sciences (Nasdaq: GILD) announced topline results from the Phase 3 FUSION study evaluating 12- and 16-week courses of therapy with the once-daily nucleotide sofosbuvir plus ribavirin (RBV) in treatment-experienced patients with genotype 2 or 3 chronic hepatitis C virus (HCV) infection who failed prior treatment. The study met its primary efficacy endpoint of superiority compared to a predefined historic control sustained virologic response (SVR) rate of 25 percent. In FUSION, 50 percent of patients (n=50/100) in the 12-week arm and 73 percent of patients (n=69/95) in the 16-week arm achieved SVR12 (p<0.001 for both arms).
“This study demonstrates that all-oral therapy with sofosbuvir provides significant efficacy among difficult-to-treat hepatitis C patients who could not be cured by prior regimens containing pegylated interferon and now have limited treatment options,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer. “With positive results from all four Phase 3 trials now in hand, Gilead is on track to meet its goal of filing regulatory applications in the United States and Europe in the second quarter.”
In the FUSION study, HCV genotype 2 or 3 patients who failed prior interferon-based therapy were randomized (1:1) to receive either a 12-week (n=103) or 16-week (n=98) course of sofosbuvir 400 mg once daily plus RBV (1,000 or 1,200 mg/day). Sixty-three percent of patients were infected with genotype 3. In the 12-week arm, SVR12 rates were 86 percent among genotype 2 and 30 percent among genotype 3 patients. In the 16-week arm, SVR12 rates were 94 percent among genotype 2 and 62 percent among genotype 3 patients. Among the 34 percent of FUSION participants who had compensated cirrhosis at baseline, 31 percent achieved SVR12 in the 12-week arm, and 66 percent achieved SVR12 in the 16-week arm. All patients in the study became HCV negative on treatment, and relapse accounted for all virologic failures.
No patients discontinued sofosbuvir or RBV due to adverse events. The most common adverse events reported in =15 percent of patients in the study were fatigue, headache, insomnia and nausea.
Results from all four pivotal Phase 3 studies of sofosbuvir – FUSION, POSITRON, FISSION and NEUTRINO – will support the initial regulatory filing for sofosbuvir as part of all-oral therapy with RBV among genotype 2 and 3 treatment-naïve, treatment-experienced and interferon-intolerant HCV patients, and for sofosbuvir in combination with RBV and pegylated interferon among treatment-naïve patients with genotypes 1, 4, 5 and 6.
Perrigo Company (Nasdaq: PRGO) announced it has filed with the U.S. FDA an Abbreviated New Drug Application for testosterone gel 1.62% and that it has notified AbbVie Inc., the owner of the Reference Listed Drug of its filing.
On February 15, 2013, the Unimed Pharmaceuticals subsidiary of AbbVie and Besins Healthcare filed suit against Perrigo in the United States District Court for the District of Delaware, alleging patent infringement. This action formally initiates the process under the Hatch-Waxman Act. Perrigo believes that it is a first filer for this opportunity, entitling it to 180 days of generic exclusivity.
Androgel® 1.62% (testosterone gel 1.62%) is indicated to treat males who have low or no testosterone. Annual sales were approximately $680 million annually, as measured by Wolters Kluwer Health.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This filing is another example of our investment in new products and continued focus on bringing extended topicals to market. As always, Perrigo is committed to making quality healthcare more affordable for our customers and consumers."
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it will present at the RBC Capital Markets and the Citi 2013 Global Healthcare conferences in February.
Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that the Brown University Oncology Research Group (BrUOG) will be coordinating a Phase 1/2 study of ADXS-HPV in 25 patients with HPV-associated anal cancer.
AirWare Labs Corp. (OTCQB: AIRW) today shares the market outlook for its AIR® product lineup in context to products sold within the OTC (Over-the-Counter) and Natural/Homeopathic Marketplaces.
Align Technology, Inc. (NASDAQ: ALGN) announced today the launch of a new interactive web site that provides a broad range of professional education resources for Invisalign providers.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it will present at the RBC Capital Markets Healthcare Conference being held in New York City.
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced financial results for the fourth quarter and full year ended December 31, 2012.
BioMed Realty Trust, Inc. (NYSE: BMR) today announced the full exercise of the underwriters' option to purchase additional shares of common stock in connection with BioMed Realty's previously announced follow-on offering that priced on February 13, 2013.
Bruker Corporation (NASDAQ: BRKR) today reported financial results for its fourth quarter and full year ended December 31, 2012.
Capital Group Holdings, Inc. (OTCBB: CGHC) is pleased to announce it has received clearing from FINRA for its recently submitted 15c2-11 filing and its common stock is now quoted on the OTC Bulletin Board.
Capital Group Holdings, Inc. (OTCBB: CGHC) announced its consolidated results of operations for the quarter ending December 31, 2012.
China Cord Blood Corporation (NYSE: CO) (the "Company") today announced its plan to release financial results for the third quarter and first nine months of fiscal year 2013 on Tuesday, February 26, 2013, after market close in the US.
DARABiosciences (NASDAQ: DARA), a specialty pharmaceutical company focused on oncology and oncology supportive care products, is expecting to hear soon on the status of its Orphan Drug application submitted to The Food and Drug Administration (FDA) in November of last year for its drug KRN5500, which is being studied for the treatment of chronic chemotherapy-induced peripheral neuropathy (CCIPN).
DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM (NYSE, Euronext: DSM KON), announced today that it has signed a collaboration agreement with Chemtrix B.V., The Netherlands, in the field of Continuous Flow Chemistry.
Gilead Sciences (Nasdaq:GILD) today announced topline results from the Phase 3 FUSION study evaluating 12- and 16-week courses of therapy with the once-daily nucleotide sofosbuvir plus ribavirin (RBV) in treatment-experienced patients with genotype 2 or 3 chronic hepatitis C virus (HCV) infection who failed prior treatment.
GTx, Inc. (Nasdaq: GTXI) announced today that management will present a company overview on February 25, 2013 at the 2013 Citi Global Healthcare Conference in New York City. The GTx presentation will begin at 1.30 p.m. EST.
InSite Vision Incorporated (OTCBB: INSV) announced today that it will report financial results for the fourth quarter and year ended December 31, 2012 on Tuesday, March 5, 2013.
MediaTechnics Corporation (PINKSHEETS: MEDT) is pleased to announce that it executed an agreement to purchase a 51% interest in App Swarm Inc. ("ASI") in exchange for restricted preferred stock on February 11, 2012.
Mentor Capital, Inc. (Pink Sheets:MNTR) reports that its proprietary Cancer Immunotherapy Index declined (-10.9%) during 2012.
Morria Biopharmaceuticals Plc (OTCQB: MRRBY) (the "Company"), an emerging growth biopharmaceutical company focused on developing novel first-in-class, synthetic, multi-functional non-steroidal anti-inflammatory drugs, announced today that its American Depositary Shares ("ADSs") representing its ordinary shares have commenced trading on the OTC Bulletin Board in the United States under the ticker symbol MRRBY.
MMRGlobal, Inc. (OTCQB: MMRF) today announced that as a result of recent publicity, it has been brought to the Company's attention that vendors providing services to the Ministry of Health in Singapore appear to be infringing on patents (including Singapore patent number 200801954) and other Intellectual Property (collectively, the "MMR-IP") issued to MyMedicalRecords, Inc., a wholly owned subsidiary of MMRGlobal.
NanoViricides, Inc. (OTC: NNVC) (the "Company"), has filed its quarterly report with the Securities and Exchange Commission on Thursday, February 14th, in a timely fashion.
NeuroMetrix, Inc. (Nasdaq: NURO), a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes, today reported business and financial highlights for the quarter and twelve months ended December 31, 2012.
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that Dr. Mark Pykett, President and Chief Executive Officer, will participate at the Citi 2013 Global Healthcare Conference on February 25-27, 2013 at the Hilton New York Hotel in New York City.
Oncolytics Biotech Inc.("Oncolytics") (TSX:ONC; NASDAQ: ONCY) announced today its intention, subject to market and other conditions, to commence an underwritten public offering of common shares.
Osiris Therapeutics, Inc. (NASDAQ: OSIR), the leading stem cell company developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets, announced today that the European Medicines Agency (EMA) has designated Osiris as the Orphan Drug title holder for Prochymal® (remestemcel-L).
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Bayer HealthCare today announced thatthey have initiated a new Phase 3 trial (named VIVID EAST-DME) to evaluate the efficacy and safety of EYLEA® (aflibercept) Injection in the treatment of Diabetic Macular Edema (DME) in Russia, China, and other Asian countries.
RXi Pharmaceuticals Corporation (OTC: RXII), a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using RNA-targeted technologies, today announced upcoming presentations at AsiaTIDES and at the ROTH 25th Annual Conference.
Santarus, Inc. (NASDAQ: SNTS) today announced that it will release fourth quarter 2012 financial results after market close on Monday, March 4, 2013.
Sobi (STO: SOBI) and Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) announced today that they have entered into an agreement for the co-promotion of Kineret® (anakinra) in the U.S.
ServiceSource® (NASDAQ: SREV), the global leader in recurring revenue management, today announced that it has expanded its partnership with GE Healthcare (NYSE: GE) to include Japan.
Teleflex Incorporated (NYSE: TFX) announced today the addition of the AutoFuser® disposable pain pump to its portfolio of Arrow® pain management products.
Today eHealth, Inc. (NASDAQ: EHTH) (eHealthInsurance.com), America's first and largest private online health insurance exchange, released a series of tips for health insurance consumers preparing to file their 2012 federal tax returns.
United Therapeutics Corporation (NASDAQ: UTHR) announced today that it will release its fourth quarter and annual 2012 financial results before market open on Tuesday, February 26, 2013.
VentriPoint Diagnostics (TSX VENTURE:VPT) (OTCQX:VPTDF) is providing a status report on its 2D echocardiographic (2DE) products, clinical research and regulatory submission plans.
Vermillion, Inc. (NASDAQ: VRML), a molecular diagnostics company focused on gynecologic cancers and vascular medicine, has been invited to participate in Lazard Capital Market's 5th Annual Medical Technology Snowbird Conference.
Vermillion, Inc. (NASDAQ: VRML), a molecular diagnostics company focused on gynecologic cancers and vascular medicine, will hold a conference call on Wednesday, February 20, 2013, at 4:30 p.m. ET to discuss full results for its fourth quarter and year ended December 31, 2012.
Verisante Technology, Inc. (TSX VENTURE:VRS) (OTCQX:VRSEF) (FRANKFURT:V3T) (the "Company" or "Verisante"), a leader in cancer detection technology, announced today that the Company has entered into an exclusive agreement with Pacifica Handels AG to distribute Verisante Aura™ in Switzerland.
WaferGen Bio-systems, Inc. (OTCBB: WGBS) announced today a co-marketing agreement with QIAGEN KK – a subsidiary of QIAGEN N.V.– for the joint promotion of certain products in Japan in the areas of genomics platforms such as Next-Gen sequencing (NGS) and qPCR.
SPOM -SPO MEDICAL SYSTEMS due diligence
SPOM Business Description
SPO MEDICAL SYSTEMS develops and manufactures vital sign monitoring devices. Unique, patented Reflectance Pulse Oximetry (RPO) is cutting edge technology supplying rapid and reliable mobile response. RPO monitors, non-invasively, blood oxygen saturation and heart rate while attached to a single side of the body. Small low-powered battery sensors incorporate wireless functionality, accurate even during physical activity.
Conventional pulse Oximetry is limited to areas, such as fingers and earlobes. Physiological conditions such as stress and temperature can affect the accuracy of these conventional devices.
Innovative aspects:
*RPO technology sensors precisely capture vital cardiovascular parameters such as pulse rate and pulse rhythm.
*Low power consumption, enabling continuous monitoring in non-clinical environments
*Does not require tight skin contact. This prevents common occlusions and discomfort and can be worn comfortably around the clock
*Wireless monitoring functionality
*Small and lightweight, easily embedded in wristwatch-type devices
*Not limited by physical activity
A new sophisticated product developed to assist mentally disabled persons in vital sign monitoring and in preventing suicides among prisoners is currently used by the Israeli Prisons Service.
Partners are sought to distribute and provide technical support for varied product lines.
Patent's listed under CEO's name:
http://www.freepatentsonline.com/result.html?sort=relevance&srch=top&query_txt=Michael+Braunold&submit=&patents=on
Video: SPO Medical now white labeling for HoMedics and selling product at CVS
Focus on new consumer wellness products for OTC sales
NEW YORK, February 19, 2013 /PRNewswire via COMTEX/ -- SPO Medical Inc. (SPOM), a leading developer of biosensor and microprocessor technologies for use in portable monitoring devices, announced today that it has partnered with HoMedics LLC for the distribution of a private-labeled, over-the-counter (OTC) pulse oximeter for non-medical consumer wellness applications. This new product, known as the HoMedics Deluxe Pulse Oximeter is currently being promoted and sold in North America.
The oximeter is based on patented Optimetrix™ technology which uses proprietary optical techniques to measure certain vital sign measurements for a variety of consumer wellness applications. In the United States, the Deluxe Pulse Oximeter was launched during 4th quarter 2012 at CVS stores, and HoMedics sees substantial upside potential to expand in the drug channel and beyond during 2013. Furthermore, HoMedics will look to increase distribution worldwide via its extensive network in over 60 countries.
Michael Braunold, Chief Executive Officer of SPO commented: "We've been working with HoMedics since early summer 2012 and have made tremendous progress together, with the successful introduction of the HoMedics Deluxe Pulse Oximeter to US consumers. As market awareness for wellness products strengthens and grows, our partnership with the oximeter and future products under development creates promising opportunities for both companies. Our decision to distribute under the HoMedics private-label has afforded us access to mass-market retailers worldwide and we plan on expanding our product portfolio to further leverage on our joint-success to date".
SPO views the general wellness product category as a major growth opportunity by leveraging its technology to monitor information related to general leisure/sport activities. Product opportunities currently under development include a fitness watch which negates the need for the traditional chest-strap currently being used by most sports watch manufacturers, and a new consumer wellness time-piece designed to measure overall daily activity level, especially useful for overweight or obese adults and children. This product will include unique innovative features as well as being a fashionable time-piece to continuously measure the number of daily activities and calories burned against a recommended goal.
SPOM -SPO Partners with HoMedics LLC
Last update: 2/19/2013 8:30:00 AM
Focus on new consumer wellness products for OTC sales
NEW YORK, February 19, 2013 /PRNewswire via COMTEX/ -- SPO Medical Inc. (SPOM), a leading developer of biosensor and microprocessor technologies for use in portable monitoring devices, announced today that it has partnered with HoMedics LLC for the distribution of a private-labeled, over-the-counter (OTC) pulse oximeter for non-medical consumer wellness applications. This new product, known as the HoMedics Deluxe Pulse Oximeter is currently being promoted and sold in North America.
The oximeter is based on patented Optimetrix™ technology which uses proprietary optical techniques to measure certain vital sign measurements for a variety of consumer wellness applications. In the United States, the Deluxe Pulse Oximeter was launched during 4th quarter 2012 at CVS stores, and HoMedics sees substantial upside potential to expand in the drug channel and beyond during 2013. Furthermore, HoMedics will look to increase distribution worldwide via its extensive network in over 60 countries.
Michael Braunold, Chief Executive Officer of SPO commented: "We've been working with HoMedics since early summer 2012 and have made tremendous progress together, with the successful introduction of the HoMedics Deluxe Pulse Oximeter to US consumers. As market awareness for wellness products strengthens and grows, our partnership with the oximeter and future products under development creates promising opportunities for both companies. Our decision to distribute under the HoMedics private-label has afforded us access to mass-market retailers worldwide and we plan on expanding our product portfolio to further leverage on our joint-success to date".
SPO views the general wellness product category as a major growth opportunity by leveraging its technology to monitor information related to general leisure/sport activities. Product opportunities currently under development include a fitness watch which negates the need for the traditional chest-strap currently being used by most sports watch manufacturers, and a new consumer wellness time-piece designed to measure overall daily activity level, especially useful for overweight or obese adults and children. This product will include unique innovative features as well as being a fashionable time-piece to continuously measure the number of daily activities and calories burned against a recommended goal.
About SPO
SPO (SPOM) is a leading developer of biosensor and microprocessor technologies for use in portable monitoring devices to capture life-enhancing information within four key markets: medical care; sports and wellness; homecare monitoring and security. Its patented technology uses information gathered from the reflectance of light on the human body, in a noninvasive manner, to monitor key vital signs. The company manufactures its products in addition to licensing its technologies to appropriate client corporations for commercialization and distribution. For more information, visit .
About HoMedics
HoMedics is a privately held, family-owned business founded in 1987 that manufactures and markets some of the world's best known, most innovative brands in an array of consumer health, wellness and electronics lifestyle categories. HoMedics distributes its products to more than 60 countries throughout North America, South America, Central America, the Asia-Pacific region, Europe, Africa and the Middle East. For more information, visit .
Forward Looking Statements
This press release contains forward-looking statements that involve substantial uncertainties and risks. These forward-looking statements are based upon our current expectations, estimates and projections about our business and our industry, and that reflect our beliefs and assumptions based upon information available to us at the date of this release. We caution readers that forward looking statements are predictions based on our current expectations about future events. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Our actual results, performance or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including but not limited to, the realization of revenues from product orders for the HoMedics Deluxe Pulse Oximeter, the success of efforts to expand distribution of the product, the success, if any, of our efforts to expand distribution of the product to additional mass market retailers, the ability to create strategic partnerships to aid in the distribution of products, profitability, market acceptance of our products and new product applications, timing of new product launches, success of the Company's rebranding program, product performance, size of prospective markets, revenue assessments, marketing strategies, success of our restructured operations and plans, our ability to generate fees or raise capital to support our business operations and plan, the sufficiency and availability of working capital, changes in economic conditions generally and in more specifically, the introduction of competing products, changes in our operating strategy or development plans patent protection for our products and technologies, changes in economic conditions generally and in more specifically, in the markets we operate, changes in technology, legislative or regulatory changes that affect us and the risks and uncertainties discussed under the heading "Risk Factors" in Item 1 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2011. We undertake no obligation to revise or update any forward-looking statement for any reason.
Contact regarding this release:
SPO investors@spoglobal.com +1-866-991-7766
SOURCE SPO Medical Inc.
Copyright (C) 2013 PR Newswire. All rights reserved
iBio And Caliber Biotherapeutics Establish License And Collaboration Relationship
Press Release: iBio, Inc. – 8 minutes ago
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NEWARK, Del. and BRYAN, Texas, Feb. 19, 2013 /PRNewswire/ -- iBio, Inc. (NYSE MKT: IBIO), and Caliber Biotherapeutics LLC (Caliber) today announced execution of a License and Collaboration Agreement for development and production of recombinant plant-based biopharmaceuticals using iBio's proprietary iBioLaunch™ technology and Caliber's unique and proprietary plant-based manufacturing capabilities.
(Logo: http://photos.prnewswire.com/prnh/20120419/NY91086LOGO)
(Logo: http://photos.prnewswire.com/prnh/20130219/NY61582LOGO)
The new relationship establishes a turn-key plant-based biopharmaceutical development capability, from the earliest stage of product selection and optimization through large-scale production. iBio and Caliber will use their combined capabilities for their own product portfolios, starting with an undisclosed monoclonal antibody for oncology indications, where Caliber and its affiliates have demonstrated expertise. The Companies also will make their combined capabilities available to third parties through licensing and partnering arrangements for other recombinant plant-based biotherapeutics and vaccines.
iBio's patented iBioLaunch™ technology, developed over nine years at a cost of more than US$100 million, causes common green plants to produce commercial quantities of targeted human proteins in proper form for use as the active pharmaceutical ingredients for the development and production of biopharmaceuticals. Caliber owns and operates the world's largest-capacity cGMP commercial manufacturing facility for plant-made biopharmaceutical products.
iBio's technology platform is broadly applicable to recombinant vaccines and biotherapeutic products, including: monoclonal antibodies; proteins otherwise derived from blood plasma; and replacement enzymes used to treat a variety of orphan diseases. The technology has demonstrated capabilities to express proteins that were not commercially feasible to produce using other systems, and unlike technologies dependent on transgenic cells and organisms, utilizes advanced informatics and new synthetic biology techniques for superior clinical product design and delivery. Human clinical trials of product candidates produced with iBio's technology have been funded by the U.S. Department of Defense and the Bill & Melinda Gates Foundation.
Caliber's current facility capacity for therapeutic protein at typical yields is over 300 kilograms of active pharmaceutical ingredient per year (which would yield around one billion doses of a typical subunit vaccine product or 300,000 doses of a typical antibody product), which can be quickly expanded based on demand. The facility design enables concurrent development and production of multiple products and rapid changeover. The Caliber facility together with the iBioLaunch™ technology also enables extraordinary surge capacity for vaccines and biotherapeutics against pandemic disease and bioterrorism.
Under the terms of the agreement, iBio will receive license and milestone fees for development of product targets selected by Caliber. Caliber will be responsible for funding clinical development and commercialization of such collaboration products, and iBio will receive royalties on product sales and other revenues. Detailed financial terms of the agreement have not been disclosed.
"This combination is a major advance for recombinant biopharmaceuticals," said Robert B. Kay, Executive Chairman and CEO of iBio. "By bringing together our intellectual property, facilities, and know-how, we not only will accelerate and improve development of our own product pipelines, but also enable third-party developers and sponsors to access turn-key solutions for their product candidates through licenses and partnerships with us."
Dr. Rahul Singhvi, Managing Director of Caliber Biotherapeutics, stated: "This new collaboration with iBio enables us to develop products addressing important unmet medical needs that uniquely benefit from Nicotiana benthamiana plant-based expression technology. The combination of iBio's state-of-the-art expression technology and Caliber's innovative manufacturing infrastructure makes the promise of plant-based pharmaceuticals very real. We are excited about combining our joint capabilities to create valuable products that would otherwise be commercially impossible to produce or develop."
About iBio, Inc.
iBio develops and offers product applications of its iBioLaunch™ and iBioModulator™ platforms, providing collaborators full support for turn-key implementation of its technology for both proprietary and biosimilar products. The iBioLaunch platform is a proprietary, transformative technology for development and production of biologics using transient gene expression in unmodified green plants. Advantages over other systems include: success with proteins difficult or impossible to produce with other methods; broadly applicable to biologics, including therapeutic proteins and vaccines; production time measured in weeks instead of months or more. Additional benefits include a practically unlimited surge capacity for remedial action against bioterrorism and pandemic disease; product entry that is unconstrained by traditional process patents, and significantly lower capital and operating costs for comparable production. The iBioModulator platform is complementary to the iBioLaunch platform and enables significantly improved vaccine products with higher potency and greater duration of effect. The iBioModulator platform can be used with any recombinant expression technology for vaccine development and production. Further information is available at: www.ibioinc.com.
About Caliber Biotherapeutics, LLC
Caliber Biotherapeutics, LLC is a biotechnology company based in Bryan, Texas with a mission to develop and commercialize protein-based therapeutics that improve outcomes for patients with cancer and other diseases. The Company utilizes technological innovations in biological research, product development and manufacturing to create treatments with increased safety and effectiveness--while reducing both costs and development time. Caliber has created a rich pipeline of monoclonal antibody-based products, including biobetter product candidates applying its expertise in the Nicotiana benthamiana plant-based expression and manufacturing of recombinant proteins. Caliber operates the world's largest N. benthamiana expression based protein manufacturing facility, in Bryan, Texas. For more information, please visit www.caliberbio.com.
Forward-Looking Statements
Statements included in this news release related to iBio, Inc. may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve a number of risks and uncertainties such as competitive factors, technological development, market demand, and the Company's ability to obtain new contracts and accurately estimate net revenues due to variability in size, scope and duration of projects. Further information on potential risk factors that could affect the Company's financial results can be found in the company's reports filed with the Securities and Exchange Commission.
Caliber Safe Harbor:
This release contains forward-looking statements that are not based on historical fact. These forward-looking statements involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. Readers are cautioned not to place undue reliance on such forward-looking statements.
Contacts
iBio, Inc.
Corporate:
Robert Erwin, President
302-355-2335
rerwin@ibioinc.com
Caliber Biotherapeutics, LLC
Rahul Singhvi, Managing Director
240-308-0225
rsinghvi@caliberbio.com
ADXS Announces Phase 1/2 Trial of ADXS-HPV in Anal Cancer Conducted by Brown University Oncology Group
Press Release: Advaxis, Inc. – 8 minutes ago
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PRINCETON, N.J.--(BUSINESS WIRE)--
Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that the Brown University Oncology Research Group (BrUOG) will be coordinating a Phase 1/2 study of ADXS-HPV in 25 patients with HPV-associated anal cancer. Dr. Howard Safran, professor of medicine, will be principal investigator. Patients will be treated at Rhode Island Hospital and The Miriam Hospital (the main teaching hospitals of The Warren Alpert Medical School of Brown University). Multiple institutions will collaborate.
This non-randomized, open-label, multi-center study will evaluate the safety and effectiveness of ADXS-HPV when combined with standard chemotherapy and radiation treatment for anal cancer. The primary objectives of the trial include the evaluation of adverse events and the evaluation of 6-month clinical response. The study is expected to open for enrollment February 2013.
“We are pleased that the Brown University Oncology Research Group is coordinating this study in anal cancer using Advaxis’ lead construct ADXS-HPV,” commented Dr. Robert Petit, Vice President of Clinical Operations & Medical Affairs at Advaxis. “This study is an important first step in evaluating the combination of ADXS-HPV immunotherapy with the standard of care in HPV-associated cancers like anal cancer. The investigation of ADXS-HPV across a number of indications and in combination with other therapies will help us learn how best to use Advaxis immunotherapy to benefit patients with HPV-associated cancers. The anal cancer study will continue to build the safety and efficacy profile of our immunotherapy platform.”
About ADXS-HPV for Anal Cancer
Virtually all cases of squamous cell cancer (SCC) of the anus are caused by a Human Papilloma Virus (HPV) infection. Anal cancer cells infected with HPV have the tumor associated antigen HPV E7. ADXS-HPV causes antigen presenting cells to stimulate other immune cells to attack cancer expressing HPV E7. In Phase 1 clinical trials and preliminary data from ongoing Phase 2 trials, ADXS-HPV has been safely administered to 193 patients with other HPV-associated diseases (recurrent/refractory cervical cancer and CIN 2/3), and has demonstrated clinical benefit as a single agent or in combination with chemotherapy.
About Advaxis, Inc.
Advaxis is a clinical-stage biotechnology company developing the next generation of immunotherapies for cancer and infectious diseases. Advaxis immunotherapies are based on a novel platform technology using live, attenuated bacteria that are bio-engineered to secrete antigen/adjuvant fusion protein(s) designed to redirect the powerful immune response all human beings have to the bacterium to the cancer itself.
In April 2012, Advaxis’ lead construct, ADXS-HPV, was selected as the Best Therapeutic Vaccine (approved or in development) at the 5th Annual Vaccine Industry Excellence (ViE) Awards by the vaccine industry and the journal Expert Reviews of Vaccines. The ViE awards, sponsored by Novartis Vaccines and Diagnostics, were created to recognize the accomplishments and contributions of companies and individuals in the vaccine industry over the previous 12 months. Additional information is available at the World Vaccine Congress website.
ADXS-HPV is being evaluated in 5 clinical trials for HPV-associated diseases: recurrent/refractory cervical cancer (India), locally advanced cervical cancer (GOG/NCI US study, Clinical Trials.gov Identifier NCT01266460), CIN 2/3 (US study, Clinical Trials.gov Identifier NCT01116245), head & neck cancer (CRUK study, Clinical Trials.gov Identifier NCT01598792), and anal cancer (BrUOG study, Clinical Trial.gov Identifier NCT01671488). Over fifteen (15) distinct constructs are in various stages of development, developed directly by the Company and through strategic collaborations with recognized centers of excellence such as: the National Cancer Institute, Cancer Research – UK, the Wistar Institute, the University of Pennsylvania, the University of British Columbia, the Karolinska Institutet, Brown University Oncology Group, and others. For more information please visit: advaxis.com | Facebook | twitter | LinkedIn
Forward-Looking Statements
This news release contains forward-looking statements, including, but not limited to: statements as to the anticipated timing of clinical studies and other business developments, statements as to the development of new constructs, expectations as to the adequacy of our cash balances to support our operations for specified periods of time and as to the nature and level of cash expenditures, expectations as to market opportunities, our ability to take advantage of those opportunities, and the risk factors set forth from time to time in Advaxis' SEC filings, including but not limited to its report on Form 10-K for the fiscal year ended October 31, 2012, which is available at www.sec.gov. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. You are cautioned not to place undue reliance on any forward-looking statements.
Contact:
Advaxis, Inc.
Diana Moore, 609-452-9814
Director, Investor Relations & Business Development
ir@advaxis.com
NVS Novartis' drug Zortress approved by FDA to prevent organ rejection in adult liver transplant patients (NVS) 69.20 : Co announces the FDA has approved Zortress for the prophylaxis of organ rejection in adult patients receiving a liver transplant. Zortress is the first mammalian target of rapamycin (mTOR) inhibitor approved for use following liver transplantation. It is also the first immunosuppressant approved by the FDA in over a decade for use following liver transplantation. The approval was based on the largest liver transplant study to date, which showed that Zortress plus reduced tacrolimus led to comparable efficacy and 10mL/min higher renal function as measured by estimated glomerular filtration rate for Zortress compared to standard tacrolimus at 12 months.
GILD -Gilead Sciences issues a voluntary recall of one lot of Vistide due to presence of particulate matter (GILD) 41.60 : Co announces it is voluntarily recalling lot B120217A of Vistide to the user level due to the presence of particulate matter found in some vials of this lot. Effects from intravenous injection of product with particulate matter can vary depending on the amount of particulate matter injected into the patient, the size of the particles and the patient's underlying medical condition, and can be severe. co is not currently aware of any complaint attributable to the particles.
OSIR Receives Title of European Orphan Drug Designation for Prochymal®
Press Release: Osiris Therapeutics, Inc. – 32 minutes ago
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OSIR 7.02
COLUMBIA, Md.--(BUSINESS WIRE)--
Osiris Therapeutics, Inc. (OSIR), the leading stem cell company developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets, announced today that the European Medicines Agency (EMA) has designated Osiris as the Orphan Drug title holder for Prochymal® (remestemcel-L).
The EU Commission adopted the decision to transfer the designation of Prochymal (ex-vivo cultured adult human mesenchymal stem cells) as an orphan medicinal product under Regulation (EC) No 141/2000 of the European Parliament and of the Council. The Decision will appear in the EU Community Register of Orphan Medicinal Products.
In Europe, Orphan Drug designation provides a variety of incentives, including market exclusivity for up to 10 years following approval, to companies that develop drugs for underserved patient populations.
In the EU, the Orphan Drug designation for Prochymal is for the treatment of acute graft versus host disease (GvHD). Prochymal, a first-in-class allogeneic stem cell therapy, has already received approval in Canada and New Zealand for the treatment of acute GvHD in children, and is currently available in seven other countries including the United States under an Expanded Access Program (EAP). Recently, Swissmedic, the Swiss agency responsible for the evaluation of drugs, notified Osiris that Prochymal will be evaluated under its Rapid Authorization Procedure upon submission of the marketing application.
About Prochymal (remestemcel-L)
Prochymal is the world’s first approved drug with a stem cell as its active ingredient. Developed by Osiris Therapeutics, Prochymal is an intravenous formulation of MSCs, which are derived from the bone marrow of healthy adult donors between the ages of 18 and 30 years. The MSCs are selected from the bone marrow and grown in culture so that up to 10,000 doses of Prochymal can be produced from a single donor. Prochymal is truly an off-the-shelf stem cell product that is stored frozen at the point-of-care and infused through a simple intravenous line without the need to type or immunosuppress the recipient. Prochymal is approved in Canada and New Zealand for the management of acute GvHD in children and is available for adults and children in eight countries including the United States, under an Expanded Access Program. Prochymal is currently in a Phase 3 trial for refractory Crohn’s disease and in a Phase 2 trial for acute myocardial infarction.
About Osiris Therapeutics
Osiris Therapeutics, Inc., having developed the world’s first approved stem cell drug, Prochymal®, is the leading stem cell company. The company is focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets. In Biosurgery, Osiris currently markets Grafix® for burns and chronic wounds, and Ovation® for orthopedic applications. Osiris is a fully integrated company with capabilities in research, development, manufacturing and distribution of stem cell products. Osiris has developed an extensive intellectual property portfolio to protect the company's technology, including 50 U.S. and 156 foreign patents.
Osiris, Prochymal, Chondrogen, Grafix and Ovation are registered trademarks of Osiris Therapeutics, Inc. More information can be found on the company's website, www.Osiris.com. (OSIR-G)
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements include statements about our expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as "anticipate," "believe," "continue," "ongoing," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project" or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Examples of forward-looking statements may include, without limitation, statements regarding any of the following: our product development efforts; our clinical trials and anticipated regulatory requirements, and our ability to successfully navigate these requirements; the success of our product candidates in development; status of the regulatory process for our biologic drug candidates; implementation of our corporate strategy; our financial performance; our product research and development activities and projected expenditures, including our anticipated timeline and clinical strategy for mesenchymal stem cells and biologic drug candidates and marketed Biosurgery products (including Prochymal, Chondrogen, Grafix and Ovation); our cash needs; patents, trademarks and other proprietary rights; the safety and ability of our products and potential products to treat disease; our ability to supply a sufficient amount of our marketed products or product candidates and, if approved or otherwise commercially available, products to meet demand; our costs to comply with governmental regulations; our plans for sales and marketing; our plans regarding facilities; types of regulatory frameworks we expect will be applicable to our products and potential products; and results of our scientific research. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Our actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the section entitled "Risk Factors" in our Annual Report on Form 10-K and other Periodic Reports filed on Form 10-Q, with the United States Securities and Exchange Commission. Accordingly, you should not unduly rely on these forward-looking statements. We undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this press release or to reflect the occurrence of unanticipated events.
Contact:
Osiris Therapeutics, Inc.
Erica Elchin, 443-545-1834
OsirisPR@Osiris.com
GSK and Theravance Announce FDA Acceptance of New Drug Application (NDA) Submission in the US for ANORO ELLIPTA(TM) for COPD
Press Release: Theravance, Inc. – 32 minutes ago
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GSK.L 1,469.00 -4.50
LONDON and SOUTH SAN FRANCISCO, CA--(Marketwire - Feb 19, 2013) - GlaxoSmithKline plc (GSK.L) and Theravance, Inc. ( NASDAQ : THRX ) today announced that the New Drug Application (NDA) for the investigational once-daily LAMA/LABA combination medicine, UMEC/VI, for patients with chronic obstructive pulmonary disease (COPD), has been accepted by the U.S. Food and Drug Administration (FDA) indicating that the application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act (PDUFA) goal date has also been confirmed as 18 December 2013.
In December 2012 and January 2013, GSK and Theravance announced the submission by GSK of regulatory applications in the United States and the European Union, respectively, for UMEC/VI for patients with COPD. The Marketing Authorisation Application (MAA) for UMEC/VI has been validated for assessment by the European Medicines Agency (EMA).
UMEC/VI, with proposed brand name ANORO™, is a combination of two investigational bronchodilator molecules - GSK573719 or umeclidinium bromide (UMEC), a long-acting muscarinic antagonist (LAMA) and vilanterol (VI), a long-acting beta2 agonist (LABA), administered using the ELLIPTA™ inhaler.
Future Regulatory Submissions:
Regulatory submissions for UMEC/VI are planned in other countries during the course of 2013. In addition, GSK intends to commence global regulatory submissions for UMEC monotherapy, administered using the ELLIPTA™ inhaler, for COPD patients later this year.
Other Respiratory Development Programmes:
UMEC/VI is one of several late-stage assets in the GSK respiratory development portfolio, which includes fluticasone furoate/vilanterol (FF/VI, with proposed brand names RELVAR™ and BREO™), VI monotherapy and MABA (GSK961081), developed in collaboration with Theravance, as well as GSK's investigational medicines FF monotherapy, UMEC monotherapy and anti-IL5 MAb (mepolizumab). These investigational medicines are not currently approved anywhere in the world.
ANORO™, RELVAR™, BREO™ and ELLIPTA™ are trademarks of the GlaxoSmithKline group of companies. The use of these brand names is not approved by any regulatory authorities.
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
Theravance - is a biopharmaceutical company with a pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical companies. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections, and central nervous system (CNS)/pain. Theravance's key programs include: RELVAR™ or BREO™ (FF/VI), ANORO™ (UMEC/VI) and MABA (Bifunctional Muscarinic Antagonist-Beta2 Agonist), each partnered with GlaxoSmithKline plc, and its oral Peripheral Mu Opioid Receptor Antagonist program. By leveraging its proprietary insight of multivalency to drug discovery, Theravance is pursuing a best-in-class strategy designed to discover superior medicines in areas of significant unmet medical need. For more information, please visit Theravance's web site at www.theravance.com.
THERAVANCE®, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of Theravance, Inc.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2011.
Theravance forward-looking statement
This press release contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives and future events. Theravance intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to the status and timing of clinical studies, data analysis and communication of results, statements regarding the potential benefits and mechanisms of action of drug candidates, statements concerning the timing of seeking regulatory approval of our product candidates, statements concerning the enabling capabilities of Theravance's approach to drug discovery and its proprietary insights, and statements concerning expectations for the discovery, development and commercialization of our product candidates. These statements are based on the current estimates and assumptions of the management of Theravance as of the date of this press release and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance to be materially different from those reflected in its forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to delays or difficulties in commencing or completing clinical and non-clinical studies, the potential that results of clinical or non-clinical studies indicate product candidates are unsafe or ineffective, our dependence on third parties in the conduct of our clinical studies, delays or failure to achieve regulatory approvals for product candidates, risks of relying on third-party manufacturers for the supply of our product and product candidates and risks of collaborating with third parties to discover, develop and commercialize products. These and other risks are described in greater detail under the heading "Risk Factors" contained in Theravance's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on October 31, 2012 and in Theravance's prospectus supplement filed with the SEC on January 18, 2013 pursuant to Rule 424(b)(5). Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance assumes no obligation to update its forward-looking statements.
(THRX-G)
Contact:
GlaxoSmithKline Enquiries:
UK Media enquiries:
David Mawdsley
+44 (0) 20 8047 5502
(London)
Stephen Rea
+44 (0) 20 8047 5502
(London)
Sarah Spencer
+44 (0) 20 8047 5502
(London)
David Daley
+44 (0) 20 8047 5502
(London)
US Media enquiries:
Kevin Colgan
+1 919 483 2933
(North Carolina)
Melinda Stubbee
+1 919 483 2510
(North Carolina)
Sarah Alspach
+1 202 715 1048
(Washington, DC)
Jennifer Armstrong
+1 215 751 5664
(Philadelphia)
Analyst/Investor enquiries:
Sally Ferguson
+44 (0) 20 8047 5543
(London)
Tom Curry
+ 1 215 751 5419
(Philadelphia)
Gary Davies
+ 44 (0) 20 8047 5503
(London)
James Dodwell
+ 44 (0) 20 8047 2406
(London)
Jeff McLaughlin
+ 1 215 751 7002
(Philadelphia)
Ziba Shamsi
+ 44 (0) 20 8047 3289
(London)
Theravance Inc. Enquiries
Michael W. Aguiar
Investor.relations@theravance.com
(650) 808 4100
(San Francisco)
Dynavax (NASDAQ: DVAX is expected to face FDA firing squad on or before Feb. 24 for its hepatitis-B vaccine, Hepislav. Dynavax shares were massacred shortly after the FDA panel released its findings on Hepislav, not because of the data -- panel members voted 13-1 in favor of recommending the drug based on efficacy -- but because of an 8-5 vote, with one abstention, that there wasn't enough safety data available to determine that the drug was safe, given a few cases where Hepislav caused rare autoimmune diseases. Although the FDA is under no obligation to side with the panel, it often serves as a good indicator of what to expect. I'd be shocked with an FDA approval next week, but I do expect that, at some point over the next 12-18 months, Dynavax will gain approval for Hepislav.
On the earnings front, we have a fantastic mix of biotech, medical devices, nutritional products, and a health-benefits solution provider this week.
My personal No. 1 biotech to watch in 2013, Exelixis (NASDAQ: EXEL ) , is scheduled to report fourth-quarter results on Thursday, and it probably won't include any major surprises. What I'll be looking for, however, is the company's updated 2013 sales forecast now that Cometriq, its metastatic medullary thyroid cancer drug, is available in the United States. I'd keep your eye on Exelixis' cash balance, but I don't think it'll dip all too much. Cometriq's sales forecast could be the factor that causes this company to move up or down in a big way.
Medical-device giant Medtronic (NYSE: MDT ) is slated to report its third-quarter results on Tuesday, with the expectation that revenue will advance 3% to $4.03 billion and EPS will jump to $0.91 from $0.84 in the year-ago period. For me and investors, this will give us a better look -- especially with regard to guidance -- at how the medical-device excise tax is affecting Medtronic's bottom line. Another key point will be how, if at all, St. Jude Medical's lead safety issues with regard to defibrillators are affecting Medtronic's cardiovascular device line. Medtronic is never a report to miss, so keep your eye on this one.
Highly embattled nutritional-products supplier Herbalife (NYSE: HLF ) is also slated to report its fourth-quarter results on Tuesday. Wall Street's expectations are for 19% sales growth to $1.05 billion and for EPS to expand to $1.03 from $0.86 in the previous year. Normally these results wouldn't take center stage, but with activist investors Bill Ackman, who has a gigantic short position, and Carl Icahn, who has disclosed a very sizable long position, involved, the implications of this report are enormous. Herbalife's business has always concerned me from a customer loyalty aspect, and I'm avoiding the stock at the moment, but that won't keep me from thoroughly examining its fourth-quarter results and 2013 forecast.
Last, but certainly not least, health-benefits provider Express Scripts (NASDAQ: ESRX ) has said "no" to taking the day off on Monday and is expected to report its fourth-quarter results on that date. These results will include Express Scripts' figures since the resolution of its spat with Walgreen in September. Another key point worth watching is how the company is advancing with regard to synergies associated with its gigantic Medco Health Solutions purchase. A few months ago, the companies looked ahead of schedule with their integration but then appeared to take a step back in the third quarter, when low utilization rates and in-member attrition sacked revenue growth. This synergy will be the key to driving growth going forward and is a point worth keying in on.
http://www.fool.com/investing/general/2013/02/17/5-cant-miss-health-care-events-this-week-3.aspx
REGN and Bayer Initiate Phase 3 Trial of EYLEA® (aflibercept) Injection for the Treatment of Diabetic Macular Edema in Asia and Russia
Press Release: Regeneron Pharmaceuticals, Inc. – 4 hours ago
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REGN 164.93
TARRYTOWN, N.Y. and BERLIN, Feb. 19, 2013 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (REGN) and Bayer HealthCare today announced that they have initiated a new Phase 3 trial (named VIVID EAST-DME) to evaluate the efficacy and safety of EYLEA® (aflibercept) Injection in the treatment of Diabetic Macular Edema (DME) in Russia, China, and other Asian countries. The companies are extending their global development program for EYLEA in DME after promising results in the global Phase 2 DME program.
"DME is a leading cause of vision loss in adults under the age of 50 suffering from diabetes and represents a significant unmet medical need, especially in China, where currently the only therapy for DME is macular laser photocoagulation," said Kemal Malik, M.D., member of the Bayer HealthCare Executive Committee and Head of Global Development. "With this new trial, we look forward to potentially bringing another treatment option to patients with DME in Asia and Russia."
EYLEA was approved in the United States for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD) in November 2011 and for Macular Edema following Central Retinal Vein Occlusion (CRVO) in September 2012. In Japan EYLEA was approved for use in wet AMD in September 2012. EYLEA was also approved in Europe, Australia, and in several other countries for use in wet AMD last year.
Bayer HealthCare and Regeneron are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer HealthCare licensed the exclusive marketing rights outside the United States, where the companies will share equally the profits from any future sales of EYLEA, except for Japan where Regeneron will receive a royalty on net sales.
About the Phase 3 DME Program
The VIVID EAST-DME study (VEGF Trap-Eye In Vision Impairment Due to DME) has three treatment arms. In the first arm, patients will be treated every month with 2 milligrams (mg) of EYLEA. In the second arm, patients will be treated with 2mg of EYLEA every two months after an initial phase of five monthly injections. In the third arm, the comparator arm, patients will be treated with macular laser photocoagulation. The primary endpoint is mean change in visual acuity from baseline to week 52 as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart, a standard chart used in research to measure visual acuity. All patients will be followed for a maximum of one year.
The first Phase 3 trial of EYLEA in DME, named VIVID-DME, is being conducted in Europe and Japan by Bayer HealthCare and is fully enrolled. A second study led by Regeneron, named VISTA-DME, is being conducted in the United States and is fully enrolled as well.
About Diabetic Macular Edema (DME)
DME is the most prevalent cause of moderate vision loss in patients with diabetes. DME is a common complication of Diabetic Retinopathy (DR), a disease affecting the blood vessels of the retina. Clinically significant DME is a leading cause of blindness in younger adults (under 50). Clinically significant DME occurs when fluid leaks into the center of the macula, the light-sensitive part of the retina responsible for sharp, direct vision. Fluid in the macula can cause severe vision loss or blindness.
DME is the most frequent cause of blindness in young and mid-aged adults. The treatable population for DME globally is estimated at about 6.2 million people. According to the American Diabetes Association, over 18 million Americans currently suffer from diabetes, and many more are at risk for developing diabetes. The incidence of diabetes is steadily climbing and it is projected that up to seven percent of all patients with diabetes will develop DME during their lifetime.
About EYLEA® (aflibercept) Injection For Intravitreal Injection
Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body. Its normal role in a healthy organism is to trigger formation of new blood vessels (angiogenesis) supporting the growth of the body's tissues and organs. However, in certain diseases, such as wet age-related macular degeneration, it is also associated with the growth of abnormal new blood vessels in the eye, which exhibit abnormal increased permeability that leads to edema. Scarring and loss of fine-resolution central vision often results. In Central Retinal Vein Occlusion (CRVO), a blockage occurs in the main blood vessel that transports deoxygenated blood away from the retina. VEGF levels are elevated in response contributing to macular edema.
EYLEA is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration. EYLEA acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF) and thereby can inhibit the binding and activation of these cognate VEGF receptors. EYLEA is specially purified and contains iso-osmotic buffer concentrations, allowing for injection into the eye.
Additional Phase 3 trials are currently underway with EYLEA in the treatment of myopic choroidal neovascularization (mCNV) in Asia and Macular Edema following Branch Retinal Vein Occlusion (BRVO) in United States, Canada and Japan.
IMPORTANT U.S. PRESCRIBING INFORMATION FOR EYLEA® (aflibercept) INJECTION
In the United States, EYLEA® (aflibercept) Injection is indicated for the treatment of patients with neovascular (Wet) Age-related Macular Degeneration (AMD). The recommended dose for EYLEA is 2 mg administered by intravitreal injection every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every 8 weeks (2 months). Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated when EYLEA was dosed every 4 weeks compared to every 8 weeks.
In the United States, EYLEA is also indicated for the treatment of patients with Macular Edema following Central Retinal Vein Occlusion (CRVO). The recommended dose for EYLEA is 2 mg administered by intravitreal injection every 4 weeks (monthly).
IMPORTANT SAFETY INFORMATION FOR EYLEA® (aflibercept) INJECTION
EYLEA® (aflibercept) Injection is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or to any of the excipients in EYLEA.
Intravitreal injections, including those with EYLEA, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering EYLEA. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. Intraocular inflammation has been reported during the post approval use of EYLEA.
Acute increases in intraocular pressure have been seen within 60 minutes of intravitreal injection, including with EYLEA. Sustained increases in intraocular pressure have also been reported after repeated intravitreal dosing with VEGF inhibitors. Intraocular pressure and the perfusion of the optic nerve head should be monitored and managed appropriately.
There is a potential risk of arterial thromboembolic events (ATEs) following use of intravitreal VEGF inhibitors, including EYLEA, defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The incidence of ATEs in the VIEW 1 and VIEW 2 wet AMD studies in patients treated with EYLEA was 1.8% during the first year. The incidence of ATEs in the COPERNICUS and GALILEO CRVO studies was 0% in patients treated with EYLEA compared with 1.4% in patients receiving sham control during the first six months.
The most common adverse reactions (5% or more) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.
Serious adverse reactions related to the injection procedure have occurred in < 0.1% of intravitreal injections with EYLEA including endophthalmitis, traumatic cataract, increased intraocular pressure, and vitreous detachment.
Please see the full Prescribing Information at www.EYLEA.com.
About Regeneron Pharmaceuticals
Regeneron is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, rheumatoid arthritis, and asthma. For additional information about the company, please visit www.regeneron.com.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 17.2 billion (2011), is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec 31, 2011) and is represented in more than 100 countries. More information at www.healthcare.bayer.com.
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Regeneron Forward-Looking Statements
This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron, and actual events or results may differ materially from these forward-looking statements. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron's products, product candidates and research and clinical programs now underway or planned, including without limitation the VIVID EAST-DME Study, unforeseen safety issues resulting from the administration of products and product candidates in patients, the likelihood and timing of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates, determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's products and drug candidates, competing drugs and drug candidates that may be superior to Regeneron's products and drug candidates, uncertainty of market acceptance of Regeneron's products and drug candidates, unanticipated expenses, the costs of developing, producing, and selling products, the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi and Bayer HealthCare, to be canceled or terminated, and risks associated with third party intellectual property and pending or future litigation relating thereto. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2012. Regeneron does not undertake any obligation to update publicly any forward-looking statement, whether as a result of new information, future events, or otherwise, unless required by law.
Bayer Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Regeneron Contact:
Corporate Communications
Investor Relations
Peter Dworkin
Michael Aberman, M.D.
Tel: 1 (914) 847-7640
Tel: 1 (914) 847-7799
peter.dworkin@regeneron.com
michael.aberman@regeneron.com
Bayer Contact:
Doreen Schroeder, Tel. +49 30 468-11399
doreen.schroeder@bayer.com
Find more information at www.bayerpharma.com
Follow us on Twitter: https://twitter.com/BayerHealthCare
Well lookie lookie whose buzzing:) ty babe for the shout out to bring me to see the new board Awesome Stuff.. Marked and loaded, cheer's
BIO updates Tuesday February 12, 2013
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) shares are up more than 14 percent Tuesday morning following results from the Phase 3 (PICASSO 3) trial of palifosfamide (ZIO-201) in first-line metastatic soft tissue sarcoma which reached its target number of progression-free survival (PFS) events. PICASSO 3 is an international, randomized, double-blind, placebo-controlled trial whose primary endpoint is PFS. According to the protocol and statistical plan, reaching the target number of PFS events leads to completion of the blinded data collection process and then formal efficacy analysis by the IDMC (Independent Data Monitoring Committee). The Company will announce topline results from this trial during the last week of March 2013.
"Reaching the target number of progression events for PICASSO 3 positions us one step closer to understanding palifosfamide's full potential for this significant unmet medical need," said Jonathan Lewis, M.D., Ph.D., Chief Executive Officer of ZIOPHARM. "With a positive study outcome, palifosfamide has the potential to become the first new treatment option in nearly 30 years for patients with first-line metastatic soft tissue sarcoma."
StemCells, Inc. (Nasdaq: STEM) announced the twelve-month data from the first patient cohort in the Company's Phase I/II clinical trial of its proprietary HuCNS-SC® product candidate (purified human neural stem cells) for chronic spinal cord injury continued to demonstrate a favorable safety profile, and showed that the considerable gains in sensory function observed in two of the three patients at the six-month assessment have persisted. The third patient remains stable. A summary of the data was presented today by Martin McGlynn, President and CEO, at the 15^th Annual BIO CEO & Investor Conference. By completing the twelve-month assessment, the first patient cohort has now completed the trial, and has entered into a separate follow-up study for long-term observation.
"The multi-segment gains observed in sensory function in two patients at six months have endured at the 12-month assessment. In addition, between the six- and 12-month evaluations, one patient converted from a complete to an incomplete injury," said Armin Curt, M.D., Professor and Chairman of the Spinal Cord Injury Center at Balgrist University Hospital, University of Zurich and principal investigator of the clinical trial. "Importantly, the persistence of these sensory gains at the 12-month evaluation was seen across more than one clinical measure. While much more clinical research needs to be done to demonstrate efficacy, the types of changes we are observing are unexpected and very encouraging given that these are patients in the chronic stage of complete spinal injury."
Mr. McGlynn added, "While we need to be cautious when interpreting data from a small, uncontrolled trial, to our knowledge, this is the first time a patient with a complete spinal cord injury has been converted to a patient with an incomplete injury following transplantation of neural stem cells. We are encouraged that the cells appear to convey clinical benefit in such severely injured patients. We are therefore hopeful that we will see similar or greater benefit in AIS B and C patients, who already have partial sensation and motor function below the level of injury which could be further augmented by cell transplantation."
Patients in the study's first cohort all suffered a complete injury to the thoracic (chest-level) spinal cord. In a complete injury, there is no neurological function below the level of injury, and sensory function of all three patients was stable before transplantation of the HuCNS-SC cells. All three patients were transplanted four to nine months after injury with a dose of 20 million cells at the site of injury. The surgery, immunosuppression and the cell transplants have been well tolerated by all the patients. There were no abnormal clinical, electrophysiological or radiological responses to the cells, and all the patients have remained neurologically stable through the first 12 months following transplantation. Positive changes in sensitivity to touch, heat and electrical stimuli were observed in well-defined and consistent thoracic regions in two of the patients, while no changes were observed in the third patient. Importantly, quantitative tests of specific sensory function, as well as electrophysiological measures of impulse transmission across the site of injury, show an association with the clinical examination, providing further objective confirmation of the sensory gains.
AMRI (Nasdaq: AMRI) today reported financial and operating results for the fourth quarter and full year ended December 31, 2012.
Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) today announced that executive management will participate in the Leerink Swann Global Healthcare Conference to be held February 13-14, 2013 at the Waldorf Astoria Hotel in New York City.
Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, will release results for the fourth quarter and full year 2012 on Tuesday, February 26, 2013 before the opening of the U.S. financial markets.
AVEO Oncology (NASDAQ:AVEO) and Astellas Pharma Inc. (TSE:4503) today announced overall survival (OS) for tivozanib, an investigational agent, from the Phase 3 TIVO-1 (TIvozanib Versus sOrafenib in 1st line advanced RCC) study in patients with advanced renal cell carcinoma (RCC).
BIOLASE, Inc. (NASDAQ: BIOL), the world's leading manufacturer and distributor of dental lasers, announced today that the Company was recognized with the "Best AEEDC Dubai Booth Activities Award" for the recent UAE International Dental Conference & Arab Dental Exhibition (AEEDC Dubai) held from February 5 - 7, 2013, in Dubai, United Arab Emirates.
BioMed Realty Trust, Inc. (NYSE: BMR) (the "Company"), a real estate investment trust (REIT) that delivers optimal real estate solutions for the life science industry, today announced that it delivered a notice of the Company's intention to redeem all 7,920,000 outstanding shares of its 7.375% Series A Cumulative Redeemable Preferred Stock (the "Series A preferred stock") (NYSE: BMRPrA; CUSIP No.: 09063H206) from the registered holders of the Series A preferred stock.
Bristol-Myers Squibb Company (NYSE: BMY) today announced it has entered into a three-year collaboration agreement with Reckitt Benckiser Group plc (LSE: RBL) for several of its over-the-counter medicines currently sold across Latin America, primarily in Mexico and Brazil.
Desert Gateway (OTCPK: RTRX), the parent company of Retrophin, Inc., a biotechnology company focused on discovering and developing treatments for rare and life-threatening diseases, today announced it has entered definitive agreements with institutional investors in connection with a private placement, or PIPE financing.
Given Imaging Ltd. (NASDAQ: GIVN) today announced financial results for the fourth quarter and fiscal year ended December 31, 2012.
GTx, Inc. (Nasdaq: GTXI) announced today a webcast discussing Capesaris®(GTx-758) and it’s potential role in the treatment of advanced prostate cancer in men is scheduled for Friday, February 15th 2013, from 9:00am – 10:00am Eastern Time.
ImmunoGen, Inc. (NASDAQ: IMGN), a biotechnology company that develops targeted anticancer therapeutics, today announced that it has completed patient enrollment in the first stage of its NORTH two-stage Phase II trial.
MeadWestvaco Corporation (NYSE: MWV), a global leader in packaging and packaging solutions, will discuss preservative-free medication dispensing at Pharmapack Europe, Paris, on 14 February at 09:55 CET.
The Medicines Company (NASDAQ: MDCO) has scheduled its quarterly conference call for Wednesday, February 20 at 8:30 a.m. Eastern Time to discuss fourth quarter and full year 2012 financial results, operational developments, and outlook for 2013.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Peter N. Kellogg, executive vice president and chief financial officer, Merck, is scheduled to present at the Leerink Swann 2013 Global Healthcare Conference in New York on February 13 at 11:30 a.m. EST.
mPhase Technologies, Inc. (OTCBB: XDSL) said today that it has filed a United States Letter Patent application for a novel drug delivery system based on its Smart Surface technology.
OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today announced plans for the initiation of the Borealis-2 clinical trial, an investigator-sponsored, randomized, controlled Phase 2 study evaluating OGX-427 in patients with advanced or metastatic bladder cancer who have disease progression following initial platinum-based chemotherapy treatment.
Oragenics, Inc. (OTCBB: OGEN) announced today that its Exclusive Channel Collaboration (ECC) with Intrexon Corporation, a synthetic biology company, has produced an exponential increase in the fermentation titer of the target compound MU1140 and the discovery of a promising new purification process for this product.
Quantum Materials Corporation (QMC) (OTCQB:QTMM) announces a new class of cadmium-free, non-REE, non-heavy metal tetrapod quantum dots (NHM-TPQD) developed to meet worldwide concerns regarding nanoparticle biocompatibility and sustainability.
Quidel Corporation (NASDAQ: QDEL), a leading provider of rapid diagnostic testing solutions and cellular-based virology assays, announced today financial results for the fourth quarter and full year ended December 31, 2012.
RQx Pharmaceuticals, Inc. today announced that it has entered into a drug discovery collaboration with Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), for the discovery and development of novel drug compounds for an undisclosed target.
Sigma-Aldrich® Corporation (NASDAQ: SIAL), a leading Life Science and High Technology Company, announced that Sigma® Life Science, its innovative biological products and services business, signed an agreement to distribute worldwide Olink Bioscience's Duolink® In Situ products, which present a new disruptive method for imaging and measuring protein-protein interactions in unmodified cells.
Sirona Biochem Corp. (TSX VENTURE:SBM) (OTCQX:SRBCF) (FRANKFURT:ZSB) announced today its skin lightening compounds, TFC-849 and TFC-723, were proven to be safe in an ocular tolerability study.
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced it will host a teleconference and webcast with management to discuss the fourth quarter and fiscal year 2012 financial results, provide an update on the Company's business, and discuss expectations for the future.
Targeted Medical Pharma, Inc. (OTCQB: TRGM) (OTCBB: TRGM), a biotechnology company that develops and distributes prescription medical foods to physicians and pharmacies, today announced it has been issued patent number 8370172 from the United States Patent and Trademark Office.
Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA), a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders, today announced financial and operational results for the fourth quarter and full year ended December 31, 2012.
DNDN New PROVENGE® (sipuleucel-T) Data to Be Presented at 2013 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium
-- Two studies examine potential for PROVENGE in combination or sequenced with two approved advanced prostate cancer therapies
-- Additional retrospective study data suggest that relative to placebo, PROVENGE may delay time to first opioid use for pain in patients with advanced prostate cancer
-- Preliminary data on NeuACT study for high-risk urothelial carcinoma show high frequency of HER2 expression at primary tumor and lymph node samples
Symbol Price Change
DNDN 6.54
BRIDGEWATER, N.J.--(BUSINESS WIRE)--
February 13, 2013--Dendreon Corporation (NASDAQ: DNDN) today announced that results from several ongoing or completed studies investigating the utility of PROVENGE® (sipuleucel-T) in the treatment of advanced prostate cancer, including studies that may lead to new treatment approaches, as well as the investigational immunotherapy DN24-02 in patients with surgically-resected urothelial cancer, will be presented at the 2013 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium in Orlando, Florida, from February 14-16, 2013.
“This year’s ASCO GU meeting is important for Dendreon because of the wide range of studies being presented that help us better understand PROVENGE,” said Mark Frohlich, M.D., executive vice president of research and development and chief medical officer at Dendreon. “The studies that inform us about the potential use of PROVENGE in combination or sequenced with other advanced prostate cancer treatments are encouraging, and we look forward to additional data from these studies.”
Data presented include and can be accessed via the following links:
Abstract #34: Randomized Phase II Trial Evaluating the Optimal Sequencing of Sipuleucel-T and Androgen Deprivation Therapy (ADT) in Patients with Biochemically-Recurrent Prostate Cancer (BRPC): A Phase II sequencing study evaluating PROVENGE followed by ADT or ADT followed by PROVENGE in men with biochemically-recurrent prostate cancer showed a prime-boost immune response effect based on antigen presenting cell activation patterns, and an analysis of serum samples indicated that there were no differences between the arms in cellular or humoral immune responses. Adverse events for each treatment were consistent with what was seen in pivotal trials.
Abstract #114: A Randomized Phase II, Open-Label Study of Sipuleucel-T with Concurrent or Sequential Abiraterone Acetate (AA) in Metastatic Castrate-Resistant Prostate Cancer (mCRPC): A Phase II study evaluating concurrent or sequential therapy with AA plus prednisone (P) in men with metastatic castrate resistant prostate cancer demonstrated no significant differences in median cumulative CD54 upregulation (31.6 vs. 36.6), or the measure of antigen presenting cell activation, and CD54+ count (1.9 vs. 2.1x109) between the two arms, suggesting that PROVENGE can be manufactured during treatment with AA + P therapy. Adverse events for each treatment were consistent with what was seen in pivotal trials.
Abstract #74: Sipuleucel-T Appears to Delay Time to First Use of Opioid Analgesics (TFOA) in Patients with Asymptomatic or Minimally Symptomatic Metastatic Castration Resistant Prostate Cancer (mCRPC) on the IMPACT Trial: A retrospective analysis of a subset of the IMPACT trial demonstrated that relative to placebo, treatment with PROVENGE appeared to delay the first use of opioid analgesics for pain associated with advanced prostate cancer. Opioid therapy is currently recommended by the World Health Organization (WHO) for moderate to severe pain associated with cancer. In patients with advanced cancer, pain is described as moderate to severe in approximately 40-50 percent and very severe or excruciating in 25-30 percent of cases.1
Abstract #292: HER2 Expression in Patients with Surgically Resected Urothelial Cancer at High Risk of Recurrence Screened for the Phase II Randomized, Open-Label Trial of DN24-02, an Autologous Cellular Immunotherapy Targeting HER2: In the NeuACT study, Dendreon’s investigational DN24-02 is being studied in urothelial carcinoma. Preliminary data presented show a high frequency (>80 percent) of HER2 expression score of >1+ found in primary tumor and lymph node samples of patients with high-risk urothelial carcinoma, as is consistent with previously published data.
“These preliminary PROVENGE data are promising for the treatment of metastatic castrate resistant prostate cancer," said Eric Small, M.D., Chief of the Division of Hematology and Oncology, and Deputy Director, UCSF Helen Diller Family Comprehensive Cancer Center. “The medical community is particularly excited about the studies investigating the potential for treatment with PROVENGE and other currently approved treatments for advanced prostate cancer, which may provide us with new therapeutic approaches to help men fight this disease in the future.”
Additional Dendreon abstracts accepted for presentation at the meeting can be accessed via the following links:
Abstract #148: Immune Response with Sipuleucel-T in Patients with Metastatic Castrate-Resistant Prostate Cancer (mCRPC): Phase II PROACT Study
Abstract #147: P10-1 Open Label, Multicenter Study of Sipuleucel-T in Metastatic Castrate-Resistant Prostate Cancer (mCRPC) Patients Previously Treated with Sipuleucel-T: Evaluation of Antigen Presenting Cell (APC) Activation
Abstract #131: Real-World Experience with Sipuleucel-T in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients >80 Years Old: Data from PROCEED
Abstract #30: Real-World Experience with Sipuleucel-T in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Received Prior Docetaxel (D): Data from PROCEED
About PROVENGE
Indication and Important Safety Information
PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.
The safety evaluation of PROVENGE was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis. The most common adverse events (incidence greater-than or equal to 15%) are chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events reported in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.
To fulfill a post marketing requirement and as a part of the company's ongoing commitment to patients, Dendreon will conduct a registry of approximately 1500 patients to further evaluate a small potential safety signal of cerebrovascular events. In four randomized clinical trials of PROVENGE in prostate cancer patients, cerebrovascular events were observed in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group.
For the FDA approved full prescribing information, please visit http://www.provenge.com.
About Dendreon
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development, commercialization and manufacturing of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy (ACI) product candidates designed to stimulate an immune response in a variety of tumor types. Dendreon's first product, PROVENGE® (sipuleucel-T), was approved by the FDA in April 2010. Dendreon is exploring the application of additional ACI product candidates and small molecules for the potential treatment of a variety of cancers. The Company is headquartered in Seattle, Washington and is traded on the NASDAQ Global Market under the symbol DNDN. For more information about the Company and its programs, visit http://www.dendreon.com.
Statements in this press release that are not strictly historical in nature constitute “forward-looking statements.” Such statements include, but are not limited to, statements regarding the expected benefits of the restructuring, the timing and elements of the restructuring, the timing and form of related charges, the expected annual operating expense reduction, expectations and beliefs regarding Dendreon’s profitability and Dendreon’s ability to achieve improved performance as a result of the restructuring, expectations regarding regulatory approval of PROVENGE® in Europe, expectations regarding the presentation of clinical data, developments affecting Dendreon's U.S. and global business and prospects and potential revenue and earnings from product sales, expectations regarding market size and market opportunity, and progress generally on commercialization efforts for PROVENGE. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause Dendreon’s actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, our inability to achieve and sustain commercial success for PROVENGE; the identification of efficacy, safety or other issues with PROVENGE; a slower than anticipated adoption by treating physicians of PROVENGE for the treatment of patients with advanced prostate cancer due to competing therapies, perceived difficulties in the treatment process, delays in obtaining reimbursement or for other reasons; any promotional limitations imposed by the FDA on our ability to commercialize and market PROVENGE; unexpected difficulties and costs associated with the rapid expansion of our operations to support the commercial launch of PROVENGE; and other factors discussed in the “Risk Factors” section of Dendreon’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2012. All forward-looking statements are qualified in their entirety by this cautionary statement. Dendreon is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.
Coyle N, Adelhardt J, Foley KM, Portenoy RK. Character of terminal illness in the advanced cancer patient: pain and other symptoms during the last four weeks of life. J Pain Symptom Manage 1990;5:83–93.
Contact:
Dendreon Corporation
Corporate Communications
Lindsay Rocco, 862-596-1304
media@dendreon.com
or
Joele Frank, Wilkinson Brimmer Katcher
Investor Relations
Andrea Rose, 212-355-4449
InvestorRelations@dendreon.com
FOLD Presents Additional Results From Phase 2 Chaperone-Enzyme Replacement Therapy (ERT) Study for Fabry Disease at LDN World Symposium
Migalastat HCl Co-Administered With ERT Increased Fabry Enzyme (Alpha-Gal A) Levels
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Symbol Price Change
FOLD 4.03
CRANBURY, N.J. and ORLANDO, Fla., Feb. 13, 2013 (GLOBE NEWSWIRE) -- Amicus Therapeutics (FOLD), today announced further results from an open-label Phase 2 drug-drug interaction study (Study 013) to evaluate a single oral dose of migalastat HCl (150 mg or 450 mg) co-administered prior to enzyme replacement therapy (ERT) in males with Fabry disease. Preliminary results were announced during 2012. Results for the migalastat HCl 450 mg dose group are being presented for the first time in a poster1 at the Lysosomal Disease Network WORLD Symposium (LDN WORLD).
Dr. David G. Warnock, University of Alabama-Birmingham, stated, "When co-administered with ERT, both doses of migalastat HCl appeared to increase enzyme activity compared to Fabrazyme and Replagal alone in this study. We believe that these results support further clinical studies in Fabry patients to investigate the use of a pharmacological chaperone to maintain infused alpha Gal-A enzymes in optimally active form through this chaperone-ERT combination approach."
Amicus, in collaboration with GlaxoSmithKline (GSK), is developing the investigational pharmacological chaperone migalastat HCl as a monotherapy and in combination with ERT for the treatment of Fabry disease. When co-administered with ERT, migalastat HCl binds to and stabilizes infused enzyme in the circulation.
Migalastat HCl (150 mg and 450 mg) Co-Administered with ERT (Fabrazyme and Replagal)
Each patient in Study 013 received their current dose and regimen of ERT (Fabrazyme(R) or Replagal(R), infused alpha-Gal A enzymes) at one infusion. A single oral dose of migalastat HCl (150 mg or 450 mg) was co-administered 2 hours prior to the next infusion of the same ERT at the same dose and regimen. Among 20 total males who enrolled, 3 opted to participate in the migalastat 150 mg and then again in the 450 mg treatment arms.
Safety: finalized safety data are expected in 2Q13. As currently evaluated, 2 serious adverse events (SAEs) occurred in one patient (transient ischemic attack and hospitalization for acute pain and acroparesthesia due to Fabry disease) and were considered by the investigator to be unrelated to migalastat HCl when co-administered with ERT. Of the remaining treatment emergent adverse events the majority were unrelated to study drug.
Active enzyme in plasma: active alpha-Gal A enzyme levels were measured in plasma (total area under the curve, or AUC) during and after each infusion. Following co-administration, active enzyme levels in plasma increased in 22 out of 23 instances and were unchanged in 1 instance compared to ERT alone. These PK results demonstrated a drug-drug interaction between both doses of migalastat HCl and both ERTs.
Enzyme uptake into skin: alpha-Gal A enzyme levels were also measured in skin following each infusion. Increased levels of alpha-Gal A enzyme measured in skin biopsy samples on day 2 and, to a lesser extent, on day 7, showed increased enzyme uptake into tissue compared to ERT alone. This exploratory assessment showed that the greatest increases in active alpha-Gal A enzyme levels were observed following migalastat HCl 450 mg co-administered with ERT.
Alpha-Gal A Levels of Active Enzyme
Mean-Fold Increase in
Plasma Area Under
Curve (AUC) vs. ERT
Alone (Range) Mean-Fold
Increase in Skin
at Day 2 vs. ERT
Alone (Range) Mean-Fold
Increase in Skin
at Day 7 vs. ERT
Alone (Range)
Migalastat HCl 150 mg + Replagal 0.2 mg/kg (n = 4) 4.3 (3.2 to 5.0) 1.8 (1.4 to 2.3) 1.4 (1.1 to 1.8)
Migalastat HCl 150 mg + Fabrazyme 0.5 mg/kg (n = 5)* 3.0 (2.0 to 4.2) 2.6 (1.1 to 3.9) 1.4 (0.7 to 2.8)
Migalastat HCl 150 mg + Fabrazyme 1.0 mg/kg (n = 3) 2.0 (1.6 to 2.2) 1.9 (1.6 to 2.1) 1.4 (1.2 to 1.7)
Migalastat HCl 450 mg + Replagal 0.2 mg/kg (n = 4) 3.1 (2.3 to 5.0) 2.3 (1.6 to 3.7) 2.1 (1.0 to 2.8)
Migalastat HCl 450 mg + Fabrazyme 0.5 mg/kg (n = 1)* 2.4 3.7 1.9
Migalastat HCl 450 mg + Fabrazyme 1.0 mg/kg (n = 6) 2.0 (1.0 to 3.2) 1.8 (1.0 to 2.5) 1.5 (0.6 to 3.3)
* Due to Fabrazyme supply difficulties during enrollment, subjects had been receiving 0.5 mg/kg Fabrazyme infused every two weeks
John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics said, "Study 013 was the first clinical study to investigate the chaperone-ERT combination approach. This study has been a major catalyst for our further development of chaperone-ERT combinations across the lysosomal storage diseases, including chaperones co-administered with marketed ERTs as well as proprietary chaperone-ERT co-formulated products in preclinical development as next-generation ERTs."
In addition to chaperone-ERT co-administration in Fabry disease, Amicus and GSK are developing migalastat HCl co-formulated with JCR Pharmaceutical Co. Ltd's proprietary investigational ERT (JR-051, recombinant human alpha-Gal A enzyme). This chaperone-ERT co-formulated product has the potential to enter the clinic in late-2013 or early 2014.
Conference Call and Webcast
John F. Crowley, Chairman and Chief Executive Officer, and members of the Amicus executive team will host a conference call and live audio/visual webcast on Friday, February 15, 2013 at 11:30am ET to discuss the data from several programs presented at LDN WORLD. Interested participants and investors may access the conference call at 11:30 a.m. ET by dialing 877-303-5859 (U.S./Canada) or 678-224-7784 (international). A live audio webcast can also be accessed via the Investors section of the Amicus Therapeutics corporate web site at http://ir.amicustherapeutics.com/events.cfm, and will be archived for 30 days. The slide presentation for the conference call/webcast will also be available at http://ir.amicustherapeutics.com/events.cfm. Web participants are encouraged to go to the web site 15 minutes prior to the start of the call to register, download and install any necessary software. A telephonic replay of the call will be available for seven days beginning at 2:30 p.m. ET on February 15, 2013. Access numbers for this replay are 855-859-2056 (U.S./Canada) and 404-537-3406 (international); participant code 97505816.
About Amicus Therapeutics
Amicus Therapeutics (FOLD) is a biopharmaceutical company at the forefront of therapies for rare and orphan diseases. The Company is developing orally-administered, small molecule drugs called pharmacological chaperones, a novel, first-in-class approach to treating a broad range of human genetic diseases. Amicus' late-stage programs for lysosomal storage disorders include migalastat HCl monotherapy in Phase 3 for Fabry disease; migalastat HCl co-administered with enzyme replacement therapy (ERT) in Phase 2 for Fabry disease; and AT2220 co-administered with ERT in Phase 2 for Pompe disease.
About Migalastat HCl
Amicus in collaboration with GlaxoSmithKline (GSK) is developing the investigational pharmacological chaperone migalastat HCl for the treatment of Fabry disease. Amicus has commercial rights to all Fabry products in the United States and GSK has commercial rights to all of these products in the rest of world.
As a monotherapy, migalastat HCl is designed to bind to and stabilize, or "chaperone" a patient's own alpha-galactosidase A (alpha-Gal A) enzyme in patients with genetic mutations that are amenable to this chaperone in a cell-based assay. Migalastat HCl monotherapy is in Phase 3 development (Study 011 and Study 012) for Fabry patients with genetic mutations that are amenable to this chaperone monotherapy in a cell-based assay. Study 011 is a placebo-controlled study intended primarily to support U.S. registration, and Study 012 compares migalastat HCl to ERT to primarily support global registration.
For patients currently receiving ERT for Fabry disease, migalastat HCl in combination with ERT may improve ERT outcomes by keeping the infused alpha-Gal A enzyme in its properly folded and active form thereby allowing more active enzyme to reach tissues.2 Migalastat HCl co-administered with ERT is in Phase 2 (Study 013) and migalastat HCl co-formulated with JCR Pharmaceutical Co. Ltd's proprietary investigational ERT (JR-051, recombinant human alpha-Gal A enzyme) is in preclinical development.
About Fabry Disease
Fabry disease is an inherited lysosomal storage disorder caused by deficiency of an enzyme called alpha-galactosidase A (alpha-Gal A). The role of alpha-Gal A within the body is to break down specific lipids in lysosomes, including globotriaosylceramide (GL-3, also known as Gb3). Lipids that can be degraded by the action of a-Gal are called "substrates" of the enzyme. Reduced or absent levels of alpha-Gal A activity leads to the accumulation of GL-3 in the affected tissues, including the kidneys, heart, central nervous system, and skin. This accumulation of GL-3 is believed to cause the various symptoms of Fabry disease, including pain, kidney failure, and increased risk of heart attack and stroke.
It is currently estimated that Fabry disease affects approximately 5,000 to 10,000 people worldwide. However, several literature reports suggest that Fabry disease may be significantly under diagnosed, and the prevalence of the disease may be much higher.
1. Bichet, et al., A Phase 2a Study to Investigate the Effect of a Single Dose of Migalastat HCl, a Pharmacological Chaperone, on Agalsidase Activity in Subjects with Fabry Disease, LDN WORLD 2012
2. Benjamin, et al., Molecular Therapy: April 2012, Vol. 20, No. 4, pp. 717--726.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to clinical development of Amicus' candidate drug products and the timing and reporting of results from clinical trials evaluating Amicus' candidate drug products. Words such as, but not limited to, "look forward to," "believe," "expect," "anticipate," "estimate," "intend," "plan," "targets," "likely," "will," "may," "would," "should" and "could," and similar expressions or words identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. The inclusion of forward-looking statements should not be regarded as a representation by Amicus that any of its plans will be achieved. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions Amicus might make or by known or unknown risks and uncertainties. For example, with respect to statements regarding the goals, progress, timing and outcomes of discussions with regulatory authorities and the potential goals, progress, timing and results of clinical trials, actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in the business of Amicus, including, without limitation: the potential that results of clinical or pre-clinical studies indicate that the product candidates are unsafe or ineffective; the potential that it may be difficult to enroll patients in our clinical trials; the potential that regulatory authorities may not grant or may delay approval for our product candidates; the potential that preclinical and clinical studies could be delayed because we identify serious side effects or other safety issues; the potential that we will need additional funding to complete all of our studies and, our dependence on third parties in the conduct of our clinical studies. Further, the results of earlier preclinical studies and/or clinical trials may not be predictive of future results. In addition, all forward looking statements are subject to other risks detailed in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2012. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Amicus undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
FOLD--G
Contact:
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PCYC -Pharmacyclics receives Breakthrough Therapy Designation from the FDA to the investigational oral agent ibrutinib monotherapy (PCYC) 70.37 : Co announces that the FDA granted Breakthrough Therapy Designation to the investigational oral agent ibrutinib monotherapy for the treatment of patients with relapsed or refractory mantle cell lymphoma and to ibrutinib monotherapy for the treatment of patients with Waldenstrom's macroglobulinemia, both of which are B-cell malignancies. Pharmacylics, together with Janssen, a JNJ unit is working with the FDA to determine the implications of this Breakthrough Therapy Designation to the ongoing and planned development and the filing requirements for the use of ibrutinib in patients with MCL and WM. The co expects to finalize the MCL filing prior to year end and will provide guidance on the WM filing after further discussions with the FDA.
Medivation and Astellas Pharma (ALPMY.PK) announce data for enzalutamide will be presented at ASCO GU Symposium; Phase 2 study showed 93% of study participants experienced a 80% PSA decrease at week 25 (MDVN) 54.01 : Six abstracts presented include data from Phase 2 study inestigating XTANDI (enzalutamide) capsules in hormone-naive prostate cancer.
The Phase 2 study assessed the efficacy and safety of enzalutamide monotherapy (160 mg) in 67 patients who had never received hormone therapy and presented with normal testosterone levels (=230 ng/dL). The analysis showed 93% of study participants experienced a =80% PSA decrease at week 25; Median change in PSA was -99.6% (range -100% to -86.5%).
A phase I study of enzalutamide given in combination with docetaxel in men with metastatic castration-resistant prostate cancer (mCRPC) who are on androgen deprivation therapy is currently ongoing. Preliminary data suggest that enzalutamide does not affect tolerability of docetaxel or have a clinically meaningful impact on docetaxel pharmacokinetics in this patient population. Overall, enzalutamide was well tolerated with no patients discontinuing because of an enzalutamide-related adverse event.
A post-hoc analysis of AFFIRM, a randomized, multinational, placebo-controlled phase 3 study among patients with mCRPC who had previously received docetaxel, showed that concomitant corticosteroid (CS) use was associated with reduced overall survival (median of 12.8 months in the CS group vs. median not met in the no CS group) and higher rates of grade 3-4 adverse events (63.3% in the CS group vs. 34.4% in the no CS group) in this population.
An analysis of patients enrolled in the enzalutamide phase 3 AFFIRM study showed that a greater percentage of patients on enzalutamide reported health-related quality of life (HRQoL) improvement compared to placebo (42.2% vs. 14.5%; p < 0.001).
GTXI -GTX announces new data from two Phase II studies on the effects of Capesaris (GTx-758) for the treatment of advanced prostate cancer to be presented at 2013 ASCO GU Symposium; GTx-758 significantly reduced free testosterone and PSA levels in Phase II studies (GTXI) 4.84 : In two Phase II clinical studies in men with advanced prostate cancer, patients receiving either 1000 mg or 2000 mg daily doses of GTx-758 demonstrated significant reductions in their serum free (unbound) testosterone (T) levels, with related reductions in their levels of serum prostatic specific antigen (PSA). The effects of GTx-758 and leuprolide on hot flashes, a common side effect in men on ADT, were assessed in 99 evaluable patients (of a total of 159 newly diagnosed patients with advanced prostate cancer) who reached 90 days of treatment. While baseline data showed no significant differences in the number of men reporting hot flashes in any of the treatment groups, the percentage of men experiencing a hot flash while receiving leuprolide increased significantly to 60.4% by day 28, and further increased to 80.9% by day 90.... GTx is currently conducting a Phase II clinical trial (G200712) to evaluate the safety and effectiveness of lower doses of GTx-758 to treat men with metastatic castration resistant prostate cancer. Seventy-five men with metastatic castration resistant prostate cancer will be randomized into one of three cohorts to receive a 125 mg, 250 mg or 500 mg daily dose of GTx-758. Each arm will have 25 subjects, and the enrollment will be conducted sequentially, with the 125 mg cohort currently being enrolled.
PLX -Protalix BioTherapeutics announces new clinical data on ELELYSO to be presented at the WORLD Symposium 2013; data 'further reinforce the use of ELELYSO as a treatment option for Gaucher patients, including naive Gaucher patients, and patients who were previously treated with imiglucerase' (PLX) 5.73 : Co announced today that new clinical data on ELELYSO will be presented at the 9th Annual Meeting of the Lysosomal Disease Network: WORLD Symposium 2013 being held February 13-15 in Orlando, Florida. ELELYSO, the Company's first commercial product, is the first FDA-approved plant cell-based enzyme replacement therapy for Gaucher disease. A 24 month interim analysis of the switchover trial demonstrates that all patients remained stable with regard to all key disease parameters, spleen volume, liver volume, platelet count and hemoglobin concentration, as well as the chitotriosidase activity biomarker after switching to ELELYSO from imiglucerase. The safety analysis presented for the 24-month switchover treatment duration demonstrates that ELELYSO was well tolerated, and no drug related serious adverse events were reported. One patient developed neutralizing IgG antibodies that were determined to be positive in an in vitro assay, and were determined to be negative in a cell-based assay.
The safety analysis presented for both treatment groups demonstrates that ELELYSO was well tolerated, and no drug related serious adverse events were reported. Two participants developed neutralizing IgG antibodies that were determined to be positive in an in vitro assay, and were determined to be negative in a cell-based assay. In addition, one patient in the 60 U/kg dose group experienced a hypersensitivity reaction during month 10 of treatment.
PATH -PROLOR Biotech's longer-acting human growth hormone receives orphan drug designation in Europe (PBTH) 4.99 : Co announced that the European Commission and the European Medicines Agency (EMA) have granted orphan drug designation to hGH-CTP, PROLOR's longer-acting version of human growth hormone in development for the treatment of growth hormone deficiency. PROLOR will receive 10 years of marketing exclusivity in Europe for hGH-CTP, beginning at product launch. This is the first time a growth hormone product has received orphan drug designation in Europe.
"In Phase II studies in growth hormone-deficient adults, hGH-CTP was safe and well tolerated, and it demonstrated the potential to be administered once-weekly, replacing seven daily injections of currently marketed human growth hormone. These results enabled PROLOR to initiate a Phase II trial in children with growth hormone deficiency and to proceed with plans for a Phase III trial in growth hormone-deficient adults, which is scheduled to begin later this year."
IBIO -iBio receives approval from NYSE MKT of compliance plan (IBIO) 0.69 : In connection with accepting the Company's compliance plan, the Exchange has granted the Company an extension until October 14, 2013 to regain compliance with the $6,000,000 stockholders' equity requirement.
ISCO Demonstrates Positive Animal Efficacy Results in Metabolic Liver Disease Program
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ISCO 0.39
CARLSBAD, CA--(Marketwire - Feb 12, 2013) - International Stem Cell Corporation ( OTCQB : ISCO ) (www.internationalstemcell.com) ("ISCO" or "the Company") a California-based biotechnology company, today announced the conclusions from its study demonstrating the efficacy and safety of the hepatocyte-like cells (HLC) derived from human parthenogenetic stem cells (hpSC) in a well-established animal model of a congenital liver disorder associated with bilirubin metabolism. The data from this pre-clinical study indicates that implanting HLC in rodents produced both a significant initial decrease and the long-term stabilization of bilirubin levels in blood serum.
Criggler-Najjar syndrome type 1 (CN1) is a rare inherited metabolic disorder in which the sufferer's liver lacks a specific enzyme -- UGT1A1, which is essential for the clearance of the toxin bilirubin. The syndrome results in unconjugated hyperbilirubinemia, a disorder characterized by severe neurological complications which, if left untreated, can lead to irreversible acute encephalopathy. Allogenic hepatocyte transplantation (HT) has been used as an alternative therapeutic option for patients with liver-based metabolic diseases including CN1. However, one of the major factors limiting the clinical advancement of human HT is a shortage of mature, functioning human hepatocytes as well as the limited repopulation capacity of grafted adult cells.
The use of HLCs to treat CN1 has several potential advantages over transplantation of primary hepatocytes. Firstly, HLC would circumvent the shortage of primary cells, as they can be produced and expanded in vitro. Secondly, there is evidence to suggest that grafting HLC may yield better long-term repopulation and persistent metabolic activity than using immature fetal hepatocytes. HLCs can also be given before the onset of bilirubin encephalopathy occurs, and can thus provide sufficient amounts of UGT1A1 to allow the liver to metabolize this toxin.
ISCO has previously reported how these HLC engraft in the liver of Gunn rats, a well-validated model of CN1 where the animals lack UGT1A1 and therefore accumulate toxic levels of unconjugated bilirubin. In addition to this result, no adverse safety signals were detected 16 weeks after the implantation of a therapeutic dose of HLC, and serum levels of bilirubin continued to decline, compared with the control group, up to the conclusion of the observation period at week 19. Moreover, the overall structure and morphology of the liver in all rodents in the treatment group appeared to be undamaged, with no apparent inflammation, tumorigenicity or cell rejection observed.
Dr. Ruslan Semechkin, Vice President - head of R&D for ISCO comments: "This study provides important evidence for the use of our HLC product as a viable source of transplantable cells for the treatment of CN1. Having completed this study, we can now discuss with the FDA the requirements for our Investigational New Drug (IND) application and phase 1 clinical trial."
About International Stem Cell Corporation
International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs) hence avoiding ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.
To receive ongoing corporate communications via email, visit: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0
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Safe harbor statement
Statements pertaining to anticipated developments, the potential use of technologies to develop therapeutic products and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects" or "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products and the management of collaborations, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.
Contact:
International Stem Cell Corporation
Dr. Simon Craw
Executive Vice President
Phone: 760-940-6383
Email: ir@intlstemcell.com
Dr. Ruslan Semechkin
Vice President, R&D
Phone: 760-940-6383
Email: ras@intlstemcell.com
Investor Relations:
MZ Group
Mark McPartland
Senior Vice President
Phone: 212-301-7130
Email: markmcp@mzgroup.us
Web: www.mzgroup.com
OGEN Announces Significant Progress Towards Commercial Production of Lead Lantibiotic MU1140
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OGEN 3.50
TAMPA, Fla.--(BUSINESS WIRE)--
Oragenics, Inc. (OGEN) announced today that its Exclusive Channel Collaboration (ECC) with Intrexon Corporation, a synthetic biology company, has produced an exponential increase in the fermentation titer of the target compound MU1140 and the discovery of a promising new purification process for this product. This demonstrates significant progress toward the commercial production of its lead lantibiotic, MU1140, and delivers an important step in validating the lantibiotics platform targeting infectious diseases. Oragenics and Intrexon have been working together through the ECC to produce a pipeline of new lantibiotics that have been shown to be active against essentially all Gram-positive pathogens, including vancomycin-resistant enterococci (VRE), Clostridium difficile, methicillin-resistant Staphylococcus aureus (MRSA), as well as multi-drug resistant strains of Mycobacterium tuberculosis.
"The ability to manufacture MU1140 by fermentation was originally thought not to be commercially feasible due to low titers and difficulties in purification. The Oragenics-Intrexon ECC clearly shows that the application of specific expertise in these areas represents a breakthrough by developing a potentially viable commercial process for these important anti-infective agents," stated Dr. John N. Bonfiglio, Chief Executive Officer of Oragenics. In addition to the optimization of fermentation and purification strategies, Oragenics and Intrexon are working to leverage Intrexon’s genetic and cell engineering expertise to produce analogs of MU1140 and a pipeline of new lantibiotics. “We believe the newly developed process will provide for the first time, the necessary quantities of MU1140 to complete critical development activities,” added Dr. Bonfiglio.
About Oragenics, Inc.
Oragenics, Inc. is focused on becoming the world leader in novel antibiotics against infectious disease and probiotics for oral health for humans and pets. Oragenics, Inc. has established an exclusive worldwide channel collaboration for lantibiotics, a novel class of broad spectrum antibiotics, with Intrexon Corporation Inc., a synthetic biology company. The collaboration will allow Oragenics access to Intrexon's proprietary technologies with the idea of accelerating the development of much needed new antibiotics that will work against resistant strains of bacteria. Oragenics also develops, markets and sells proprietary probiotics specifically designed to enhance oral health for humans and pets, under the brand names Evora and ProBiora in over 13 countries worldwide.
For more information about Oragenics, visit www.oragenics.com. Follow Oragenics on Facebook and Twitter.
Safe Harbor Statement: Under the Private Securities Litigation Reform Act of 1995: This release includes forward-looking statements that reflect the Company’s current views with respect to future events and financial performance. These forward-looking statements are based on management’s beliefs and assumptions and information currently available. The words “believe,” “expect,” “anticipate,” “intend,” “estimate,” “project” and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to our ability to raise additional capital to sustain our operations beyond June 30, 2012 and those set forth in our most recently filed annual report on Form 10-K and quarterly report on Form 10-Q, and other factors detailed from time to time in filings with the U.S. Securities and Exchange Commission. We expressly disclaim any responsibility to update forward-looking statements.
Contact:
Oragenics, Inc.
Michael Sullivan, 813-286-7900, ext. 246
Chief Financial Officer
Direct: 813-786-6431
msullivan@oragenics.com
CEMP -Grant Awarded to Study Novel Therapies for Muco-Obstructive Diseases Includes Studies on Cempra's Solithromycin (CEM-101) in a Cystic Fibrosis Anti-inflammatory Model
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CEMP 6.53
CHAPEL HILL, N.C., Feb. 12, 2013 /PRNewswire/ -- Cempra, Inc. (CEMP), a clinical-stage pharmaceutical company focused on developing differentiated antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced that the National Institute of Allergy and Infectious Diseases (NIAID) awarded a grant to Richard C. Boucher, M.D., Kenan Professor of Medicine and director of the Cystic Fibrosis and Pulmonary Research and Treatment Center at the University of North Carolina School of Medicine, to investigate the anti-inflammatory activity of solithromycin and its effect on mucin secretion in models for cystic fibrosis (CF).
Dr. Boucher's laboratory has studied the role of mucin secretion as well as sodium transport by respiratory epithelium. His laboratory has also investigated the anti-inflammatory activity of and inhibition of mucin production by azithromycin, a first-generation macrolide antibiotic. Solithromycin has demonstrated greater potency than azithromycin and other antibiotics against respiratory pathogens as well as stronger anti-inflammatory properties in vitro and in animal models. Dr. Boucher's grant, entitled "Novel Therapies for Muco-Obstructive Lung Diseases," will include tests of solithromycin for its effect on mucus production and for its anti-inflammatory effects in models for CF.
"Treatment of cystic fibrosis patients is complicated by the secretion of excessive mucin, which can trap bacteria, as well as promote airway inflammation, said Dr. Boucher. "Our research is directed toward identifying compounds that can inhibit mucin formation, reduce inflammation and restore normal airways physiology. Macrolides, such as azithromycin, have been used to manage these processes in CF patients in the past. Solithromycin is one of the promising new agents in development, because of its potent anti-inflammatory and anti-mucin activity, that could become an important option for physicians managing CF patients."
Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra said, "Solithromycin is emerging as a truly differentiated antibiotic that may become an important option for physicians to treat serious infections such as community-acquired bacterial pneumonia (CABP) or gonococcal infections. Solithromycin has demonstrated a broad activity spectrum, including against macrolide-resistant strains, in in vitro and in vivo models. In a Phase 2 trial of patients with gonorrhea, all patients were cured with a single dose of solithromycin. We have recently initiated a Phase 3 trial of oral solithromycin in CABP patients, which could result in the only macrolide being available as oral monotherapy to treat the disease. An intravenous (IV) formulation is also in development and we plan to start an IV-to-oral trial in CABP in the second half of 2013. The two dosing options would enable patients to step down from IV to oral therapy and presumably leave the hospital sooner while staying on the same antibiotic. Dr. Boucher's research highlights another property of the compound, its anti-inflammatory and anti-mucin production activity. We look forward to seeing the results of his work."
About Cempra, Inc.
Founded in 2006, Cempra, Inc. is a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases. Cempra's two lead product candidates are in advanced clinical development; solithromycin in Phase 3 for CABP and CEM-102 for prosthetic joint infections. Both seek to address the need for new treatments targeting drug-resistant bacterial infections in the hospital and in the community. The company also intends to use its series of proprietary lead compounds from its novel macrolide library for uses such as the treatment of chronic inflammatory diseases, endocrine diseases and gastric motility disorders. Additional information about Cempra can be found at www.cempra.com.
Please Note: This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the results of studies of our product candidates conducted by others; the results, timing, costs and regulatory review of our studies and clinical trials; our need to obtain additional funding and our ability to obtain future funding on acceptable terms; our anticipated capital expenditures and our estimates regarding our capital requirements; our ability to obtain FDA approval of our product candidates; our dependence on the success of solithromycin and Taksta; and innovation by our competitors. The reader is referred to the documents that we file from time to time with the Securities and Exchange Commission.
Investor and Media Contacts:
Robert E. Flamm, Ph.D.
Russo Partners, LLC
(212) 845-4226
Robert.flamm@russopartnersllc.com
Andreas Marathovouniotis
Russo Partners LLC
(212) 845-4235
Andreas.marathis@russopartnersllc.com
OGXI Announces Plans for the Initiation of the Borealis-2 Clinical Trial Evaluating OGX-427 in Combination with Second-Line Therapy for Bladder Cancer
Company Reaffirms Commitment to Addressing Treatment Resistance in Genitourinary (GU) Cancers with Fourth Phase 2 GU trial in OGX-427 ORCA Program
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OGXI 11.79
BOTHELL, Wash. and VANCOUVER, British Columbia, Feb. 12, 2013 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (OGXI) today announced plans for the initiation of the Borealis-2 clinical trial, an investigator-sponsored, randomized, controlled Phase 2 study evaluating OGX-427 in patients with advanced or metastatic bladder cancer who have disease progression following initial platinum-based chemotherapy treatment. The trial, which is the fourth Phase 2 study of OGX-427 in a genitourinary (GU) cancer, will investigate if combining OGX-427 with docetaxel, a standard option in salvage treatment for metastatic bladder cancer, improves survival compared to docetaxel alone.
"Bladder cancer is often sensitive to chemotherapy in the first-line setting, but, when patients relapse, resistance to chemotherapy is frequent," stated Jonathan Rosenberg MD, Associate Physician, Memorial Sloan-Kettering Cancer Center and one of the primary investigators on the study. "This trial will evaluate the potential of OGX-427 to work synergistically with second- or third-line chemotherapy to overcome treatment resistance and prolong survival in patients with advanced bladder cancer."
Limited options exist for both the first- and second-line treatment of advanced bladder cancer. Currently, first-line platinum-based chemotherapy regimens result in a median overall survival of approximately 12-15 months. Docetaxel is commonly used in second-line treatment, with a reported median overall survival of approximately six months. Given acquired treatment resistance and these short survival times, there continues to be a high unmet need for additional therapeutic options for this patient population.
OGX-427 is designed to inhibit Heat Shock Protein 27 (HSP27), a cell-survival protein found at elevated levels in many human cancers including prostate, bladder, breast and non-small cell lung cancer. Overexpression of Hsp27 is thought to be an important factor leading to the development of treatment resistance and is associated with negative clinical outcomes in patients with various tumor types.
"The launch of Borealis-2 marks OncoGenex' continued commitment to expanding the OGX-427 clinical development program to better understand treatment resistance in GU cancers," said Scott Cormack, President and Chief Executive Officer of OncoGenex. "Given the growing incidence of bladder cancer due to an aging population, we believe there is an urgent need to identify new strategies to address treatment resistance and potentially improve outcomes in this patient population."
Borealis-2 will be the second randomized, controlled clinical trial of OGX-427 in advanced bladder cancer. The Borealis-1 clinical trial is the OncoGenex-sponsored, randomized, placebo-controlled Phase 2 study designed to evaluate a potential survival benefit, safety and tolerability of combining OGX-427 with gemcitabine and cisplatin in the first-line treatment of patients with advanced bladder cancer. If either Borealis trial shows a survival advantage, OncoGenex plans to initiate conversations with the Food and Drug Administration about the possibility of a Phase 3 study of OGX-427 in bladder cancer as part of the ORCA program.
About Borealis-2
The Borealis-2 clinical trial will randomize approximately 200 patients to receive either OGX-427 plus docetaxel treatment or docetaxel treatment alone. Patients may also continue weekly OGX-427 infusions as maintenance treatment until disease progression or unacceptable toxicity if they complete all 10 planned cycles of docetaxel or are discontinued from docetaxel due to docetaxel toxicity. The primary objective will be overall survival, with secondary objectives evaluating safety, tolerability, tumor response rates and the effect of therapy on Hsp27 levels and circulating tumor cells.
Borealis-2 will be conducted at approximately 30 sites in the U.S. and is being sponsored by the Hoosier Oncology Group. Dr. Noah Hahn from the Indiana University Simon Cancer Center, Dr. Toni Choueiri from the Dana-Farber Cancer Institute and Dr. Jonathan Rosenberg from Memorial Sloan-Kettering Cancer Center will serve as the primary investigators on the study.
ABOUT ORCA
The "ORCA" (Overcoming Resistance in CAncer) program encompasses the on-going studies of OGX-427 aiming to demonstrate that inhibition of Hsp27 can lead to improved prognosis and treatment outcomes for cancer patients. Phase 2 clinical trials are underway in prostate and bladder cancers, with additional studies expected to initiate this year. For more information on OGX-427 and ORCA, please visit www.oncogenex.com.
ABOUT ONCOGENEX
OncoGenex is a biopharmaceutical company committed to the development and commercialization of new therapies that address treatment resistance in cancer patients. OncoGenex has a diverse oncology pipeline, with each product candidate having a distinct mechanism of action and representing a unique opportunity for cancer drug development. OncoGenex and Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) have entered a global collaboration and license agreement to develop and commercialize OncoGenex' lead drug candidate, custirsen. Custirsen is currently in Phase 3 clinical development as a treatment in men with metastatic castrate-resistant prostate cancer and in patients with advanced, unresectable non-small cell lung cancer. OGX-427 is in Phase 2 clinical development and OGX-225 is currently in pre-clinical development. More information is available at www.OncoGenex.com.
OncoGenex' Forward Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements concerning our anticipated product development activities, such as expected clinical trial completion and design and statements regarding the potential benefits and potential development of our product candidates. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, including, among others, the risk that our product candidates will not demonstrate the hypothesized or expected benefits, the risk of delays in our expected clinical trials, the risk that new developments in the rapidly evolving cancer therapy landscape require changes in our clinical trial plans or limit the potential benefits of our product, the risk that our cash resources are insufficient to fund our planned activities for the time period expected and the other factors described in our risk factors set forth in our filings with the Securities and Exchange Commission from time to time, including the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.
STEM Announces First Patient Cohort Completes Spinal Cord Injury Trial - Gains in Sensory Function Persist 12 Months After Stem Cell Transplant
Improvement From Complete to Incomplete Injury Observed in One Patient
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STEM 1.645
NEWARK, Calif., Feb. 12, 2013 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced that the twelve-month data from the first patient cohort in the Company's Phase I/II clinical trial of its proprietary HuCNS-SC(R) product candidate (purified human neural stem cells) for chronic spinal cord injury continued to demonstrate a favorable safety profile, and showed that the considerable gains in sensory function observed in two of the three patients at the six-month assessment have persisted. The third patient remains stable. A summary of the data was presented today by Martin McGlynn, President and CEO, at the 15th Annual BIO CEO & Investor Conference. By completing the twelve-month assessment, the first patient cohort has now completed the trial, and has entered into a separate follow-up study for long-term observation.
"The multi-segment gains observed in sensory function in two patients at six months have endured at the 12-month assessment. In addition, between the six- and 12-month evaluations, one patient converted from a complete to an incomplete injury," said Armin Curt, M.D., Professor and Chairman of the Spinal Cord Injury Center at Balgrist University Hospital, University of Zurich and principal investigator of the clinical trial. "Importantly, the persistence of these sensory gains at the 12-month evaluation was seen across more than one clinical measure. While much more clinical research needs to be done to demonstrate efficacy, the types of changes we are observing are unexpected and very encouraging given that these are patients in the chronic stage of complete spinal injury."
Mr. McGlynn added, "While we need to be cautious when interpreting data from a small, uncontrolled trial, to our knowledge, this is the first time a patient with a complete spinal cord injury has been converted to a patient with an incomplete injury following transplantation of neural stem cells. We are encouraged that the cells appear to convey clinical benefit in such severely injured patients. We are therefore hopeful that we will see similar or greater benefit in AIS B and C patients, who already have partial sensation and motor function below the level of injury which could be further augmented by cell transplantation."
Patients in the study's first cohort all suffered a complete injury to the thoracic (chest-level) spinal cord. In a complete injury, there is no neurological function below the level of injury, and sensory function of all three patients was stable before transplantation of the HuCNS-SC cells. All three patients were transplanted four to nine months after injury with a dose of 20 million cells at the site of injury. The surgery, immunosuppression and the cell transplants have been well tolerated by all the patients. There were no abnormal clinical, electrophysiological or radiological responses to the cells, and all the patients have remained neurologically stable through the first 12 months following transplantation. Positive changes in sensitivity to touch, heat and electrical stimuli were observed in well-defined and consistent thoracic regions in two of the patients, while no changes were observed in the third patient. Importantly, quantitative tests of specific sensory function, as well as electrophysiological measures of impulse transmission across the site of injury, show an association with the clinical examination, providing further objective confirmation of the sensory gains.
About the Spinal Cord Injury Clinical Trial
The Phase I/II clinical trial of StemCells, Inc.'s HuCNS-SC(R) purified human adult neural stem cells is designed to assess both safety and preliminary efficacy. Twelve patients with thoracic (chest-level) neurological injuries at the T2-T11 level are planned for enrollment, and their injuries must have occurred within three to twelve months prior to transplantation of the cells. In addition to assessing safety, the trial will assess preliminary efficacy based on defined clinical endpoints, such as changes in sensation, motor function and bowel/bladder function. The Company has dosed the first three patients, all of whom have injuries classified as AIS A, in which there is no neurological function below the injury level. The injuries are classified according to the American Spinal Injury Association Impairment Scale (AIS). The second and third cohorts will be patients classified as AIS B and AIS C, those with less severe injury, in which there is some preservation of sensory or motor function.
All patients will receive HuCNS-SC cells through direct transplantation into the spinal cord and will be temporarily immunosuppressed. Patients will be evaluated regularly in the post-transplant period in order to monitor and assess the safety of the HuCNS-SC cells, the surgery and the immunosuppression, as well as to measure any recovery of neurological function below the injury site. The Company intends to follow the effects of this therapy long-term, and each of the patients will be invited to enroll into a separate four year observational study after completing the Phase I/II study.
The trial is being conducted at Balgrist University Hospital, University of Zurich, a world leading medical center for spinal cord injury and rehabilitation, and is open for enrollment to patients in Europe, Canada and the United States. Enrollment for the second cohort is currently underway, and the first AIS B patient was enrolled and dosed late last year. If you believe you may qualify and are interested in participating in the study, please contact the study nurse either by phone at +41 44 386 39 01 or by email at stemcells.pz@balgrist.ch.
Additional information about the Company's spinal cord injury program can be found on the StemCells, Inc. website at http://www.stemcellsinc.com/Therapeutic-Programs/Clinical-Trials.htm and at http://www.stemcellsinc.com/Therapeutic-Programs/Spinal-Cord-Injury.htm, including video interviews with Company executives and independent collaborators.
About Balgrist University Hospital
Balgrist University Hospital, University of Zurich is recognized worldwide as a highly specialized center of excellence providing examination, treatment and rehabilitation opportunities to patients with serious musculoskeletal conditions. The clinic owes its leading international reputation to its unique combination of specialized medical services. The hospital's carefully-balanced, interdisciplinary network brings together under one roof medical specialties including orthopedics, paraplegiology, radiology, anesthesiology, rheumatology, and physical medicine. More information about Balgrist University Hospital is available at www.balgrist.ch.
About StemCells, Inc.
StemCells, Inc. is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. The Company's lead therapeutic product candidate, HuCNS-SC(R) cells (purified human neural stem cells), is currently in development as a potential treatment for a broad range of central nervous system disorders. In a Phase I clinical trial in Pelizaeus-Merzbacher disease (PMD), a fatal myelination disorder in children, the Company has shown preliminary evidence of progressive and durable donor-derived myelination in all four patients transplanted with HuCNS-SC cells. The Company is also conducting a Phase I/II clinical trial in chronic spinal cord injury in Switzerland and has reported positive interim data for the first patient cohort. The Company has also initiated a Phase I/II clinical trial in dry age-related macular degeneration (AMD), and is pursuing preclinical studies in Alzheimer's disease. StemCells also markets stem cell research products, including media and reagents, under the SC Proven(R) brand. Further information about StemCells is available at http://www.stemcellsinc.com.
The StemCells, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=7014
Apart from statements of historical fact, the text of this press release constitutes forward-looking statements within the meaning of the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, and is subject to the safe harbors created therein. These statements include, but are not limited to, statements regarding whether the improvements in sensory function seen in the Company's Phase I/II clinical study of spinal cord injury will persist and whether they will prove to be clinically meaningful; continued authorization to conduct a clinical trial in Switzerland in chronic spinal cord injury; the prospect for screening and then enrolling patients into the AIS B and AIS C cohorts; the prospect for evaluating trial patients for changes in their sensation, motor function and bowel/bladder function; the potential of the Company's HuCNS-SC cells to treat spinal cord injury and other central nervous system disorders; and the future business operations of the Company, including its ability to conduct clinical trials as well as its other research and product development efforts. These forward-looking statements speak only as of the date of this news release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management's current views and are based on certain assumptions that may or may not ultimately prove valid. The Company's actual results may vary materially from those contemplated in such forward-looking statements due to risks and uncertainties to which the Company is subject, including the fact that additional trials will be required to demonstrate the safety and efficacy of the Company's HuCNS-SC cells for the treatment of any disease or disorder; uncertainty as to whether the FDA or other applicable regulatory agencies will permit the Company to continue clinical testing in spinal cord injury or in future clinical trials of proposed therapies for other diseases or conditions; uncertainties regarding the ability of preclinical research, including research in animal models, to accurately predict success or failure in clinical trials; uncertainties regarding the Company's ability to recruit the patients required to conduct its clinical trials or to obtain meaningful results; uncertainties regarding the Company's ability to obtain the increased capital resources needed to continue its current and planned research and development operations; uncertainty as to whether HuCNS-SC cells and any products that may be generated in the future in the Company's cell-based programs will prove safe and clinically effective and not cause tumors or other adverse side effects; uncertainties regarding the Company's ability to commercialize a therapeutic product and its ability to successfully compete with other products on the market; and other factors that are described under the heading "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2011, and in its subsequent reports on Form 10-Q and Form 8-K.
Contact:
Rodney Young
StemCells, Inc.
Chief Financial Officer
(510) 456-4128
Ian Stone
Russo Partners
(619) 308-6541