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CYTK Announces Opening of COSMIC-HF, a Phase II Clinical Trial of Oral Formulations of Omecamtiv Mecarbil in Patients with Heart Failure
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CYTK 1.04
South San Francisco, CA, February 12, 2013 - Cytokinetics, Incorporated (CYTK) announced today the opening to enrollment of a Phase II clinical trial of oral formulations of omecamtiv mecarbil. This trial, known as COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), is sponsored by Amgen in collaboration with Cytokinetics and is designed to evaluate the safety and efficacy of a novel cardiac muscle myosin activator, omecamtiv mecarbil, in patients with heart failure and left ventricular systolic dysfunction.
"We are pleased that this international Phase II clinical trial designed to evaluate several oral formulations of omecamtiv mecarbil is now open to enrollment," stated Andrew A. Wolff, MD, FACC, Cytokinetics` Senior Vice President of Clinical Research and Development and Chief Medical Officer. "The objective of this trial is to identify and characterize an oral modified-release formulation of omecamtiv mecarbil that may progress into the Phase III clinical program. The data from COSMIC-HF, in combination with the data from the ongoing ATOMIC-AHF clinical trial evaluating an intravenous formulation of omecamtiv mecarbil, will contribute to the design of a potential registration program for this drug candidate."
Amgen holds an exclusive, worldwide license (excluding Japan) to omecamtiv mecarbil and related compounds, subject to specified development and commercialization participation rights of Cytokinetics.
COSMIC-HF: Phase II Clinical Trial of Omecamtiv Mecarbil:
OSMIC-HF is a double-blind, randomized, placebo-controlled, multicenter, dose escalation study designed to select and evaluate an oral modified-release formulation of omecamtiv mecarbil in patients with heart failure and left ventricular systolic dysfunction. During the dose escalation phase, approximately 40 patients will be randomized 1:1:1:1 to placebo or one of three different oral formulations of omecamtiv mecarbil in each of two ascending dose pharmacokinetic (PK) cohorts to enable selection of one of these oral formulations for the planned expansion phase of the trial. The dose of omecamtiv mecarbil will be 25 mg twice daily in the first PK cohort and 50 mg twice daily in the second PK cohort. Following the dose escalation phase of the trial, there is a planned expansion phase of the trial in which approximately 300 patients will be randomized 1:1:1 to receive one oral formulation of omecamtiv mecarbil selected from the three studied in the prior ascending dose PK cohorts at one of two dose levels or placebo. The two dose levels of omecamtiv mecarbil to be studied in the expansion cohort will be based on the data from the ascending dose PK cohorts. The primary objectives of this study are to select an oral modified-release formulation and dose of omecamtiv mecarbil for chronic twice daily dosing in patients with heart failure and left ventricular systolic dysfunction and to characterize its safety, tolerability, and pharmacokinetics after 12 weeks of treatment. The secondary objectives are to assess the changes from baseline in systolic ejection time, stroke volume, left ventricular end-systolic diameter, left ventricular end-diastolic diameter, heart rate and N-terminal pro-brain natriuretic peptide (a biomarker associated with the severity of heart failure) after 12 weeks of treatment.
ATOMIC-AHF: Phase IIb Clinical Trial of Intravenous Omecamtiv Mecarbil
ATOMIC-AHF is an ongoing Phase IIb clinical trial designed to evaluate an intravenous formulation of omecamtiv mecarbil in approximately 600 patients enrolled in 3 sequential, ascending-dose cohorts. In each cohort, patients will be randomized 1:1 to omecamtiv mecarbil or placebo. The primary objective of this trial is to evaluate the effect of 48 hours of intravenous omecamtiv mecarbil compared to placebo on dyspnea (shortness of breath) in patients with left ventricular systolic dysfunction hospitalized for acute heart failure. The secondary objectives are to assess the safety and tolerability of 3 dose levels of intravenous omecamtiv mecarbil compared with placebo and to evaluate the effects of 48 hours of treatment with intravenous omecamtiv mecarbil on additional measures of dyspnea, patients` global assessments, change in N-terminal pro brain-type natriuretic peptide and short-term clinical outcomes in these patients. In addition, the trial is evaluating the relationship between omecamtiv mecarbil plasma concentrations and these parameters in patients with acute heart failure.
Development Status of Omecamtiv Mecarbil
In 2012, Cytokinetics and Amgen reviewed data from a prior Phase I randomized, open-label, 4-period cross-over clinical trial designed to assess the safety, tolerability and pharmacokinetics of multiple oral formulations of omecamtiv mecarbil in healthy volunteers. The formulations to be evaluated in COSMIC-HF were selected from among those oral formulations.
Prior to the conduct of the ATOMIC-AHF Phase IIb and COSMIC-HF Phase II clinical trials, omecamtiv mecarbil was the subject of a clinical trials program conducted by Cytokinetics comprised of five Phase I trials in healthy volunteers and two Phase IIa trials in patients with heart failure. Those trials were designed to evaluate the safety, tolerability, pharmacodynamic and pharmacokinetic profiles of both intravenous and oral formulations of omecamtiv mecarbil for the potential treatment of heart failure. Data from each of these trials were reported previously.
About Cytokinetics
Cytokinetics is a clinical-stage biopharmaceutical company focused on the discovery and development of novel small molecule therapeutics that modulate muscle function for the potential treatment of serious diseases and medical conditions. Cytokinetics` lead drug candidate from its cardiac muscle contractility program, omecamtiv mecarbil, is in Phase II clinical development for the potential treatment of heart failure. Amgen Inc. holds an exclusive license worldwide (excluding Japan) to develop and commercialize omecamtiv mecarbil and related compounds, subject to Cytokinetics` specified development and commercialization participation rights. Cytokinetics is independently developing tirasemtiv, a skeletal muscle activator, as a potential treatment for diseases and conditions associated with aging, muscle wasting or neuromuscular dysfunction. Tirasemtiv is currently the subject of a Phase II clinical trials program and has been granted orphan drug designation and fast track status by the U.S. Food and Drug Administration and orphan medicinal product designation by the European Medicines Agency for the potential treatment of amyotrophic lateral sclerosis, a debilitating disease of neuromuscular impairment in which treatment with tirasemtiv produced potentially clinically relevant pharmacodynamic effects in Phase II trials. All of these drug candidates have arisen from Cytokinetics` muscle biology focused research activities and are directed towards the cytoskeleton. The cytoskeleton is a complex biological infrastructure that plays a fundamental role within every human cell. Additional information about Cytokinetics can be obtained at www.cytokinetics.com.
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Cytokinetics disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Act`s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Cytokinetics` and Amgen`s research and development activities, including the progress, conduct, design and results of clinical trials, the significance and utility of clinical trial results, and the properties and potential benefits of omecamtiv mecarbil and Cytokinetics` other drug candidates and potential drug candidates. Such statements are based on management`s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics` drug candidates that could slow or prevent clinical development or product approval, including risks that current and past results of clinical trials or preclinical studies may not be indicative of future clinical trials results, patient enrollment for or conduct of clinical trials may be difficult or delayed, Cytokinetics` drug candidates may have adverse side effects or inadequate therapeutic efficacy, the U.S. Food and Drug Administration or foreign regulatory agencies may delay or limit Cytokinetics` or its partners` ability to conduct clinical trials, and Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; Amgen`s decisions with respect to the design, initiation, conduct, timing and continuation of development activities for omecamtiv mecarbil; Cytokinetics may incur unanticipated research and development and other costs or be unable to obtain additional financing necessary to conduct development of its products on acceptable terms, if at all; Cytokinetics may be unable to enter into future collaboration agreements for its drug candidates and programs on acceptable terms, if at all; standards of care may change, rendering Cytokinetics` drug candidates obsolete; competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics` drug candidates and potential drug candidates may target; and risks and uncertainties relating to the timing and receipt of payments from its partners, including milestones and royalties on future potential product sales under Cytokinetics` collaboration agreements with such partners. For further information regarding these and other risks related to Cytokinetics` business, investors should consult Cytokinetics` filings with the Securities and Exchange Commission.
Contact:
Joanna (Jodi) L. Goldstein
Manager, Corporate Communications & Marketing
(650) 624-3000
GTXI Announces Webcast for Capesaris®(GTx-758) Analyst Day
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GTXI 4.83
MEMPHIS, Tenn.--(BUSINESS WIRE)--
GTx, Inc. (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. The presentations will be conducted by an expert faculty panel to include: Phillip Kantoff, MD, Dana-Farber Cancer Institute/Brigham and Women’s Hospital; Thomas Flaig, MD, University of Colorado School of Medicine; and Evan Yu, MD, Fred Hutchinson Cancer Research Center.
Register for the live webcast at (http://www.media-server.com/m/p/tseh66fk).
Contact:
GTx, Inc.
Marc Hanover, 901-523-9700
President
VNDA Reports Fourth Quarter 2012 and Full Year 2012 Results
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VNDA 3.92
WASHINGTON, Feb. 12, 2013 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (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.
Key Highlights:
Vanda reported positive SET and RESET Phase III efficacy studies for tasimelteon in the treatment of patients with Non-24-Hour Disorder (Non-24). Study results demonstrate tasimelteon is a unique circadian regulator that resets the master body clock and improves clinical symptoms in patients with Non-24.
The tasimelteon Non-24 program continues towards the goal of a projected mid-2013 New Drug Application (NDA) filing with the U.S. Food and Drug Administration (FDA).
All tasimelteon activities have been discontinued related to the Major Depressive Disorder (MDD) indication. In January 2013, Vanda announced that the MAGELLAN Phase IIb/III clinical study did not meet its primary endpoint.
Vanda has formally requested a re-examination of the negative opinion issued by the European Medicines Agency (EMA) recommending against approval of Fanaptum™ (oral iloperidone tablets) in the European Union.
Vanda recorded full year 2012 revenue of $32.7 million including Fanapt® royalties of $5.9 million. Fanapt® prescriptions, as reported by IMS, were approximately 38,200 for the fourth quarter of 2012. This represents a 1% decrease versus third quarter 2012 prescriptions and a 13% increase over fourth quarter 2011 prescriptions.
FULL YEAR 2012 REPORTED RESULTS
Total revenues for the full year 2012 were $32.7 million, compared to $31.3 million for 2011. Full year 2012 revenues included $5.9 million in Fanapt® royalties received from Novartis, as compared to $4.5 million for the prior year. Both 2012 and 2011 revenues include $26.8 million recognized from the $200.0 million upfront payment previously received from Novartis for Fanapt® U.S. and Canadian rights.
Total operating expenses for 2012 were $61.0 million, compared to $42.0 million for 2011. The primary driver of the higher expenses in 2012 was the ongoing support of the tasimelteon Non-24 and MDD clinical studies.
Vanda recorded a net loss of $27.7 million for 2012, compared to net loss of $9.8 million for 2011. Diluted net loss per share for 2012 was $0.98, compared to a diluted net loss per share of $0.35 for 2011.
Vanda's cash, cash equivalents and marketable securities as of December 31, 2012 totaled $120.4 million.
FOURTH QUARTER 2012 REPORTED RESULTS
Total revenues for the fourth quarter of 2012 were $7.9 million, compared to $8.4 million for 2011. Fourth quarter 2012 revenues included $1.2 million in Fanapt® royalties received from Novartis as compared to royalties of $1.6 million for the fourth quarter of 2011.
Total operating expenses for the fourth quarter of 2012 and 2011 were each $14.3 million.
Vanda recorded a net loss of $6.4 million for the fourth quarter of 2012, compared to a net loss of $5.5 million for the fourth quarter of 2011. Diluted net loss per share for the fourth quarter of 2012 was $0.23, compared to a diluted net loss of $0.20 per share for the fourth quarter of 2011.
http://finance.yahoo.com/news/vanda-pharmaceuticals-reports-fourth-quarter-115500643.html
IMGN Attains Patient Enrollment Milestone in IMGN901 NORTH Trial
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IMGN 14.69
WALTHAM, Mass.--(BUSINESS WIRE)--
ImmunoGen, Inc. (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. The NORTH trial is assessing the Company’s IMGN901 product candidate for first-line treatment of extensive disease small-cell lung cancer (SCLC). Attaining this milestone enables the findings from the planned interim analysis of PFS at 6 months to be available in 2H2013.
The NORTH trial is designed to assess whether IMGN901 provides a clinically meaningful benefit when used in conjunction with a standard-of-care for this cancer, etoposide plus carboplatin (E/C). Patients with newly diagnosed extensive disease SCLC enrolled in the trial are randomized, two-to-one, to treatment either with IMGN901 plus E/C or with E/C alone.
While the NORTH trial is designed to include a total of 120 patients, its two-stage design specifies that an analysis of PFS at six months is to be performed with the first 39 evaluable patients randomized to the IMGN901 plus E/C treatment arm. Patient enrollment of this cohort of patients – and the corresponding 20 patients in the E/C alone arm – has now been completed. These patients will now be followed for the interim analysis while patient enrollment continues.
“Achieving timely enrollment of patients with small-cell lung cancer is known to be challenging, and we believe our attainment of this milestone on schedule speaks to both the clinical need for new therapies for SCLC and our increasing strength as a development company,” commented James O’Leary, MD, Vice President and Chief Medical Officer. “When available, we intend to use the findings from the interim analysis to make decisions related to the development of IMGN901. We also plan to submit them for presentation at a medical conference.”
ImmunoGen’s NORTH Trial
The 120-patient NORTH trial is designed to evaluate the efficacy and safety of IMGN901 for first-line treatment of extensive disease SCLC. All patients enrolled are provided with up to six cycles of E/C, standard-of-care for this cancer. Two-thirds of the patients enrolled are randomized to also receive IMGN901. These patients can elect to remain on IMGN901, as monotherapy, after completion of the E/C cycles if benefiting from treatment.
The primary endpoint of the NORTH trial is progression-free survival (PFS). Secondary endpoints include PFS at 6 months, overall survival at 12 months, time to progression, overall survival, and overall response rate.
About IMGN901
IMGN901 was developed by ImmunoGen to target and kill CD56-positive cancer cells. CD56 is expressed on virtually all cases of SCLC. It is also expressed on a variety of other cancers including Merkel cell carcinoma and many cases of multiple myeloma.
IMGN901 employs the Company’s Targeted Antibody Payload (TAP) technology, which uses a CD56-binding antibody to target one of ImmunoGen’s highly potent cell-killing agents to CD56-positive cancer cells.
About SCLC
It is estimated that approximately 29,400 new cases of SCLC will be diagnosed in the United States this year.1 Approximately two-thirds of patients have extensive disease at the time of diagnosis, as SCLC tends to spread broadly through the body quite early in its course.2 As a result, SCLC is usually treated with chemotherapy rather than with surgery.3 Median PFS for extensive disease SCLC is approximately 5.5 months, while median overall survival averages 9-11 months.3,4
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company’s TAP technology uses a tumor-targeting monoclonal antibody to deliver one of ImmunoGen's highly potent cancer-killing agents specifically to tumor cells. Ten TAP compounds are now in clinical testing, of which three are wholly owned by the Company. Marketing applications for trastuzumab emtansine (T-DM1), the most advanced compound using ImmunoGen's TAP technology, are under review in the US, Europe and Japan. Roche is developing this compound globally under an agreement between ImmunoGen and Genentech, a member of the Roche Group. More information about ImmunoGen can be found at www.immunogen.com.
1 American Cancer Society, Cancer Facts & Figures 2012.
2 American Cancer Society, Lung Cancer (Small Cell) 2012.
3National Comprehensive Cancer Network (NCCN) Guidelines.
4Foster, NR, Qi, Y, Krook, JE, et al. (2009). J Clin Oncol, 27(15s).
This press release includes forward-looking statements. For these statements, ImmunoGen claims the protection of the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act of 1995. It should be noted that there are risks and uncertainties related to the development of novel anticancer products, including IMGN901, including risks related to preclinical and clinical studies, their timings and results. A review of these risks can be found in ImmunoGen’s Annual Report on Form 10-K for the fiscal year ended June 30, 2012 and other reports filed with the Securities and Exchange Commission.
Contact:
For Investors:
ImmunoGen, Inc.
Carol Hausner, 781-895-0600
Executive Director, Investor Relations and Corporate Communications
info@immunogen.com
or
For Media:
The Yates Network
Barbara Yates, 781-258-6153
ZIOP -Phase 3 Trial of ZIOPHARM'S Palifosfamide in First-Line Metastatic Soft Tissue Sarcoma Reaches Target Number of Progression-Free Survival Events
Results Will be Announced Last Week of March
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Symbol Price Change
ZIOP 3.99
NEW YORK, Feb. 12, 2013 (GLOBE NEWSWIRE) -- ZIOPHARM Oncology, Inc. (ZIOP) announced today that the Phase 3 (PICASSO 3) trial of palifosfamide (ZIO-201) in first-line metastatic soft tissue sarcoma has 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."
About ZIOPHARM Oncology, Inc.:
ZIOPHARM Oncology is a biopharmaceutical company focused on the development and commercialization of new cancer therapies. The Company's clinical programs include:
Palifosfamide (ZIO-201) is a potent bi-functional DNA alkylating agent that has activity in multiple tumors by evading typical resistance pathways. Palifosfamide is in the same class as bendamustine, cyclophosphamide, and ifosfamide. Intravenous palifosfamide is currently being studied in a randomized, double-blinded, placebo-controlled Phase 3 trial (PICASSO 3) for the treatment of first-line metastatic soft tissue sarcoma and is also in a pivotal Phase 3 trial (MATISSE) for first-line metastatic small cell lung cancer. Additionally, the Company is developing an oral capsule form of palifosfamide.
Ad-RTS IL-12 is currently being tested in a Phase 2 study. Ad-RTS IL-12 uses synthetic biology to enable controlled, local delivery of therapeutic interleukin-12 (IL-12), a protein important for an immune response to cancer. ZIOPHARM's DNA synthetic biology platform is being developed in partnership with Intrexon Corporation and employs an inducible gene-delivery system that enables controlled, local delivery of genes that produce therapeutic proteins to treat cancer. This is achieved by placing IL-12 under the control of a proprietary biological "switch" (the RheoSwitch Therapeutic System(R), RTS(R)) to turn on/off the therapeutic protein expression at the tumor site.
Indibulin (ZIO-301) is a novel, tubulin binding agent that is expected to have several potential benefits, including oral dosing, application in multi-drug resistant tumors, no neuropathy and a tolerable toxicity profile. It is currently being studied in a Phase 1/2 trial in metastatic breast cancer.
Darinaparsin (ZIO-101) is a novel mitochondrial-and hedgehog-targeted agent (organic arsenic) currently in ongoing studies with Solasia Pharma K.K.
ZIOPHARM's operations are located in Boston, MA, and New York City. Further information about ZIOPHARM may be found at www.ziopharm.com.
Forward-Looking Safe Harbor Statement:
This press release contains certain forward-looking information about ZIOPHARM Oncology that is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. Words such as "expect(s)," "feel(s)," "believe(s)," "will," "may," "anticipate(s)" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding our ability to successfully develop and commercialize our therapeutic products; our ability to expand our long-term business opportunities; financial projections and estimates and their underlying assumptions; and future performance. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include, but are not limited to: whether Palifosfamide, Ad-RTS IL-12, Darinaparsin, Indibulin, or any of our other therapeutic products will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether Palifosfamide, Ad-RTS IL-12, Darinaparsin, Indibulin, and our other therapeutic products will be successfully marketed if approved; whether any of our other DNA-based biotherapeutics discovery and development efforts will be successful; our ability to achieve the results contemplated by our collaboration agreements; the strength and enforceability of our intellectual property rights; competition from pharmaceutical and biotechnology companies; the development of and our ability to take advantage of the market for DNA-based biotherapeutics; our ability to raise additional capital to fund our operations on terms acceptable to us; general economic conditions; and the other risk factors contained in our periodic and interim SEC reports filed from time to time with the Securities and Exchange Commission, including but not limited to our Annual Report on Form 10-K for the fiscal year ended December 31, 2011, and our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2012. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.
Contact:
For ZIOPHARM
Nicole Jones
ZIOPHARM Oncology, Inc.
617-778-2266
njones@ziopharm.com
Media Contacts:
David Schull or Lena Evans
Russo Partners, LLC
858-717-2310
212-845-4262
david.schull@russopartnersllc.com
lena.evans@russopartnersllc.com
CYCC Announces Grants of New U.S. & European Patents Covering Sapacitabine Used in Combination With HDAC Inhibitors
Granted Patents Provide Exclusivity for Potential Uses of Sapacitabine in Hematological Malignancies and Solid Tumors
Symbol Price Change
CYCC 5.39
BERKELEY HEIGHTS, N.J., Feb. 12, 2013 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (CYCC) (CYCCP) (Cyclacel or the Company), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, today announced the issuance of U.S. Patent No. US 8,349,792 ('792) and European Patent No 2,101,790 ('790). Both patents include claims to combination treatment of sapacitabine, the Company's lead product candidate, with HDAC (histone deacetylase) inhibitors. The patents provide exclusivity until June 2029 and December 2027 respectively.
"The grants of the '792 and '790 patents are important enhancements of sapacitabine's intellectual property estate. They supplement sapacitabine's existing composition of matter, dosing regimen and combination treatment patent protection and support US and EU market exclusivity toward the end of the next decade," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "We are pursuing a broad intellectual property strategy providing us with a strong foundation to achieve our clinical and commercial objectives for sapacitabine and our other assets. As we continue to enroll SEAMLESS, our pivotal Phase 3 trial of sapacitabine as front-line treatment in elderly patients with acute myeloid leukemia (AML), we look forward to providing additional updates for sapacitabine this year, including Phase 2 data in myelodysplastic syndromes (MDS), AML preceded by MDS, and solid tumors."
The two patents include claims to combinations of sapacitabine and HDAC inhibitors, pharmaceutical compositions comprising sapacitabine and HDAC inhibitors, and methods of treatment using such compositions of proliferative disorders including leukemias, lymphomas, and lung cancer. HDAC inhibitors specifically claimed include belinostat (PXD101), dacinostat (LAQ824), entinostat (MS-275), mocetinostat (MGCD0103), pracinostat (SB939), romidepsin (depsipeptide), sodium butyrate, sodium valproate, tacedinaline (CI-994, PD-123654, GOE-5549, acetyldinaline), trichostatin A, vorinostat (SAHA or suberoylanilide hydramic acid), and valproic acid. Cyclacel published preclinical model data in 2010 demonstrating that sapacitabine works synergistically with histone deacetylase (HDAC) inhibitors to induce significant reductions in tumor cell growth in vitro and in vivo.
The claims and specifications of the '792 and '790 patents are unrelated to the claims and specifications of the four Cyclacel-owned patents that are the subject of Cyclacel's intellectual property litigation with Celgene Corporation (Celgene) regarding Celgene's drug romidepsin (depsipeptide, Istodax(R)).
About sapacitabine
Sapacitabine (CYC682), an orally-available nucleoside analogue, is currently being studied in an ongoing, Phase 3, registration-directed trial in elderly patients aged 70 years or older with newly diagnosed AML who are not candidates for or have refused induction chemotherapy. Sapacitabine is also the subject of Phase 2 trials in patients with hematological malignancies, including AML, myelodysplastic syndromes (MDS), cutaneous T-cell lymphoma (CTCL), chronic lymphocytic leukemia and small lymphocytic lymphoma, and non-small cell lung cancer (NSCLC), and a Phase 1 trial in combination with seliciclib in patients with advanced solid tumors. Sapacitabine acts through a novel DNA single-strand breaking mechanism, leading to production of DNA double strand breaks (DSBs) and/or checkpoint activation. Unrepaired DSBs cause cell death. Repair of sapacitabine-induced DSBs is dependent on the homologous recombination DNA repair (HRR) pathway. Both sapacitabine and CNDAC, its major metabolite, have demonstrated potent anti-tumor activity in preclinical studies.
Over 500 patients have received sapacitabine in Phase 2 studies in AML, MDS, CTCL and NSCLC and Phase 1 studies in hematological malignancies and solid tumors. Data, discussed at two separate sessions at The Eighth Annual Hematologic Malignancies 2012 Conference, from an ongoing, multicenter, phase 2 randomized trial of single-agent oral sapacitabine capsules in older patients with intermediate-2 or high-risk myelodysplastic syndromes (MDS) after treatment failure of front-line hypomethylating agents, such as azacitidine (Vidaza(R)) and/or decitabine (Dacogen(R)), showed sapacitabine nearly doubles expected survival of elderly patients with MDS after front-line therapy failure. Results from a randomized Phase 2, single-agent study of sapacitabine, including promising 1-year survival in elderly patients with AML aged 70 years or older, were published in The Lancet Oncology in November 2012. At the 2012 ASH Annual Meeting, Cyclacel reported data from the pilot study and lead-in phase of SEAMLESS including promising response rate, overall survival and low 30-day and 60-day mortality in elderly patients with AML aged 70 years or older receiving sapacitabine alternating with decitabine. The FDA and the European Medicines Agency have designated sapacitabine as an orphan drug for the treatment of both AML and MDS. Sapacitabine is part of Cyclacel's pipeline of small molecule drugs designed to target and stop uncontrolled cell division.
About Cyclacel Pharmaceuticals, Inc.
Cyclacel is a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious diseases. The Company's most advanced oral product candidate, sapacitabine, is the subject of SEAMLESS, a Phase 3 trial being conducted under an SPA with the FDA as front-line treatment of acute myeloid leukemia (AML) in the elderly and Phase 2 studies for AML, myelodysplastic syndromes (MDS), chronic lymphocytic leukemia (CLL) and solid tumors including breast, lung, ovarian and pancreatic cancer. Cyclacel's pipeline includes seliciclib, a CDK inhibitor, in Phase 2 for lung and nasopharyngeal cancer and in Phase 1 in combination with sapacitabine; and CYC065, a second generation CDK inhibitor, in IND-directed development. Cyclacel's strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a development pipeline of novel drug candidates. Please visit www.cyclacel.com for additional information.
Forward-looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and intended utilization of Cyclacel's product candidates, the conduct and results of future clinical trials, plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, trials may have difficulty enrolling, Cyclacel may not obtain approval to market its product candidates, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to our most recent Annual Report on Form 10-K and other periodic and other filings we file with the Securities and Exchange Commission and are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
(C) Copyright 2013 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel(R) are trademarks of Cyclacel Pharmaceuticals, Inc. Istodax(R) and Vidaza(R) are registered trademarks of Celgene Corporation. Dacogen(R) is a registered trademark used by Eisai Inc. under license from Astex Pharmaceuticals, Inc.
Contact:
Investors/Media:
Corey Sohmer
(908) 517-7330
csohmer@cyclacel.com
BOTA Reports Second Quarter Financial Results and Corporate Update
Symbol Price Change
BOTA 3.90
ROCKVILLE, MD--(Marketwire - Feb 12, 2013) - Biota Pharmaceuticals, Inc. ( NASDAQ : BOTA )
LANI Influenza Program Advancing Toward Phase 2 Clinical Development
Merger between Nabi Biopharmaceuticals and Biota Holdings Limited Successfully Completed
Biota Pharmaceuticals, Inc. ( NASDAQ : BOTA ) today announced its financial results for the three month period ended December 31, 2012 and recent corporate developments. The Company's fiscal year end is June 30.
"We are pleased with the progress of the LANI program such that we anticipate initiating a large, global Phase 2 clinical trial in patients with influenza in mid-2013," stated Russell H. Plumb, President and CEO of Biota Pharmaceuticals, Inc. "With the merger behind us and our balance sheet strengthened with the related net cash proceeds, we are now focused on integrating operations and completing an in-depth strategic, operational and financial review of our development programs, which we expect to complete by the end of this quarter."
Recent Corporate Developments
Merger between Nabi Biopharmaceuticals and Biota Holdings Limited - On November 8, 2012, the Company announced the completion of the merger between Nabi and Biota Holdings Limited, resulting in the formation of Biota Pharmaceuticals, Inc. Former Biota Holdings Limited shareholders retained approximately 83% of the Company's shares of common stock, while former Nabi shareholders retained approximately 17% as consideration for Nabi's net assets, which consisted primarily of $27 million in net cash on the date of the merger. The merger has been accounted for as a reverse merger, such that Biota Holdings Limited is considered the accounting acquirer for financial reporting purposes even though Nabi was the legal acquirer.
Reverse Stock Split - Concurrent with the completion of the merger, a reverse stock split of Nabi common stock occurred, resulting in each six shares of Nabi common stock issued and outstanding immediately prior to the reverse split being automatically combined into one share of Nabi common stock. As a result of the reverse split, the per share exercise price of, and the number of shares of common stock underlying all stock options outstanding immediately prior to the reverse split were automatically proportionally adjusted based on the 1:6 ratio in accordance with the terms of such options.
Laninamivir Octanoate (LANI) - Laninamivir octanoate is marketed in Japan by Daiichi Sankyo as Inavir® for the treatment of influenza A and B in adults and children. In November 2012, Daiichi Sankyo submitted an application for a label change in Japan to manufacture and market the influenza antiviral product Inavir® for the prevention of influenza A and B.
Under the contract the Company has with the U.S. Office of Biomedical Advanced Research and Development Authority ("BARDA"), in January 2013 the Company initiated a Phase 1 clinical trial designed to assess the pharmacokinetics and metabolite profile of laninamivir octanoate following an inhaled dose administered via TwinCaps®. This study is a single center, single dose, open-label study in six healthy male subjects. The Company anticipates that top-line results from this study will be available in mid-2013. Further, the Company anticipates initiating a 636-patient, randomized, placebo-controlled Phase 2 clinical trial of laninamivir octanoate in mid-2013. The primary objective of the study is to evaluate the safety and efficacy of two doses of inhaled laninamivir octanoate (40 and 80 mg) delivered via TwinCaps® in adults with symptomatic presumptive influenza A or B infection. The primary endpoint for this study is time to alleviation of influenza symptoms and fever for = 24 hours.
Executive Management Changes - In connection with the merger, on November 14, 2012, the Company announced the appointment of Russell H. Plumb as its President and Chief Executive Officer, as well as a director, and Joseph M. Patti, M.S.P.H., Ph.D. as its Executive Vice President, Corporate Development & Strategy. Peter Cook, who resigned as the Chief Executive Officer of Biota Holdings Limited upon the completion of the merger, continues to serve as a director.
Mr. Plumb previously served as President, Chief Executive Officer and Chief Financial Officer of Inhibitex, Inc., a publicly-traded clinical-stage drug development company, from December 2006 through February 2012, when it was acquired. From 2000 to December 2006, Mr. Plumb was the Chief Financial Officer of Inhibitex.
Dr. Patti was a co-founder of Inhibitex, and served as its Chief Scientific Officer and Senior Vice President of Research and Development from 2007 through February 2012. Prior to that, he served as the Vice President, Research and Development and Chief Scientific Officer from 2005 to 2007 and Vice President of Preclinical Development from 1998 to 2005.
Financial Results for the Three Month Period Ended December 31, 2012
As of December 31, 2012, the Company held $74.1 million in cash and cash equivalents.
The Company reported net income in the three month period ended December 31, 2012 of $4.8 million, as compared to a net loss of $7.0 million in the second quarter of 2011. The $11.8 million change from net loss in 2011 to net income in 2012 was primarily the result of an $8.2 million increase in revenue, the recording of a $7.8 million gain related to the merger, and the receipt of a $4.4 million research and development credit, offset in part by a $7.7 million increase in total operating expenses, a $0.4 million decrease in interest income and a $0.5 million decrease in income tax benefits. Basic and diluted net income per share were $0.17 for the three month period ended December 31, 2012, as compared to a net basic and diluted loss per share of $0.31 in the same period of 2011.
Revenue increased to $10.4 million for the three months ended December 31, 2012 from $2.1 million in the same period of 2011, primarily as a result of increased service revenue in 2012 due principally to the advancement of the laninamivir octanoate program under the BARDA contract and higher royalty revenue.
Cost of revenue increased to $7.1 million in the three months ended December 31, 2012 from $2.9 million in the same three month period in 2011 due principally to the advancement of the laninamivir octanoate program under the BARDA contract.
Research and development expense decreased to $4.0 million in the second quarter of 2012 from $5.7 million in the second quarter of 2011, due largely to the completion of the vapendavir Phase 2 clinical trial during the quarter ended June 30, 2012, as well as lower preclinical costs associated with our antibacterial and hepatitis C virus programs and lower personnel-related and other indirect costs in general.
General and administrative expense increase to $7.1 million in the second quarter of 2012 as compared to $1.9 million in the second quarter of 2011 primarily due to merger-related costs of $3.3 million in 2012, an increase in salaries, benefits, stock-based compensation and recruiting costs related to the addition of executive and administrative staff in the U.S., as well as generally higher insurance, rent, and maintenance costs.
About Influenza and Laninamivir Octanoate
Influenza is a contagious and potentially fatal disease caused by a virus which infects the respiratory tract. Influenza viruses replicate in the cells lining the airways of the lungs and are generally spread directly to and from the respiratory tract by coughing and sneezing. Influenza can seriously affect anyone, but the people at highest risk of severe disease include young children, adults older than 65, and people of any age with underlying medical conditions, such as chronic heart, lung, kidney, liver, blood or metabolic diseases (for example, diabetes), or weakened immune systems.
Influenza spreads rapidly around the world in seasonal epidemics affecting between 5-15% of the population each year. According to the Centers for Disease Control and Prevention, in the U.S. alone, more than 200,000 people are hospitalized on average every year with influenza complications, and about 36,000 people die due to the disease. The World Health Organization estimates that annual epidemics around the world cause between three and five million cases of severe influenza, resulting in between 250,000 and 500,000 deaths every year.
The Company has developed first and second generation neuraminidase inhibitors, the first of which is zanamivir, which is marketed as Relenza® by GlaxoSmithKline. The Company's second generation neuraminidase inhibitors are referred to as long-acting neuraminidase inhibitors (LANIs) and are being evaluated as a once-weekly or once-only inhaled dose as compared to five day, twice-daily dosing needed with first generation neuraminidase inhibitors. The Company and Daiichi Sankyo co-own the rights for the development and commercialization of LANIs. The lead LANI, known as laninamivir octanoate, has completed clinical development in Japan and is marketed by Daiichi Sankyo as Inavir®.
In 2011, the Company announced it had been awarded a contract from BARDA for up to $231 million designed to support the clinical development and U.S. based manufacturing for laninamivir octanoate for the treatment of influenza A and B infections.
About Human Rhinovirus and Vapendavir
Human rhinoviruses (HRV) are a member of a large family of small viruses known as picornaviruses which are responsible for human diseases ranging from mild respiratory tract infections (the common cold) to paralytic poliomyelitis. HRV are the most commonly isolated viruses from people with mild upper respiratory tract illness. HRV can be a much more serious problem for some segments of the population such as infants and the frail elderly. HRV is a major cause of hospitalization for patients with underlying respiratory conditions, such as asthma, chronic obstructive pulmonary disease (COPD) and cystic fibrosis, where HRV can aggravate their existing disease. Estimates suggest that HRV is linked to about 70% of all asthma exacerbations and more than 50% of the hospitalized cases. Studies also suggest that more than 35% of acute COPD patients requiring hospitalization are associated with respiratory viruses, including rhinovirus.
The Company is developing vapendavir, a potent oral broad spectrum inhibitor of HRVs for the treatment of human rhinovirus infections and the reduction of exacerbations in patients with moderate to severe asthma or COPD. Vapendavir binds to the capsid of the HRVs and effectively stops the infection by interfering with the early steps in the infectious cycle. In March 2012, the Company announced that it had successfully completed a Phase 2b study in asthmatics with naturally acquired HRV infection.
About Biota
Biota Pharmaceuticals, Inc. is a biopharmaceutical company focused on the discovery and development of innovative anti-infective products to prevent and treat a number of serious and potentially life-threatening viral and bacterial infectious diseases. The Company currently has two Phase 2 clinical-stage development programs, laninamivir octanoate and vapendavir, and also has preclinical programs focused on developing treatments for respiratory syncytial virus (RSV) infections, hepatitis C virus (HCV), gram-positive and gram-negative bacterial infections. For additional information about the Company, please visit www.biotapharma.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve known and unknown risks and uncertainties. All statements, other than historical facts, including statements regarding: the timing of commencement and/or completion of the Company's clinical trials; the planned design, size and timing of when the Company anticipates initiating a 636-patient, placebo-controlled Phase 2 clinical trial of laninamivir octanoate; and the anticipated time to complete management's ongoing strategic, operational and financial review, are forward looking statements. Various important factors could cause actual results, performance, events or achievements to materially differ from those expressed or implied by the forward-looking statements, including: BARDA not terminating or significantly amending the Company's existing contract to develop laninamivir octanoate for the U.S.; the Company, BARDA, the FDA, a data safety monitoring board, or an institutional review board, delaying, limiting, suspending or terminating the clinical development of laninamivir octanoate at any time for a lack of safety, tolerability, anti-viral activity, commercial viability, regulatory or manufacturing issues, or any other reason whatsoever; the Company's ability to comply with extensive government regulations in various countries and regions in which it expects to conduct clinical trials; the Company's ability to secure, manage and retain qualified third-party clinical research, preclinical research, data management and contract manufacturing organizations who it relies on to assist in the design, development and implementation of the clinical development of its product candidates, including laninamivir octanoate; and other cautionary statements contained elsewhere in this press release and in the Company's Quarterly Report on Form 10-Q for the quarter ended December 31, 2012, as filed with the Securities and Exchange Commission, or SEC, on February 11, 2013.
There may be events in the future that the Company is unable to predict, or over which it has no control, and the Company's business, financial condition, results of operations and prospects may change in the future. The Company may not update these forward-looking statements more frequently than quarterly unless it has an obligation under U.S. Federal securities laws to do so.
Biota is a registered trademark of Biota Holdings Limited. Relenza™ is a trademark of GlaxoSmithKline plc, Inavir® is a registered trademark of Daiichi Sankyo Company, Ltd, and TwinCaps® is a registered trademark of Hovione FarmaCiencia SA.
http://finance.yahoo.com/news/biota-pharmaceuticals-reports-second-quarter-120000868.html
SPPI Spectrum Pharmaceuticals Announces Fourth Quarter and Fiscal Year 2012 Financial Results Teleconference and Webcast
SPPI 12.20
HENDERSON, Nev.--(BUSINESS WIRE)--
Spectrum Pharmaceuticals (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.
Conference Call
Thursday, February 21, 2013 @ 1:30 p.m. Eastern/10:30 a.m. Pacific
Domestic: (877) 837-3910, Conference ID# 94256900
International: (973) 796-5077, Conference ID# 94256900
For interested individuals unable to join the call, a replay will be available from February 21, 2013 @ 4:30 p.m. ET/1:30 p.m. PT through March 07, 2013 until 11:59 p.m. ET/8:59 p.m. PT.
Domestic Replay Dial-In #: (855) 859-2056, Conference ID# 94256900
International Replay Dial-In #: (404) 537-3406, Conference ID# 94256900
This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals' website: www.sppirx.com on February 21, 2013 @ 1:30 p.m. ET/10:30 a.m. PT.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in oncology and hematology. Spectrum and its affiliates market three oncology drugs - FUSILEV® (levoleucovorin) for Injection in the U.S.; FOLOTYN® (pralatrexate injection), also marketed in the U.S.; and ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use, for which the Company has worldwide marketing rights. Spectrum's strong track record in in-licensing and acquiring differentiated drugs, and expertise in clinical development have generated a robust, diversified, and growing pipeline of product candidates in advanced-stage Phase 2 and Phase 3 studies. More information on Spectrum is available at www.sppirx.com.
Forward-looking statement — This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management's current beliefs and expectations. These statements include, but are not limited to, statements that relate to our business and its future, including certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and employees around the world to assist us in the execution of our strategy, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates may not prove safe or effective, the possibility that our existing and new applications to the FDA and other regulatory agencies may not receive approval in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of sustained revenue history, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC.®, FUSILEV®, FOLOTYN®, and ZEVALIN® are registered trademarks of Spectrum Pharmaceuticals, Inc and its affiliates. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
© 2013 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Contact:
Spectrum Pharmaceuticals
Shiv Kapoor, 702-835-6300
Vice President, Strategic Planning & Investor Relations
InvestorRelations@sppirx.com
RDY -Dr. Reddy's declares offer for Octoplus unconditional (RDY) 35.98 : Dr. Reddy's and OctoPlus jointly announce that the Offeror declares the Offer unconditional.
Highlights
The Offeror declares the Offer unconditional (doet het bod gestand)
70.7% of the Shares have been tendered under the Offer, which together with Shares acquired by the Offeror during the Offer Period represent in total 92.7% of the Shares
Settlement of the Offer will take place on 15 February 2013
Shareholders can still tender their Shares during a Post Closing Acceptance Period (na-aanmeldingstermijn), starting on 13 February 2013 and ending on 26 February 2013
The Offeror intends to acquire all Shares and to terminate the Company's listing on NYSE Euronext Amsterdam as soon as possible
TROV -TrovaGene announces commercial launch timelines for HPV carrier and oncogene mutation tests (TROV) 6.75 : Co announes that the development of its proprietary, urine-based HPV carrier screening test is progressing well and the co expects to achieve analytical and clinical validation of the test in its CLIA laboratory in March 2013. When validation is completed, the test will be available to clinicians and their patients. In addition to the ongoing HPV validation studies, one clinical trial has been completed in India and two additional trials are underway in Brazil and India.
The Company has extended its planned offering of urine-based oncogene mutation tests for 2013 to include a test for the detection of a specific p53 mutation and a specific double mutation in the hepatitis B virus. Availability of the HCC test is anticipated in the fourth quarter of 2013. Trovagene's KRAS oncogene mutation test is expected to be introduced in the second quarter 2013. In support of the co's BRAF oncogene mutation test, a clinical trial with MD Anderson focused on mutations in patients with advanced or metastatic cancers is ongoing. It is anticipated that sufficient clinical specimens will be obtained to support a third quarter offering of this test. Additional clinical studies, including a trial to evaluate the detection of PIK3CA oncogene mutations, are in preparation.
AMRN -Amarin announces notification of patent allowance for U.S. application 13/614,129 related to Vascepa and FDA approved MARINE indication (AMRN) 8.49 : Co announced today that the United States Patent and Trademark Office has published notification of Notice of Allowance for U.S. Patent Application Serial Number 13/614,129. This application includes claims intended to protect the Vascepa indication approved by the FDA based on Amarin's MARINE clinical trial results.
BIO updates Monday February 11, 2013
Life Technologies Corporation (NASDAQ: LIFE) announced it has received U.S. FDA 510(k) clearance for its 3500 Dx Genetic Analyzers and SeCore® HLA typing kits. The development represents additional execution against the company's strategy to become a leader in the diagnostics market by offering both novel clinical assays and best- in-class molecular testing products.
"This successful application for our Sanger sequencer with HLA typing kits is further demonstration of Life Technologies' track record in obtaining FDA regulatory clearance for genetic analysis in the clinical market," said Greg Lucier, chairman and chief executive officer of Life Technologies. "We will continue to aggressively pursue a regulatory pathway for our leading technologies in the clinical space, including next-generation sequencing."
The company's 7500 Fast Dx Real-time PCR system was cleared for diagnostic use with the Center for Disease Control's H1N1 assay in 2008. Life Technologies has also announced plans to submit its next-generation sequencing instrument, the Ion Torrent Personal Genome Machine (PGM™) for 510(k) clearance.
The Applied Biosystems™ 3500 Dx/3500xL Dx CS2 Genetic Analyzers, Invitrogen SeCore® HLA Sequencing Kits, and uTYPE® Dx HLA Sequence Analysis Software constitute the first 510(k)-cleared, sequence-based system for HLA typing in the United States. Tissue typing is an essential component of determining compatibility between donors and patients for organ and bone marrow transplantation. HLA typing on the 3500 Dx offers labs an optimized, streamlined workflow with higher resolution than other molecular HLA typing technologies such as sequence-specific oligonucleotide (SSO) methods.
"With clearance of this system, transplant patients can now have the confidence that their HLA tissue typing was performed utilizing a thoroughly tested, high resolution technique that has passed the strict test requirements of the FDA," said Ronnie Andrews, president of medical sciences at Life Technologies. "Precise HLA matching between donor and patient significantly improves overall transplant survival."
The 3500 Dx is now the only 510(k)-cleared Sanger sequencer commercially available for the diagnostics market. Sanger, also known as capillary electrophoresis, sequencing is the technology that powered the Human Genome Project and remains the "gold-standard" for its accuracy, reliability and ease of use. It is expected that clearance will facilitate development of additional assays using the 3500 Dx and open up new partnerships with assay developers.
"Sanger sequencing remains the gold standard for providing the reliable results clinical labs need, and 510(k) clearance of the 3500Dx will help to establish sequencing technology as a mainstay of the hospital lab," said Andrews. "The instrument was designed with the clinical laboratory in mind, featuring a novel design that incorporates the ability to track patient samples with radio frequency identification (RFID) tags, as well as redesigned data collection and analysis software."
Products included in the current 510(k) clearance are the 3500 Dx/3500xL Dx Genetic Analyzers CS2; 3500 Dx Series Data Collection Software v1.0; SeCore® HLA Sequencing Kits; and uTYPE® Dx HLA Sequence Analysis Software. The 3500 Dx instrument is CE-marked for in vitro diagnostic use in Europe, has been approved by China's State Food and Drug Administration (SFDA) for diagnostic use in China, and is also available in Japan, Australia, India, New Zealand, Singapore, and Taiwan.
Additional products offered by Life Technologies for the diagnostics lab market include: the Applied Biosystems QuantStudio™ Dx Real-Time PCR Instrument, which is CE-IVD marked for use in Europe and under review by FDA; the Veriti™ Dx Thermal Cyclers; and the AcroMetrix® line of quality controls for molecular diagnostic assays. In addition, the EZ Validation™ Online Tool is available for assisting in the validation and verification of molecular tests.
Novo Nordisk (NYSE: NVO) announced on February 8th, 2013 it received a Complete Response Letter from the US Food and Drug Administration (FDA) regarding the New Drug Applications for Tresiba ® (insulin degludec) and Ryzodeg ® (insulin degludec/insulin aspart). A Complete Response Letter is issued by the FDA, when the agency determines that an application cannot be approved in its current form. In the letter, the FDA requests additional cardiovascular data from a dedicated cardiovascular outcomes trial before the review of the New Drug Applications can be completed. Novo Nordisk is evaluating the content of the Complete Response Letter and will work closely with the FDA to provide the requested data.
Novo Nordisk does not expect to be able to provide the requested data during 2013. In the letter, the FDA also states that approvals for Tresiba ® and Ryzodeg ® cannot be granted until the violations cited in the previously announced Warning Letter, dated 12 December 2012, have been resolved. “We are convinced that Tresiba ® and Ryzodeg ® offer significant benefits for people who require insulin”, said Lars Rebien Sørensen, chief executive officer of Novo Nordisk. “We are surprised and disappointed to receive this letter, but we acknowledge this decision by the FDA and will work with the agency to determine the best path forward to completing the review.” The New Drug Applications for Tresiba ® and Ryzodeg ® were submitted by Novo Nordisk to the FDA in September 2011.
In November 2012, at an FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting, a panel of independent scientific experts unanimously recommended that a cardiovascular outcomes trial should be conducted and voted eight to four in favour of approving the products with a post-approval cardiovascular outcomes trial commitment. Tresiba ® and Ryzodeg ® are approved in Japan, the EU and Mexico and under regulatory review in a number of countries throughout the world. The Complete Response Letter is not expected to significantly impact Novo Nordisk's expectations for the company's financial results for 2013, which were provided on 31 January 2013 in connection with the release of the financial results for 2012.
Advanced Cell Technology, Inc.’s (OTCBB: ACTC), clinical partner, the University of California, Los Angeles (UCLA), has received approval of its Investigator Investigational New Drug (IND) Application with the US Food and Drug Administration (FDA), led by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at UCLA and retina division chief at UCLA's Jules Stein Eye Institute, to initiate a Phase I/II study using ACT’s retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs) to treat myopic macular degeneration (MMD, or myopia), commonly known as nearsightedness.
Aethlon Medical, Inc. (OTC: AEMD), announced today that their February 7th RetailInvestorConferences.com presentation is now available for on-demand viewing.
Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE), a biopharmaceutical company focused on developing drugs to treat prevalent inflammatory diseases, such as osteoarthritis (OA) and diabetic macular edema (DME), announced the incorporation and initiation of operations of Luoxis Diagnostics, a subsidiary of Ampio that will initially be funded through a private placement, with Ampio maintaining approximately 80% ownership post financing.
AMRI (NASDAQ: AMRI) announced today that it has signed an exclusive license agreement with Chai Therapeutics, LLC for the development of ALB 109564(a), AMRI's novel tubulin inhibitor compound in late Phase I testing for the treatment of cancer.
BioClinica®, Inc. (NASDAQ: BIOC), a leading global provider of clinical trial management solutions and JLL Partners, Inc. (“JLL”), a leading private equity investment firm, announced today that BC Acquisition Corp. (“Purchaser”), which is a wholly-owned subsidiary of BioCore Holdings, Inc. (“Parent”), each of which is an affiliate of JLL, has commenced a tender offer for all outstanding shares of BioClinica at a price of $7.25 per share net to the seller in cash.
Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that REVLIMID® (lenalidomide) has been granted full approval, which includes an Import Drug License (IDL) by the China State Food and Drug Administration (SFDA) for use in combination with dexamethasone as a treatment for patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.
Covidien (NYSE: COV), a leading global provider of healthcare products, will present at the Leerink Swann 2013 Global Healthcare Conference in New York, New York, on February 14, 2013.
DARA BioSciences, Inc. (NASDAQ: DARA) (the "Company" or "DARA"), a specialty pharmaceutical company focused on oncology and oncology supportive care products, announced today the Company will be presenting at the 15th Annual BIO CEO & Investor Conference. Hosted by the Biotechnology Industry Organization (BIO), the 15th Annual BIO CEO & Investor Conference will take place February 11-12 at the Waldorf-Astoria in New York City.
Emergent BioSolutions Inc. (NYSE: EBS) announced today that a member of the company’s senior management team will provide a corporate overview presentation at the Cowen and Company 33rd Annual Health Care Conference in Boston on Monday, March 4, 2013 at 3:30PM Eastern.
Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) announced today that their February 7th RetailInvestorConferences.com presentation is now available for on-demand viewing.
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today announced the promotion of Mark Currie, Ph.D. to senior vice president, chief scientific officer (CSO), and president of research and development (R&D).
LifeMap Sciences, Inc., a subsidiary of BioTime, Inc. (NYSE MKT:BTX), announced today that according to Google Analytics, the Company’s databases have attracted over two million unique visitors in the previous 12 months.
Life Technologies Corporation (NASDAQ: LIFE) today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its 3500 Dx Genetic Analyzers and SeCore® HLA typing kits.
MiMedx Group, Inc. (OTCBB: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today its receipt of four new issued patents related to tissue grafts derived from the placenta.
MMRGlobal, Inc. (OTCQB: MMRF) ("MMR") and Fairway Physicians Insurance Company, RRG ("Fairway") jointly announced today that MMR has agreed to provide Fairway the ability to offer hospital malpractice insurance clients a prepaid license for the use of its MyMedicalRecords, Inc. Patent Portfolio.
NanoViricides, Inc. (OTC BB: NNVC) (the "Company") announced today that its President, Dr. Anil Diwan, will present an overview of the company at the 15th Annual BIO CEO and Investor Conference.
Perrigo Company (Nasdaq: PRGO; TASE) today announced that it has signed a definitive merger agreement and has completed the acquisition of Leeds, U.K.-based Rosemont Pharmaceuticals Ltd. ("Rosemont") for approximately £180 million or $283 million in cash.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it received from Sanofi a notification under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) that Sanofi intends to acquire Common Stock of Regeneron through open market purchases and direct purchases from shareholders.
Sigma-Aldrich Corporation (NASDAQ: SIAL), will hold its Business Review with the financial community on Thursday, March 21, 2013 at 8:30 AM Central Time. Presenters will include: President & CEO, Rakesh Sachdev; EVP & CFO, Jan Bertsch; EVP & President, SAFC Commercial Markets BU, Gilles Cottier; EVP & President, Applied Markets BU, Frank Wicks; and EVP & President, Research Markets BU, Eric Green.
SurModics, Inc. (Nasdaq: SRDX), a leading provider of surface modification for medical devices, today introduced SurModics Serene™ lubricious coatings for endovascular medical devices.
Synageva BioPharma Corp. (Synageva) (NASDAQ:GEVA), a clinical stage biopharmaceutical company developing therapeutic products for rare diseases, today announced that the first patient initiated treatment in the ARISE trial (Acid Lipase Replacement Investigating Safety and Efficacy), a global, Phase 3, randomized, double-blind, placebo-controlled study of sebelipase alfa in children and adults with late onset lysosomal acid lipase deficiency (LAL Deficiency).
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today that Dr. Arie Belldegrun was appointed by the Board of Directors of Teva, at its meeting of February 5, 2013, to fill a vacancy on the Board effective immediately. Dr. Belldegrun's term of office will extend until Teva’s 2013 Annual Meeting of Shareholders.
Therapeutic Solutions International, Inc. (OTCQB: TSOI) announced today the appointment of Barry Glassman, D.M.D., as Vice President of Training and Education.
Unilife Corporation (NASDAQ: UNIS, ASX: UNS), a U.S. based designer, developer and supplier of injectable drug delivery systems, today announced it will exhibit at the Pharmapack Europe Annual Meeting in Paris, France between February 13th and 14th.
YaFarm Technologies, Inc. (PINKSHEETS: YFRM) (YaFarm, or the Company) announced today the appointment of top level management for the Integrative Stem Cell Institute (ISCI), a premier provider of point-of-care, stem cell-based therapies.
Good news!! my new biospies are benign:) yayyyyyyyyyyyyyyyy
party time!!!
ACTC -ACT’s Clinical Partner Receives FDA Approval to Initiate Clinical Trial Using the Company’s hESC-derived Cells to Treat Severe Myopia
UCLA’s Investigator IND Application for Embryonic Stem Cell-Based Clinical Trial to Evaluate Safety and Tolerability in Patients with Severe Myopia, or Nearsightedness, Approved by FDA
Symbol Price Change
ACTC 0.0783
MARLBOROUGH, Mass.--(BUSINESS WIRE)--
Advanced Cell Technology, Inc.’s (“ACT”; OTCBB: ACTC or the “Company”), clinical partner, the University of California, Los Angeles (UCLA), has received approval of its Investigator Investigational New Drug (IND) Application with the US Food and Drug Administration (FDA), led by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at UCLA and retina division chief at UCLA's Jules Stein Eye Institute, to initiate a Phase I/II study using ACT’s retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs) to treat myopic macular degeneration (MMD, or myopia), commonly known as nearsightedness. The primary focus of the study will be to evaluate the safety in patients with severe myopia of the type that causes fissures in the RPE layer of the eye. Dr. Schwartz is the principal investigator in each of ACT’s two Phase I/II clinical trials for Stargardt's macular dystrophy and dry age-related macular degeneration (dry AMD) using RPE cells derived from hESCs. The approval was announced by Dr. Schwartz in his presentation at Bascom Palmer Eye Institute’s tenth annual angiogenesis meeting, “Angiogenesis, Exudation, and Degeneration 2013,” on Saturday, February 9 in Miami, Fla.
“We are encouraged by Dr. Schwartz’s keen interest in the evaluation of ACT’s RPE cells in potentially treating myopia,” commented Gary Rabin, chairman and CEO of ACT. “We are pleased to be on track to broaden the scope of our RPE program with the initiation of the new Investigator IND. Nearsightedness is a very common condition, worldwide, and it is estimated that roughly 30% of cases are high, or severe, myopia.”
The myopia clinical trial will follow a similar protocol as the company’s three other human clinical trials in the U.S. and Europe using hESC-derived RPE cells to treat forms of macular degeneration. The trial will enroll a total of 12 patients, with cohorts of three patients in an ascending dosage format. The trial is a prospective, open-label study designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with myopia at 12 months, the study’s primary endpoint.
Preliminary results from the U.S. Stargardt’s and Dry Age Related Macular Degeneration trials were reported in The Lancet earlier this year.
“We look forward to initiating the clinical trial,” commented Dr. Schwartz. “Myopic degeneration is an increasingly important global cause of permanent central vision loss for which there is no accepted treatment. Applying our key learnings from the ongoing ACT-sponsored stem cell trials allows the research promise of regenerative medicine to include myopic vision loss.”
Robert Lanza, M.D., ACT’s chief scientific officer, commented, “Myopia is one of the most common medical ailments in the world and myopic patients have a higher risk of permanent vision loss due to complications such as fissures in the RPE layer of the eye. We are anticipating Dr. Schwartz’s evaluations, potentially leading to a treatment for those patients at high risk of vision loss from this condition.”
About Advanced Cell Technology, Inc.
Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit www.advancedcell.com.
About the Jules Stein Eye Institute at UCLA
Established in 1966, the Jules Stein Eye Institute at UCLA represents the culmination of a dream shared by ophthalmologist, businessman and philanthropist Dr. Jules Stein and his wife, Doris, of creating a world-renowned center dedicated to the preservation of vision and the prevention of blindness. The Institute’s comprehensive programs for the care of patients with eye disorders, research in the vision sciences, education in the field of ophthalmology and outreach to the community, coupled with its state-of-the art facilities, have brought national and international recognition to UCLA and the Institute, as it continues its mission to advance ophthalmology worldwide.
Forward-Looking Statements
Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the company’s periodic reports, including the report on Form 10-K for the year ended December 31, 2011. Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Company’s clinical trials will be successful.
Contact:
ACT:
Investors:
CEOcast, Inc.
James Young, 212-732-4300
or
Press:
ACT Corporate Communications
Bill Douglass, 646-450-3615
or
Russo Partners
Martina Schwarzkopf, Ph.D., 212-845-4292
or
UCLA:
Jules Stein Eye Institute
Elaine Schmidt, 310-794-2272
eschmidt@mednet.ucla.edu
CMXI Announces Approval of Angel cPRP System in Australia
Symbol Price Change
CMXI 0.6775
GAITHERSBURG, MD--(Marketwire - Feb 11, 2013) - Cytomedix, Inc. ( OTCQX : CMXI ) (the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today that its Angel cPRP System has been listed by the TGA (Therapeutic Goods Administration) in Australia. Angel will be marketed and distributed by Medtel, a leading supplier of medical equipment and devices in Australia.
Australia is the latest international territory where the Angel System is now included and available for sale. The Angel is also on the market in various countries throughout Europe and the Middle East. Cytomedix has established a broad network of experienced distributors to promote and sell the product in international markets. Further territory launches are expected in 2013.
"We are pleased to launch Angel in Australia where there is significant growth potential for PRP," said Martin Rosendale, Chief Executive Officer of Cytomedix. "Sales in international markets are a meaningful contributor to overall Angel revenues, and are growing at an encouraging rate. We are fortunate to be working with Medtel as they have an excellent track record in launching and promoting innovative healthcare technology products."
Jeannie Devereaux, Business Development Manager, Regenerative Medicine Sports, Orthopedic & Tissue Regeneration, at Medtel, added, "We view the Angel cPRP System as the gold standard in platelet rich plasma preparation and expect a positive response to our Angel launch activities. TGA inclusion provides us with a great opportunity to develop the PRP market in aesthetics and sports medicine."
The Angel cPRP System is intended to be used in the clinic or intraoperatively at the point-of care for the safe and rapid preparation of platelet rich plasma (PRP). The initial approved indication in Australia is for the preparation of PRP from a sample of whole blood. The system is designed to produce consistently high platelet yields using a fully automated process. Angel's advantages compared with other commercially available systems include: 1) high platelet yields, 2) significant reduction in pro-inflammatory cells, 3) rapid processing time, 4) adjustable hematocrit from 0%-25%, and 5) flexible final cPRP volumes. Proprietary software automatically adjusts the separation parameters to deliver a consistent, high quality product.
About Cytomedix, Inc.
Cytomedix, Inc. is an autologous regenerative therapies company commercializing innovative platelet technologies for orthopedics and wound care with a pipeline of adult stem cell therapies for tissue repair. The Company markets the AutoloGel™ System, a device for the production of autologous platelet rich plasma ("PRP") gel for use on a variety of exuding wounds and the Angel® Concentrated Platelet Rich Plasma System, a blood processing device and disposable products used for the separation of whole blood into red cells, platelet poor plasma ("PPP") and PRP in surgical settings. On February 8, 2012 Cytomedix closed the acquisition of Aldagen, a biopharmaceutical company developing regenerative cell therapies based on its proprietary ALDH bright cell technology, currently in a Phase 2 trial for the treatment of ischemic stroke. For additional information please visit cytomedix.com.
Safe Harbor Statement
Statements contained in this press release not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix' actual results may differ materially due to a number of factors, many of which are beyond Cytomedix' ability to predict or control, including among many others, risks and uncertainties related to the Company's ability to successfully integrate the Aldagen acquisition, to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and integrated business enterprise, viability and effectiveness of the Company's sales approach and overall marketing strategies, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel™ System as contemplated. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as "believes," "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report for the year ended December 31, 2011 and other subsequent filings. These filings are available at www.sec.gov.
Contact:
Cytomedix, Inc.
Martin Rosendale
Chief Executive Officer
Andrew Maslan
Chief Financial Officer
David Jorden
Executive Chairman
(240) 499-2680
Michael Rice
Founding Partner
LifeSci Advisors LLC
646 597 6979
TGTX Opens Expansion Cohorts in Its Phase I/II Trial of TG-1101 (Ublituximab) in Patients With Rituximab Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
Cohort Expansion Now Open for Enrollment Following Early Signs of Clinical Activity
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Symbol Price Change
TGTX 3.75
NEW YORK, Feb. 11, 2013 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (TGTX) today announced that it has amended its Phase I/II study of single agent ublituximab to initiate its first expansion cohort following early signs of clinical activity. The protocol has been expanded to enroll up to 25 additional patients at the 900 mg dose level in the Phase I/II trial evaluating the safety, tolerability and efficacy of ublituximab, the Company's novel third-generation anti-CD20 monoclonal antibody, for patients with rituximab (Rituxan(R)) relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL). Dose escalation will continue as planned to the 1200 mg dose cohort. Following successful completion of the dose escalation component of the study, an additional expansion cohort may be added at the highest dose of 1200 mg.
The trial, entitled "An Open Label Phase I/II Trial of the Efficacy and Safety of Ublituximab in Patients with B-cell Non-Hodgkin Lymphoma who have Relapsed or are Refractory After CD20 Directed Antibody Therapy," (NCT01647971) has completed enrollment in 3 cohorts (450, 600 and 900mg) in the Phase I dose escalation component. All patients continue to be stratified by subtype of B-cell Lymphoma and all enrolled patients will be relapsed or refractory to Rituxan(R) or a Rituxan(R) containing regimen, and in most cases multiple other lines of therapy.
In addition to the cohort expansion, the study was amended to now allow enrollment of patients with Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL) as well as Primary Central Nervous System Lymphoma (PCNSL). Phase I data from a trial conducted in France with ublituximab administered as a single agent at a dose of 450 mg to relapsed and refractory CLL patients reported an objective response rate of 45%, with a manageable safety profile.
Dr. Owen O'Connor, Professor of Medicine and Director, Center for Lymphoid Malignancies at New York Presbyterian Columbia Medical Center, and the principal investigator of the trial stated "Ublituximab has been well-tolerated at all dose levels tested with no dose limiting toxicities seen to date. Coupled with the clinical activity seen in both rituximab relapsed and refractory patients across the dose levels tested thus far, we made the determination to expand the 900mg dose while we continue dose escalating. We look forward to expanding the study to better evaluate the safety and efficacy profile of ublituximab in multiple sub-types of B-cell malignancies."
"We are very excited about the early results from this first U.S.-based study of ublituximab in NHL. The early activity seen thus far, along with the activity seen in our Phase 1 study in patients with CLL, gives us a high degree of confidence that ublituximab is an active anti-CD20 monoclonal antibody for the treatment of B-cell malignancies," stated Michael S. Weiss, Executive Chairman and Interim CEO.
ABOUT TG-1101 (UBLITUXIMAB)
TG-1101 is a novel, third generation chimeric monoclonal antibody targeting a unique epitope on the CD20 antigen found on B-lymphocytes. TG-1101 has been bioengineered for enhanced biological activity with an increased ability to trigger an immune response, delivering superior ADCC effects to aid in B-cell depletion. TG-1101 has displayed high single agent activity in a Phase I/II clinical trial in patients with relapsed Chronic Lymphocytic Leukemia, and is being developed by TG Therapeutics for patients with various hematologic malignancies. TG-1101 has been granted orphan status in Europe and in the USA for B-cell Chronic Lymphocytic Leukemia.
ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is an innovative, clinical-stage biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of cancer and other underserved therapeutic needs. Currently, the company is developing two advanced therapies targeting hematological malignancies. TG-1101 (ublituximab) is a novel, third generation monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, a highly specific, orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B-lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies. TG Therapeutics is headquartered in New York City.
The TG Therapeutics logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=11857
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for TG-1101 and TGR-1202 and may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete pre-clinical and clinical trials for TG-1101 and TGR-1202; the risk that early clinical results that supported our decision to move forward into expansion cohorts will not be reproduced once additional patients are treated with TG-1101; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data produced from prior pre-clinical and clinical trials; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
TGTX - G
Contact:
Jenna Bosco
Director - Investor Relations
TG Therapeutics, Inc.
Telephone: 212.554.4484
Email: ir@tgtxinc.com
SRPT -Sarepta's eteplirsen accelerated approval could be denied, TheStreet.com reports According to TheStreet.com, accelerated approval for Sarepta's (SRPT) eteplirsen, a novel experimental drug for Duchenne Muscular Dystrophy, will be denied by the FDA. Instead, TheStreet says it is more likely Sarepta will be required to perform a larger pivotal study prior to submitting the drug for FDA review.
http://www.thestreet.com/story/11837371/1/sarepta-bear-speaks-eteplirsen-accelerated-approval-will-be-denied.html?cm_ven=GOOGLEN
you R so welcome, Let's Rock Boyz!!!!
BIOC -BioClinica announced that BC Acquisition, which is a wholly-owned subsidiary of BioCore Holdings each of which is an affiliate of JLL, has commenced a tender offer for all outstanding shares of BioClinica at a price of $7.25/share net to the seller in cash (BIOC) 7.22 : Co and JLL Partners ("JLL") announced that BC Acquisition Corp. ("Purchaser"), which is a wholly-owned subsidiary of BioCore Holdings ("Parent"), each of which is an affiliate of JLL, has commenced a tender offer for all outstanding shares of BioClinica at a price of $7.25 per share net to the seller in cash. The offer is being made pursuant to a definitive merger agreement pursuant to which Parent will acquire BioClinica.
Parent and Purchaser are affiliates of JLL Partners Fund VI, L.P. (the "Sponsor"), which is a private equity investment fund managed by JLL. The Board of Directors of BioClinica has unanimously approved and declared advisable the merger agreement and the transactions contemplated thereby, including the tender offer, declared that the merger agreement and the transactions contemplated thereby, including the tender offer, are fair to and in the best interests of BioClinica's stockholders, and recommended that BioClinica's stockholders accept the offer and tender their shares pursuant to the offer.
CELG -Celgene provides REVLIMID regulatory update; REVLIMID granted approval for treatment of patients with relapsed or refractory multiple myeloma in China (CELG) 100.13 : Co announced that REVLIMID has been granted full approval, which includes an Import Drug License by the China State Food and Drug Administration for use in combination with dexamethasone as a treatment for patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. The approval of REVLIMID is based upon the safety and efficacy results of multiple pivotal randomized phase III international clinical trials in patients with relapsed or refractory multiple myeloma.
CSBR Oncology Reports Successful Outcome From Technology Collaboration
Symbol Price Change
CSBR 0.59
HACKENSACK, N.J., Feb. 11, 2013 (GLOBE NEWSWIRE) -- Champions (CSBR) announced the successful completion of a TumorGraft technology collaboration with a subsidiary of Teva Pharmaceutical Industries, Ltd. ("Teva"). The collaboration was originally initiated in March of 2011 and included extensive evaluation of the efficacy and differentiation of CEP-32496, a dual B-Raf and EGFR inhibitor, one of Teva's proprietary late stage pre-clinical chemical compounds using 24 Champions TumorGraft(TM) models of B-Raf mutated human melanoma and colorectal cancer against standard of care drugs and targeted therapeutic agents. The results demonstrated that the compound met the predetermined success criteria. As part of the original agreement, Teva is obligated to pay Champions either milestone and royalty payments upon future development of the compound, or a one-time cash payment upon successful conclusion of the TumorGraft analysis. As a result of the successful outcome, Teva has exercised its right to make the one-time payment in the amount of $880,000 in lieu of the future payments.
Joel Ackerman, the CEO of Champions Oncology, commented, "We are excited about the positive outcome that our TumorGraft platform has delivered. This study validates the value that our TumorGrafts deliver to our clients and the importance they play in the process of oncology drug development."
About Champions Oncology, Inc.
Champions Oncology, Inc. is engaged in the development of advanced technology solutions and services to personalize the development and use of oncology drugs. The Company's TumorGraft Technology Platform is a novel approach to personalizing cancer care based upon the implantation of primary human tumors in immune deficient mice followed by propagation of the TumorGrafts in a manner that preserves the biological characteristics in order to determine the efficacy of a treatment regimen. The Company uses this technology to offer solutions for Personalized Oncology Solutions, which guides the development of personalized treatment plans, and Translational Oncology Solutions, which assists pharmaceutical and biotechnology companies seeking personalized approaches to drug development to lower the cost and increase the speed of drug development.
For more information, visit www.championsoncology.com.
This press release may contain "forward-looking statements" (within the meaning of the Private Securities Litigation Act of 1995) that inherently involve risk and uncertainties. Champions Oncology generally uses words such as "believe," "may," "could," "will," "intend," "expect," "anticipate," "plan," and similar expressions to identify forward-looking statements. One should not place undue reliance on these forward-looking statements. The Company's actual results could differ materially from those anticipated in the forward-looking statements for many unforeseen factors. See Champions Oncology's Form 10-K for the fiscal year ended April 30, 2012 for a discussion of such risks, uncertainties and other factors. Although the Company believes the expectations reflected in the forward-looking statements are reasonable, they relate only to events as of the date on which the statements are made, and Champions Oncology's future results, levels of activity, performance or achievements may not meet these expectations. The Company does not intend to update any of the forward-looking statements after the date of this press release to conform these statements to actual results or to changes in Champions Oncology's expectations, except as required by law.
Contact:
Gary Gemignani
Champions Oncology, Inc.
201-808-8408
GGemignani@championsoncology.com
Lauren Kwiecinski
The Trout Group LLC
646-378-2934
lkwiecinski@troutgroup.com
AMRI Signs Agreement for Exclusive License of its Tubulin Inhibitor Program for Cancer
Deal Affirms AMRI's Continued Efforts to Advance the Development of its Proprietary Programs
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AYM.F 4.465 -0.23
ALBANY, N.Y., Feb. 11, 2013 /PRNewswire/ -- AMRI (AMRI) announced today that it has signed an exclusive license agreement with Chai Therapeutics, LLC for the development of ALB 109564(a), AMRI's novel tubulin inhibitor compound in late Phase I testing for the treatment of cancer. This agreement follows the exercise of an option to license the intellectual property, which was granted in March 2012 by AMRI to Bessor Pharma, LLC, a translational drug development company. Chai Therapeutics is an affiliate of Bessor Pharma, LLC.
Under the terms of the license agreement, AMRI received an undisclosed license fee and reimbursement for certain costs associated with the intellectual property related to ALB 109564(a). Chai Therapeutics received an exclusive license to the ALB 109564(a) intellectual property, and will be solely responsible for all related research and development and patent costs going forward; AMRI will receive a share of future consideration from the further development and sales, if any, of any ALB 109564(a)-related drug that may be developed, licensed and/or commercialized.
"We are very pleased to continue to work with Bessor on the further development of AMRI's novel tubulin inhibitor," AMRI Chairman and CEO Thomas E. D'Ambra, Ph.D. said. "The recent formation of Chai Therapeutics to focus on the development of our compound is a strong statement by our partners of the potential benefit that this technology could ultimately deliver to cancer patients. Dr. Berkowitz and his team have a proven track record of success in drug development and we are confident in their ability to move this program forward."
D'Ambra continued, "The tubulin inhibitor program is an asset developed from our past R&D investments. As we have stated previously, we will continue to pursue strategic opportunities to enable AMRI to advance the clinical development of our other compounds and programs to create near- and long-term value for the company."
Barry A. Berkowitz, Ph.D., President and CEO of Bessor said, "In AMRI's work to date, ALB 109564(a) has shown significant promise as a next generation tubulin inhibitor for the treatment of cancer. Through our integrated network of drug development and clinical experts and the flexible structure afforded by Chai, we plan to advance the clinical program to further define the compound's potential. ALB 109564(a) is one of several translational projects in Bessor's growing portfolio that it is advancing to key value points."
AMRI has built a strong initial program around ALB 109564(a), providing an early indication that it may offer clinically relevant activity distinct from other tubulin inhibitors. This proprietary program, as well as AMRI's other available pipeline programs in the therapeutic areas of inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), cognitive impairment and schizophrenia, were each created with business strategies aimed at differentiating them from existing standards of care.
About ALB 109564(a) and Oncology
ALB 109564(a) is a novel analog from an established and marketed class of tubulin inhibitors, which is designed to kill cancer cells by preventing cell mitosis. The discovery of ALB 109564(a) leveraged AMRI's unique biocatalysis technology platform, natural products chemistry expertise, and high potency development capabilities. ALB 109564(a) has significant benefits compared with existing tubulin inhibitors in the same class. AMRI's Phase I study of ALB 109564(a) involved intravenous administration of ALB 109564(a) to cancer patients with advanced solid tumors. The study was designed to evaluate the compound's safety, tolerability, and pharmacokinetic profile and document effects on tumor growth. Previously announced results from the Phase I clinical dose-escalation study indicate that ALB 109564(a) is well tolerated at the doses tested and shows preliminary evidence of clinical activity in disease types not typically treated with approved vinca alkaloids.
About AMRI
Albany Molecular Research, Inc. (AMRI) is a global contract research and manufacturing organization offering customers fully integrated drug discovery, development and manufacturing services. For over 21 years, AMRI has demonstrated its adaptability as the pharmaceutical and biotechnology industries have undergone tremendous change in response to multiple challenges. This experience, a track record of success and locations in the United States, Europe and Asia now provides our customers with SMARTSOURCING™, a full range of value-added opportunities providing customers informed decision-making, enhanced efficiency and more successful outcomes at all stages of the pipeline. AMRI has also successfully partnered R&D programs and is actively seeking to out-license its remaining programs for further development. For more information about AMRI, please visit our website at www.amriglobal.com or follow us on Twitter (@amriglobal).
About Bessor Pharma and Chai Therapeutics
Bessor Pharma LLC and its affiliate, Chai Therapeutics, LLC, founded by a team of R&D and pharmaceutical business leaders, has created and is utilizing a new model for drug development and value creation, with a focus on translating drug discovery/development opportunities from universities and other organizations to key value points, typically IND readiness and for select projects, clinical proof-of-concept. The company has developed a flexible, project-oriented, capital efficient approach that attacks key drug development and financing challenges while advancing an innovative portfolio of product candidates. Bessor operates as a semi-virtual organization with a top team of pharmaceutical R&D and business experts and set of partners that function as a fully-integrated pharmaceutical network.
AMRI Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Readers should not place undue reliance on our forward-looking statements. The company's actual results may differ materially from such forward-looking statements as a result of numerous factors, some of which the company may not be able to predict and may not be within the company's control. Factors that could cause such differences include, but are not limited to: (a) Bessor Pharma's and Chai Therapeutics' ongoing ability to raise funding for the ALB 109564(a) research and clinical trial program; (b) problems or delays which may arise during clinical trials or in the course of developing, testing or manufacturing these compounds that could lead Bessor and Chai to discontinue development; (c) positive information about early stage clinical trial results is not necessarily indicative of clinical efficacy and does not ensure that later stage or larger scale clinical trials will be successful, for cancer or any other indication; (d) the planned timing of initiation and completion of clinical trials for ALB-109564(a) are subject to the ability of Bessor and Chai to enroll patients, enter into agreements with clinical trial sites and investigators, and other technical hurdles and issues that may not be resolved; (e) delay or denial of regulatory approvals from the FDA resulting from, among other things, adverse FDA decisions or interpretations of data that differ from AMRI, Bessor or Chai's interpretations and that may require additional clinical trials or potential changes in the cost, scope and duration of clinical trials; and those factors discussed in AMRI's Annual Report on Form 10-K for the year ended December 31, 2011 as filed with the Securities and Exchange Commission, and the company's other SEC filings. The company does not undertake any obligation to and does not intend to update any forward-looking statements contained in this press release.
ANX Initiates Thorough QT/QTc Clinical Study Of ANX-188
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ANX 0.74
SAN DIEGO, Feb. 11, 2013 /PRNewswire/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE MKT: ANX) today announced that it has initiated dosing in a thorough QT/QTc study (TQT study) of ANX-188.
Brian M. Culley, Chief Executive Officer, said: "Consistent with our guidance from October 2011 and our commitment to FDA, we have initiated this study before the end of the first quarter. We were pleased with the discussion we had with the Agency on the study protocol and our agreement on the supra-therapeutic dose."
Santosh Vetticaden, Chief Medical Officer, said: "The FDA requires an assessment of cardiac repolarization for most new drugs having systemic bioavailability. This study will assess whether or not ANX-188 has an effect on QT prolongation. The study should complete dosing in the first quarter, and we expect to announce results in the second quarter of 2013."
The objective of the TQT study is to evaluate the effect of therapeutic and supra-therapeutic doses of ANX-188 on cardiac ventricular repolarization, specifically the QT-interval, in healthy volunteers. The study is a single center, four-period, four-way cross-over, placebo- and positive-controlled, double-blind, randomized trial. Sixty subjects will be enrolled. Each subject will receive each of four treatments (placebo, active control, ANX-188 therapeutic dose, ANX-188 supra-therapeutic dose) during each of the four treatment periods.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a biopharmaceutical company developing proprietary product candidates to treat various diseases and conditions. The Company's lead product candidate, ANX-188, has potential to reduce ischemic tissue injury and end-organ damage by restoring microvascular function, which is compromised in a wide range of serious and life-threatening diseases and conditions. The Company is recruiting subjects in EPIC, a randomized, double-blind, placebo-controlled phase 3 study of ANX-188 in patients with sickle cell disease. More information can be found on the Company's web site at www.adventrx.com.
Forward Looking Statements
ADVENTRX cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that are based on ADVENTRX's current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements regarding the timing of completion and announcement of results of the TQT study. Among the factors that could cause or contribute to material differences between ADVENTRX's actual results and expectations indicated by the forward-looking statements are risks and uncertainties inherent in ADVENTRX's business, including, but not limited to: the potential for delays in the commencement or completion of clinical studies, including as a result of difficulties with opening trial sites or enrolling study subjects or being subject to a "clinical hold"; the risk of suspension or termination of a clinical study, including due to lack of adequate funding or patient safety concerns; ADVENTRX's reliance on contract research organizations (CROs) to conduct its clinical studies and on other third parties to assist with important aspects of its development and regulatory activities for ANX-188 and the potential for such third parties to fail to perform as expected or required; the risk that clinical studies, including EPIC and the TQT study, are not successfully executed and/or do not successfully demonstrate the safety or efficacy of the investigational drug; the risk that, even if clinical studies are successful, the FDA determines they are not sufficient to support a new drug application; the risk that even if clinical studies of an investigational drug in one indication are successful, clinical studies of the same investigational drug in another indication may not be successful; ADVENTRX's ability to obtain additional funding on a timely basis or on acceptable terms, or at all; the potential for ADVENTRX to delay, reduce or discontinue current and/or planned development activities, including clinical studies, partner its product candidates at inopportune times or pursue less expensive but higher-risk and/or lower-return development paths if it is unable to raise sufficient additional capital as needed; the risk that the FDA does not grant marketing approval of ADVENTRX's product candidates, including ANX-188, on a timely basis, or at all; and other risks and uncertainties more fully described in ADVENTRX's press releases and periodic filings with the Securities and Exchange Commission. ADVENTRX's public filings with the Securities and Exchange Commission are available at www.sec.gov.
You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. ADVENTRX does not intend to revise or update any forward-looking statement set forth in this press release to reflect events or circumstances arising after the date hereof, except as may be required by law.
GM lucas, thank you for the warm welcome. Diva does love her bios for sure!
GEVA initiates dosing in Phase 3 Sebelipase Alfa trial
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GEVA 48.22
LH 90.24
Synageva BioPharma (GEVA) announced that the first patient initiated treatment in the ARISE trial, a global, Phase 3, randomized, double-blind, placebo-controlled study of sebelipase alfa in children and adults with late onset lysosomal acid lipase deficiency. The ARISE trial will enroll 50 patients with late onset LAL Deficiency. Patients enrolled in the trial are randomized on a one-to-one basis to every other week infusions of sebelipase alfa, or placebo for the double-blind treatment period of 20 weeks. The primary endpoint of the trial is the proportion of patients relative to placebo who achieve normalization of alanine aminotransferase, a marker of liver damage, at the completion of the double-blind treatment period. Key secondary endpoints include the relative reduction from baseline to week 20 in LDL-C, non-HDL-C, triglycerides, the proportion of patients who achieve aspartate aminotransaminase normalization, and the relative increase in HDL-C. Additional secondary endpoints, including reductions in liver fat content and liver volume and improvements in liver pathology, will be examined in a proportion of patients who undergo these assessments. Deficiency of LAL enzyme activity will be confirmed during patient screening with a dried blood spot biochemical enzyme activity assay performed by Laboratory Corporation of America Holdings (LH), the central diagnostic testing laboratory performing the tests.
UnitedHealth Group (UNH) unit Optum Logistics Health has been awarded a U.S. Department of Defense contract to serve the health needs of members of the U.S. Armed Forces through the Reserve Health Readiness Program. The Reserve Health Readiness Program is a Department of Defense program managed by the Office of the Deputy Assistant Secretary of Defense for Force Health Protection and Readiness.
SGYP to begin trading on the NASDAQ Global Market on February 12 () 5.99 :Synergy Pharma
NVO -Novo Nordisk A/S receives Complete Response Letter in the US for Tresiba and Ryzodeg (NVO) 192.29 : Co announces that it received a Complete Response Letter from the FDA regarding the New Drug Applications for Tresiba and Ryzodeg. In the letter, the FDA requests additional cardiovascular data from a dedicated cardiovascular outcomes trial before the review of the New Drug Applications can be completed.
Novo Nordisk is evaluating the content of the Complete Response Letter and will work closely with the FDA to provide the requested data. Novo Nordisk does not expect to be able to provide the requested data during 2013.
In the letter, the FDA also states that approvals for Tresiba and Ryzodeg cannot be granted until the violations cited in the previously announced Warning Letter, dated December 12, 2012, have been resolved.
Watching, think it's time for some Diva dd to be done here
Marked the board
Cheer's
Very nice board:) marked and watching
Cheer's
diva
thank you:) have an awesome day
yummy, i'd like to try Kona Jo:)
#185:) cheer's
BIO updates Friday February 8, 2013
POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, presented data from the combined results of two Phase 3 studies of PA32540, an antiplatelet therapy of enteric-coated (EC) and immediate-release omeprazole, in patients with previous cerebrovascular disease. These data were presented at the American Heart Association 2013 International Stroke Conference on Thursday, February 7 at 4:15 p.m. (HST) in Honolulu, Hawaii at the Hawaii Convention Center as poster board number MP103.
According to the studies, in the post-hoc analysis of subjects with a history of transient ischemic attack (TIA) or stroke, long-term (6 months) treatment with PA32540, compared to EC-ASA (325 mg), was associated with a significantly reduced rate of endoscopic gastroduodenal ulcers (2.0% vs. 12.4% respectively; p=0.005), and study discontinuation due to adverse pre-specified upper GI events (0% vs. 8.0% respectively; p=0.006). The incidence of adjudicated major adverse cardiac events was similar for PA32540 (2.9%) and EC-ASA (325 mg) (4.4%).
“Discontinuation of aspirin therapy is often due to the adverse GI effects of aspirin,” said Mark J. Alberts, MD, UT Southwestern Medical Center, Dallas, Texas. “In these pivotal studies, PA32540 was associated with a significantly lower rate of treatment discontinuation than aspirin alone. Patient adherence to aspirin therapy saves lives, as aspirin discontinuation increases the likelihood of potential adverse cardiovascular and cerebrovascular events.”
AHA guidelines state that the use of an antiplatelet agent, such as aspirin, is recommended to reduce risk of recurrent stroke and other cardiovascular events.
St. Jude Medical, Inc. (NYSE: STJ), a global medical device company, announced the presentation of additional data from its landmark RESPECT trial at the American Stroke Association's International Stroke Conference 2013 in Honolulu. The RESPECT trial evaluated whether closing an opening in the heart, called a patent foramen ovale or PFO, with the AMPLATZER^™ PFO Occluder lowered the patient's risk of having another stroke.
“Data from the RESPECT trial indicates that patients with a device were less likely to suffer stroke, had smaller strokes, and were less likely to have the type of stroke linked to paradoxical embolism,” said Dr. Jeffrey L. Saver, director of the UCLA Stroke Center and professor of Neurology at the David Geffen School of Medicine. “Indications of preventing strokes on the surface of the brain and large strokes provide additional evidence of a genuine biological effect of closure with the AMPLATZER PFO Occluder in preventing recurrent cerebral infarcts due to a blood clot crossing through the PFO.”
An ischemic stroke occurs when a blood clot blocks a vessel, interrupting blood flow to an area of the brain (the other type of stroke is hemorrhagic, which occurs when a blood vessel in the brain ruptures). When a blood clot blocks a vessel, brain cells begin to die and brain damage can occur. The origin of the blood clot can impact where it becomes lodged in the brain, thereby creating strokes in different areas. A paradoxical embolism occurs when a blood clot travels from the right side of the heart to the left side of the heart, often through a PFO, and can then travel directly to the brain, causing an ischemic stroke. Statistics from the World Health Organization show an estimated 15 million strokes occur worldwide each year, of which approximately 80 percent are ischemic.
The purpose of analyzing these additional data from the RESPECT trial was to determine if patients in the device and medical therapy group suffered different types of recurrent strokes, and to identify the potential origin of the strokes. The results confirm that patients with a device in place were less likely to suffer another stroke and patients in the medical group experienced larger strokes. PFO closure with the AMPLATZER PFO Occluder demonstrates clinical evidence of risk reduction and is an important option for the prevention of recurrent stroke in carefully selected patients over conventional medical management alone.
“The overall trial demonstrates that PFO closure with the AMPLATZER PFO Occluder for these relatively young, otherwise healthy patients substantially reduces their risks of suffering another stroke,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division.
3SBio Inc. (NASDAQ: SSRX) ("3SBio" or the "Company"), a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced that it has entered into an agreement and plan of merger (the "Merger Agreement") with Decade Sunshine Limited, an exempted company with limited liability incorporated under the laws of the Cayman Islands ("Parent"), and Decade Sunshine Merger Sub, an exempted company with limited liability incorporated under the laws of the Cayman Islands and a direct wholly owned subsidiary of Parent ("Merger Sub").
Amarantus BioScience, Inc. (OTCQB: AMBS), a biotechnology company discovering and developing treatments and diagnostics for diseases associated with the neurodegeneration and apoptosis centered around its patented therapeutic protein MANF, today announced that Gerald E. Commissiong, President and Chief Executive Officer will present a corporate update at the 15th Annual BIO CEO & Investor Conference hosted by the Biotechnology Industry Organization (BIO).
Amgen (NASDAQ: AMGN) today announced the call for nominations for Breakaway from Cancer® Champions.
Anthera Pharmaceuticals, Inc.(Nasdaq: ANTH) a biopharmaceutical company developing drugs to treat serious diseases associated with inflammation and autoimmune disorders, today announced Paul F. Truex, Anthera's President and Chief Executive Officer, will present at the 2013 Leerink Global Healthcare Conference in New York, NY on Thursday, February 14, 2013 at approximately 8:00 am Eastern Time.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced that it will present at the Leerink Swann Global Healthcare Conference being held in New York City.
Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum (Sobi) (STO: SOBI) released data that confirmed the ability of investigational recombinant factors VIII Fc fusion protein (rFVIIIFc) and IX Fc fusion protein (rFIXFc) to provide long-lasting protection from bleeding with fewer injections than are required with the current standard of care for people with hemophilia.
Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that it has settled all pending litigation with Shire LLC and Shire Laboratories, Inc. (collectively Shire) relating to supply of its authorized generic Adderall XR® under the parties’ License and Distribution Agreement that was signed in January 2006.
Insulet Corporation (NASDAQ: PODD), the leader in tubeless insulin pump technology with its OmniPod® Insulin Management System, announced plans to release its financial results for the fourth quarter and full year 2012 on February 27, 2013 after the close of the financial markets.
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that Ron Bentsur, the Company's Chief Executive Officer, will be presenting at the 15th Annual BIO CEO & Investor Conference, being held February 11-12, 2013, in New York City. Mr. Bentsur's presentation is scheduled to take place on Monday, February 11th, at 2:30 PM ET.
LiveWire Ergogenics, Inc. (OTCQB: LVVV) has provided a corporate update of the company's activities and accomplishments in 2012 during which LiveWire completed the transition from a private company to a fully reporting public company with audited financials.
Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced its financial results for the quarter and year ended December 31, 2012.
Oncolytics Biotech Inc. ("Oncolytics") (TSX: ONC) (NASDAQ: ONCY) today announced results examining percent overall tumour shrinkage data from its U.S. Phase 2 clinical trial in patients with squamous cell carcinoma of the lung (SCCLC) using intravenous administration of REOLYSIN® in combination with carboplatin and paclitaxel (REO 021).
OPKO Health, Inc. (NYSE:OPK), in response to statements regarding the sale of Company common stock by Mr. Adam E. Logal, OPKO’s Vice President, Chief Accounting Officer and Treasurer, would like to clarify that no other Company officer has exercised common stock options or sold any shares of Company common stock during the last twelve months and that the nominal exercise of 50,000 common stock options and sale of such common stock by Mr. Logal was done to address pressing family circumstances.
Parametric Sound Corporation (NASDAQ: PAMT), a leading innovator of audio technology and solutions, today announced financial results for its first fiscal quarter ended December 31, 2012.
Palatin Technologies, Inc. (NYSE-MKT: PTN) will announce its second quarter, fiscal year 2013 financial results on Thursday, February 14, 2013 before the open of the U.S. financial markets.
Palatin Technologies, Inc. (NYSE MKT: PTN) announced that it will be presenting at the 15th Annual BIO CEO & Investor Conference.
Shire plc (LSE: SHP, NASDAQ: SHPG), today announced the initiation of a Phase 3 study designed to evaluate the efficacy and safety of ABH001, its dermal substitute therapy, for the treatment of non-healing wounds in patients with Epidermolysis Bullosa (EB), a group of rare genetic skin disorders that begin to manifest at birth or early childhood and occur in approximately 19 per 1 million live births in the US.
SOHM, Inc. (PINKSHEETS: SHMN) was searching for a prestigious event for the U.S. launch of its flagship skincare product FoHM by SOHM™, a rejuvenating, cleansing, and clarifying facial foam powered by the proprietary formula of Salic2™.
Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today that its President and Chief Executive Officer, Christopher J. Schaber, PhD, will give a corporate presentation at the 2013 BIO CEO & Investor Conference on Tuesday, February 12, at 3:00 PM Eastern Standard Time.
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the presentation of additional data from its landmark RESPECT trial at the American Stroke Association’s International Stroke Conference 2013 in Honolulu.
Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced that it, its affiliate Sucampo AG, R-Tech Ueno, Ltd., Takeda Pharmaceutical Company Limited (Takeda), and certain affiliates of Takeda have filed a patent infringement lawsuit in the United States District Court for the District of Delaware against Anchen Pharmaceuticals, Inc., Par Pharmaceuticals, Inc. and Par Pharmaceutical Companies, Inc. (collectively, Anchen) related to an Abbreviated New Drug Application (ANDA) that Anchen filed with the U.S. Food and Drug Administration (FDA) to market a generic version of AMITIZA® (lubiprostone) oral capsules, 8 mcg and 24 mcg.
Taro Pharmaceutical Industries Ltd. (NYSE: TARO) (“Taro”) and Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) (together with its subsidiaries, “Sun Pharma”) announced today that they have mutually agreed to terminate their merger agreement, announced in August 2012, pursuant to which all shareholders of Taro (other than Sun Pharma and its affiliates) would have received a cash payment of $39.50 per share upon the closing of the merger.
Verisante Technology, Inc. (TSX VENTURE:VRS) (OTCQX:VRSEF) (FRANKFURT:V3T) (the "Company" or "Verisante"), a leader in cancer detection technology, announced today that it has retained Hamza Thindal Capital Corp. (the "Firm" or "Hamza Thindal") for investor relations to help broaden investor awareness via the Firm's established network of investors in North America, Europe and the Gulf/MENA Region.
WuXi PharmaTech (Cayman) Inc. (NYSE: WX), a leading pharmaceutical, biotechnology and medical device R&D outsourcing company with operations in China and the United States, today announced that it will release financial results for the fourth quarter of 2012 after the New York Stock Exchange closes on Thursday, March 7, 2013 (which will be Friday morning, March 8, 2013 Shanghai time).
YaFarm Technologies, Inc. (OTC Pink: YFRM) (YaFarm, or the Company) announced today that the Integrative Stem Cell Institute (ISCI), a premier provider of point-of-care, stem cell- based therapies, is initiating design and development of a new, world-class cell processing and culture laboratory in Cancun, Mexico.
#90 for you:)
Hi PS, thanks for stopping by:)
SCMP -Sucampo Pharma files patent infringement lawsuit against Anchen Pharmaceuticals and Par Pharmaceuticals (SCMP) 5.22 : Co announced that it, its affiliate Sucampo AG, R-Tech Ueno, Takeda Pharmaceutical (TKPYY) and certain affiliates of Takeda have filed a patent infringement lawsuit in the United States District Court for the District of Delaware against Anchen Pharmaceuticals, Par Pharmaceuticals, and Par Pharmaceutical related to an Abbreviated New Drug Application (ANDA) that Anchen filed with the FDA to market a generic version of AMITIZA (lubiprostone) oral capsules, 8 mcg and 24 mcg. The lawsuit claims infringement of six patents that are listed in the FDA's Orange Book and that are scheduled to expire between 2020 and 2027.
ONCY -Oncolytics Biotech announces additional positive REOLSYIN clinical trial data from Phase 2 Study in squamous cell carcinoma of the lung (ONCY) 3.57 : Co announced results examining percent overall tumour shrinkage data from its U.S. Phase 2 clinical trial in patients with squamous cell carcinoma of the lung (SCCLC) using intravenous administration of REOLYSIN in combination with carboplatin and paclitaxel (REO 021). The analysis examined percent best overall tumour changes between pre-treatment and up to six treatment cycles. Of 20 evaluable patients, 19 (95%) exhibited overall tumour shrinkage, (mean (20 patients): 33.7% shrinkage). "Based on these findings we intend to continue to look at REOLYSIN as a treatment for cancers of the lung and cancers that metastasize to the lung." The study enrolled patients with metastatic or recurrent squamous cell carcinoma of the lung. The primary endpoint of the study is objective tumour response rates, and the secondary objectives include progression free survival and overall survival. To date, the Company has observed nine partial responses (PR), nine stable disease (SD) and three progressive disease (PD) by RECIST criteria for a disease control rate (complete response (CR) + PR + SD)) of 86%. The study continues to enroll patients.
POZN -POZEN presents positive PA32540 Phase 3 data at the 2013 International Stroke Conference (POZN) 5.46 : Co presented data from the combined results of two Phase 3 studies of PA32540, an antiplatelet therapy of enteric-coated and immediate-release omeprazole, in patients with previous cerebrovascular disease. These data were presented at the American Heart Association 2013 International Stroke Conference on Thursday, February 7. According to the studies, in the post-hoc analysis of subjects with a history of transient ischemic attack (TIA) or stroke, long-term (6 months) treatment with PA32540, compared to EC-ASA (325 mg), was associated with a significantly reduced rate of endoscopic gastroduodenal ulcers (2.0% vs. 12.4% respectively; p=0.005), and study discontinuation due to adverse pre-specified upper GI events (0% vs. 8.0% respectively; p=0.006). The incidence of adjudicated major adverse cardiac events was similar for PA32540 (2.9%) and EC-ASA (325 mg) (4.4%). PA32540 is associated with a lower rate of endoscopic gastroduodenal mucosal injury with a similar cerebrovascular event profile as EC-ASA therapy. PA32540, a single tablet containing EC aspirin and IR omeprazole, has a lower rate of discontinuation and, hence, may improve long-term adherence to ASA therapy.
ETRM ReCharge Trial Demonstrates Statistically Significant Weight Loss in Obesity But Does Not Meet Predefined Efficacy Endpoints
Based on Compelling Data, Company Plans Pre-Market Approval (PMA) Application; Company to Host Conference Call Today, February 7, 2013, at 5:00 PM ET
Symbol Price Change
ETRM 2.84
ST. PAUL, MN--(Marketwire - Feb 7, 2013) - EnteroMedics Inc. ( NASDAQ : ETRM ), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced results from its randomized ReCharge Pivotal Trial of VBLOC® vagal blocking therapy for the treatment of obesity. The trial demonstrated a clinically meaningful and statistically significant excess weight loss (EWL) of 24.4% for VBLOC Therapy-treated patients, with 52.5% of patients achieving at least 20% EWL. The trial met its primary safety endpoint, though it did not meet its predefined primary efficacy measures.
As a result of the excellent safety and efficacy profile of VBLOC Therapy, EnteroMedics plans to move forward with a Pre-Market Approval (PMA) application with the U.S. Food and Drug Administration (FDA) in the second quarter of 2013.
"Even though we did not reach the predefined efficacy thresholds, data from the ReCharge trial clearly demonstrate VBLOC Therapy's positive effect on weight loss, while adding to an excellent safety record," said Mark B. Knudson, Ph.D., EnteroMedics' President and Chief Executive Officer. "Based on these compelling results, and the totality of our clinical experience with the Maestro System, which now includes more than 600 patients worldwide, we believe EnteroMedics is well positioned to deliver this novel therapy to people with obesity in the U.S. We are moving forward with a PMA application to the FDA, in addition to advancing our plans for pursuing other indications, including obesity-related diabetes and hypertension, outside the U.S."
"Coupled with excellent safety results, the weight loss results for individuals getting VBLOC Therapy in the ReCharge trial demonstrate an excellent benefit-to-risk equation," said Robin Blackstone, MD, FACS, FASMBS, surgeon and Medical Director of Scottsdale Healthcare Bariatric Center at Scottsdale Healthcare in Arizona and Clinical Associate Professor of Surgery at the University Of Arizona College Of Medicine and investigator for the ReCharge trial. "If approved, VBLOC will fill a significant gap in the treatment spectrum, offering a unique approach that supports a healthy lifestyle and addresses the lifelong challenges associated with obesity and its co-morbidities."
Results in Detail
The ReCharge Pivotal Trial of VBLOC Therapy is a prospective double-blind, sham-controlled clinical trial involving 239 randomized patients (233 implanted) at ten sites in the United States and Australia. Patients were surgically implanted with either a fully functional device with leads to the vagus nerve (treated) or a device without leads to the vagus nerve (sham control).
In the primary analysis (intent-to-treat) population (n=239), treatment patients achieved a 24.4% average EWL compared to 15.9% for sham control patients. This 8.5% difference demonstrated statistical superiority over sham control (p=0.002), but not super-superiority at the pre-specified 10% margin (p=0.705). In total, 52.5% of treatment patients had 20% or more EWL compared to 32.5% in the control group (p=0.004), and 38.3% of treatment patients had 25% or more EWL compared to 23.4% in the sham control group (p=0.02). While the respective co-primary endpoint targets of 55% and 45% were not met, the endpoint targets were within the 95% confidence intervals for the observed rates and therefore the observed rates were not significantly lower than these pre-specified rates. These efficacy data demonstrate VBLOC Therapy's positive effect on weight loss.
In the per protocol group, which included only those patients who received therapy per the trial design (n=211), the treatment patients had an average 26.3% EWL compared to 17.3% for the sham control group (p=0.003). In total, 56.8% of treated patients achieved at least 20% EWL, which was above the pre-defined threshold of 55%, compared to 35.4% in the sham control group (p=0.004). 41.8% of patients also achieved at least 25% EWL in this population, which is slightly less than the predefined threshold of 45%, compared to 26.2% in the sham control group (p=0.03).
The rate of device-related serious adverse events was 3.1% for the treatment arm, significantly lower than the threshold of 15% (p < 0.0001). The safety results also confirmed VBLOC Therapy had no adverse cardiovascular effect. An overall reduction in blood pressure and heart rate was also observed in the treatment arm. Approximately 93% of patients reached the 12 month assessment in the trial, consistent with a rigorously executed trial.
Conference Call and Webcast
EnteroMedics will host a conference call and live webcast to discuss the detailed findings of its ReCharge Pivotal Trial today, February 7, 2013, at 5:00 PM ET. The conference call will be accompanied by a slide presentation available at www.enteromedics.com. The conference call may be accessed by dialing (877) 280-7473 for domestic callers and (707) 287-9370 for international callers and providing conference ID number 88748024. A replay of the call will be available beginning February 7, 2013 through May 6, 2013, and may be accessed by dialing (855) 859-2056 for domestic callers and (404) 537-3406 for international callers.
The call will be webcast live and may be accessed by visiting EnteroMedics' website at www.enteromedics.com. Investors can access the webcast under "Events" in the "Investors" section of EnteroMedics' website. Please connect to EnteroMedics' website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary. A replay of the webcast will also be available immediately after the conclusion of the presentation.
About the ReCharge Pivotal Trial
The ReCharge Pivotal Trial is a randomized, double-blind, sham-controlled, multicenter pivotal clinical trial in 239 randomized patients (233 implanted) at 10 sites testing the effectiveness and safety of VBLOC® vagal blocking therapy utilizing EnteroMedics' second generation Maestro® Rechargeable (RC) System. All patients in the trial received an implanted device and were randomized in a 2:1 allocation to treatment or control groups. The control group received a non-functional device during the trial period. All patients are expected to participate in a weight management counseling program.
About Maestro Rechargeable (RC) System
The Maestro RC System delivers VBLOC® vagal blocking therapy via two small electrodes that are laparoscopically implanted and placed in contact with the trunks of the vagus nerve just above the junction between the esophagus and the stomach. The Maestro RC System is powered by an internal, rechargeable battery. The battery is recharged via an external mobile charger and transmit coil that the patient uses for a short time each week. The Maestro RC System has received CE Mark and has been listed on the Australian Register of Therapeutic Goods.
About VBLOC® Therapy
EnteroMedics developed VBLOC® vagal blocking therapy to offer bariatric surgeons and their patients a less invasive alternative to existing surgical weight loss procedures that may present significant risks and alter digestive system anatomy, lifestyle and food choices. VBLOC® Therapy is delivered via the Maestro® System through laparoscopically implanted leads to intermittently block the vagus nerves using high-frequency, low-energy electrical impulses. VBLOC® Therapy is designed to target the multiple digestive functions under control of the vagus nerves and to affect the perception of hunger and fullness.
About EnteroMedics Inc.
EnteroMedics is a medical device company focused on the development and commercialization of its neuroscience based technology to treat obesity and metabolic diseases. EnteroMedics' proprietary technology, VBLOC® vagal blocking therapy, delivered by a pacemaker-like device called the Maestro® Rechargeable System, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses. VBLOC allows people with obesity to take a positive path towards weight loss, addressing the lifelong challenge of obesity and its comorbidities without sacrificing wellbeing or comfort. EnteroMedics' Maestro Rechargeable System has received CE Mark and is listed on the Australian Register of Therapeutic Goods.
Forward-Looking Safe Harbor Statement:
This press release contains forward-looking statements about EnteroMedics Inc. Our actual results could differ materially from those discussed due to known and unknown risks, uncertainties and other factors including our limited history of operations; our losses since inception and for the foreseeable future; our lack of commercial regulatory approval for our Maestro® System for the treatment of obesity in the United States or in any foreign market other than Australia and the European Community; our preliminary findings from our EMPOWER™ and ReCharge pivotal trials; our ability to comply with the Nasdaq continued listing requirements; our ability to commercialize our Maestro System; our dependence on third parties to initiate and perform our clinical trials; the need to obtain regulatory approval for any modifications to our Maestro System; physician adoption of our Maestro System and VBLOC® vagal blocking therapy; our ability to obtain third party coding, coverage or payment levels; ongoing regulatory compliance; our dependence on third party manufacturers and suppliers; the successful development of our sales and marketing capabilities; our ability to raise additional capital when needed; international commercialization and operation; our ability to attract and retain management and other personnel and to manage our growth effectively; potential product liability claims; potential healthcare fraud and abuse claims; healthcare legislative reform; and our ability to obtain and maintain intellectual property protection for our technology and products. These and additional risks and uncertainties are described more fully in the Company's filings with the Securities and Exchange Commission, particularly those factors identified as "risk factors" in the annual report on Form 10-K filed March 15, 2012. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
Caution - Investigational device. Limited by Federal (United States) law to investigational use.
The implantation procedure and usage of the Maestro® System carry some risks, such as the risks generally associated with laparoscopic procedures and those related to treatment as described in the ReCharge clinical trial informed consent.
Contact:
Company
EnteroMedics Inc.
Greg S. Lea
(651) 789-2860
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Media
Sam Brown Inc.
Mike Beyer
(312) 961-2502
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