Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Keryx Biopharmaceuticals Receives Orphan Drug Designation for KRX-0401 (Perifosine) for the Treatment of Neuroblastoma
Date : 07/14/2010 @ 11:00AM
Source : PR Newswire
Stock : Keryx Biopharmaceuticals (MM) (KERX)
http://ih.advfn.com/p.php?pid=nmona&article=43601026&symbol=N^KERX
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that KRX-0401 (perifosine) has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of neuroblastoma, a cancer of the nervous system affecting mostly children and infants for which there are no FDA approved therapies.
Phase 1 data of perifosine in recurrent pediatric solid tumors, including neuroblastoma, was presented last month in the pediatric solid tumor poster discussion session held at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO). Investigators from the Memorial Sloan-Kettering Cancer Center concluded that perifosine was demonstrated to be safe and well tolerated in children with advanced solid tumors and that perifosine may have antitumor clinical activity as a single agent in neuroblastoma. Additionally, in a preclinical study recently published in the Journal of the National Cancer Institute, perifosine showed a statistically significant reduction in neuroblastoma cell survival, slowed or regressed tumor growth, and increased survival in mice bearing neuroblastoma tumors. A decreased level of activated Akt was also observed in perifosine-treated neuroblastoma cells and xenograft tumors.
Ron Bentsur, Chief Executive Officer of Keryx, commented, "The Orphan Drug designation is an important component of our development plan for perifosine in neuroblastoma, an indication where no FDA approved therapies currently exist." Mr. Bentsur continued, "We are currently exploring next steps for the development of perifosine in this indication which we hope, ultimately, could provide a new treatment option for children and infants suffering with neuroblastoma."
Perifosine is currently in Phase 3 clinical development for refractory advanced colorectal cancer and multiple myeloma, both of these Phase 3 programs being conducted under Special Protocol Assessment (SPA) agreements with the FDA with Fast Track designations obtained for both indications. Perifosine is also in Phase 1 and 2 clinical development for several other tumor types.
KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris, Inc. in the United States, Canada and Mexico.
About Orphan Drug Designation
Orphan drug designation is granted by the FDA Office of Orphan Drug Products to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity if the drug is the first of its type approved for the specified indication or if it demonstrates superior safety, efficacy, or a major contribution to patient care versus another drug of its type previously granted the designation for the same indication, as well as with tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and waiver of Prescription Drug User Fee Act (PDUFA) filing fees.
About Neuroblastoma
According to the American Cancer Society, neuroblastoma is the most common cancer in infants (less than 1 year old) and accounts for about 7% of all pediatric cancers. There are about 650 new cases of neuroblastoma each year in the United States, and, while in rare cases neuroblastoma is detected by ultrasound in utero, the average age at the time of diagnosis is approximately 1 to 2 years, with 90% of cases diagnosed before age 5. In about 2 of 3 cases, the disease has already spread (metastasized) to other parts of the body at the time of diagnosis and as a result, treatment options can be limited.
Neuroblastoma exhibits a wide range of behavior. Some infant neuroblastomas may just go away without treatment (spontaneously regress), while other neuroblastomas may be resistant to very intensive multimodal treatment, and, in these cases, neuroblastoma is considered to be one of the most aggressive and difficult to cure childhood cancers.
To date, no FDA approved therapies exist for the treatment of neuroblastoma. Chemotherapy is the mainstay of neuroblastoma treatment. The type of chemotherapy and its intensity are determined by the age of the patient and the extent of the disease (risk-factors). However, because these cancers can be hard to treat, additional therapies are needed in order to delay progression and extend survival.
ABOUT KERYX BIOPHARMACEUTICALS, INC.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. KRX-0401 is currently in Phase 3 clinical development for both refractory advanced colorectal cancer and multiple myeloma, and in Phase 1 and 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 programs are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. Keryx is also developing Zerenex(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex in the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to an SPA agreement with the FDA. Keryx is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for KRX-0401 (perifosine), 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 clinical trials for KRX-0401; the risk that the data (both safety and efficacy) from advanced clinical studies of KRX-0401 (perifosine) will not coincide with the data analyses from earlier pre-clinical and clinical studies reported by the Company; 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 http://www.keryx.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
KERYX CONTACT:
Lauren Fischer
Director, Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5962
SOURCE Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals Receives Orphan Drug Designation for KRX-0401 (Perifosine) for the Treatment of Neuroblastoma
Date : 07/14/2010 @ 11:00AM
Source : PR Newswire
Stock : Keryx Biopharmaceuticals (MM) (KERX)
http://ih.advfn.com/p.php?pid=nmona&article=43601026&symbol=N^KERX
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that KRX-0401 (perifosine) has received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of neuroblastoma, a cancer of the nervous system affecting mostly children and infants for which there are no FDA approved therapies.
Phase 1 data of perifosine in recurrent pediatric solid tumors, including neuroblastoma, was presented last month in the pediatric solid tumor poster discussion session held at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO). Investigators from the Memorial Sloan-Kettering Cancer Center concluded that perifosine was demonstrated to be safe and well tolerated in children with advanced solid tumors and that perifosine may have antitumor clinical activity as a single agent in neuroblastoma. Additionally, in a preclinical study recently published in the Journal of the National Cancer Institute, perifosine showed a statistically significant reduction in neuroblastoma cell survival, slowed or regressed tumor growth, and increased survival in mice bearing neuroblastoma tumors. A decreased level of activated Akt was also observed in perifosine-treated neuroblastoma cells and xenograft tumors.
Ron Bentsur, Chief Executive Officer of Keryx, commented, "The Orphan Drug designation is an important component of our development plan for perifosine in neuroblastoma, an indication where no FDA approved therapies currently exist." Mr. Bentsur continued, "We are currently exploring next steps for the development of perifosine in this indication which we hope, ultimately, could provide a new treatment option for children and infants suffering with neuroblastoma."
Perifosine is currently in Phase 3 clinical development for refractory advanced colorectal cancer and multiple myeloma, both of these Phase 3 programs being conducted under Special Protocol Assessment (SPA) agreements with the FDA with Fast Track designations obtained for both indications. Perifosine is also in Phase 1 and 2 clinical development for several other tumor types.
KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris, Inc. in the United States, Canada and Mexico.
About Orphan Drug Designation
Orphan drug designation is granted by the FDA Office of Orphan Drug Products to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity if the drug is the first of its type approved for the specified indication or if it demonstrates superior safety, efficacy, or a major contribution to patient care versus another drug of its type previously granted the designation for the same indication, as well as with tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and waiver of Prescription Drug User Fee Act (PDUFA) filing fees.
About Neuroblastoma
According to the American Cancer Society, neuroblastoma is the most common cancer in infants (less than 1 year old) and accounts for about 7% of all pediatric cancers. There are about 650 new cases of neuroblastoma each year in the United States, and, while in rare cases neuroblastoma is detected by ultrasound in utero, the average age at the time of diagnosis is approximately 1 to 2 years, with 90% of cases diagnosed before age 5. In about 2 of 3 cases, the disease has already spread (metastasized) to other parts of the body at the time of diagnosis and as a result, treatment options can be limited.
Neuroblastoma exhibits a wide range of behavior. Some infant neuroblastomas may just go away without treatment (spontaneously regress), while other neuroblastomas may be resistant to very intensive multimodal treatment, and, in these cases, neuroblastoma is considered to be one of the most aggressive and difficult to cure childhood cancers.
To date, no FDA approved therapies exist for the treatment of neuroblastoma. Chemotherapy is the mainstay of neuroblastoma treatment. The type of chemotherapy and its intensity are determined by the age of the patient and the extent of the disease (risk-factors). However, because these cancers can be hard to treat, additional therapies are needed in order to delay progression and extend survival.
ABOUT KERYX BIOPHARMACEUTICALS, INC.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. KRX-0401 is currently in Phase 3 clinical development for both refractory advanced colorectal cancer and multiple myeloma, and in Phase 1 and 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 programs are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. Keryx is also developing Zerenex(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex in the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to an SPA agreement with the FDA. Keryx is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for KRX-0401 (perifosine), 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 clinical trials for KRX-0401; the risk that the data (both safety and efficacy) from advanced clinical studies of KRX-0401 (perifosine) will not coincide with the data analyses from earlier pre-clinical and clinical studies reported by the Company; 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 http://www.keryx.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
KERYX CONTACT:
Lauren Fischer
Director, Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5962
SOURCE Keryx Biopharmaceuticals, Inc.
Paul the Octopus says long YRCW ??
Novelos Therapeutics Announces Positive Phase 2 Results in NOV-002 Neoadjuvant Breast Cancer Trial at Sylvester Comprehensive Cancer Center, at the University of Miami
Date : 07/12/2010 @ 8:30AM
Source : Business Wire
Stock : Novelos Therapeutics (NVLT)
http://ih.advfn.com/p.php?pid=nmona&article=43564943&symbol=NB^NVLT
Novelos Therapeutics, Inc. (OTCBB: NVLT), a biopharmaceutical company developing therapeutics to treat cancer and hepatitis, today announced positive results in a Phase 2 trial of NOV-002 in combination with neoadjuvant chemotherapy treatment in patients with stage IIB-IIIC HER-2/neu negative invasive breast cancer, conducted by the Braman Family Breast Cancer Institute at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine. Alberto Montero, MD, Assistant Professor of Medicine at the Miller School and medical oncologist at Sylvester, is the Principal Investigator.
This Phase 2 open-label, single-arm, Simon 2-Stage trial was designed to determine if preoperative administration of NOV-002 in combination with doxorubicin and cyclophosphamide followed by docetaxel (AC-T) results in at least a doubling in the rate of pathologic complete response (pCR) compared to a historical control. For NOV-002 to be declared active at the end of the trial, a minimum of 12 patients must achieve a pCR. This criterion of 12 pCRs has been met prior to all patients completing the trial. Patient enrollment continues and some patients are still in the NOV-002 treatment stage. Trial results have been submitted for presentation to the AACR Breast Cancer Symposium taking place in San Antonio, TX, in December 2010. The Phase 2 trial design can be found on www.clinicaltrials.gov – ID: NCT00499122, or via a link at www.novelos.com ‘Clinical Trials’ section.
“In this trial where now 39 breast cancer patients have been enrolled from three different hospitals we have 12 confirmed pathologic complete responses out of 31 patients (39%) who have undergone surgery, which is higher than what has been previously reported with preoperative chemotherapy, consisting of doxorubicin and cyclophosphamide followed by docetaxel, in HER-2 negative breast cancer patients,” said Dr. Montero. “By comparison the published pCR rate in several trials with an anthracycline followed by a taxane chemotherapy in patients with HER-2 negative breast cancer is in the range of 10-20%. We also continue to observe very high pCR rates in the breast cancer subtype least sensitive to chemotherapy, hormone receptor positive breast cancer, also known as luminal subtype, thus far we have confirmed pCR in approximately 11/26 (42%) of all ER+ pts. These results I believe provide preliminary data that further trials of NOV-002 plus chemotherapy in breast cancer are warranted.”
“We are very pleased that NOV-002 has demonstrated positive results in this Phase 2 neoadjuvant breast cancer trial,” said Harry Palmin, President and CEO of Novelos. “We look forward to working with Dr. Montero, Sylvester Comprehensive Cancer Center, as well as key opinion leaders and the FDA on a design for a possible larger randomized controlled trial in breast cancer.”
“The efficacy seen in this trial is of particular interest in relation to our growing understanding of NOV-002’s mechanism of action,” said Christopher Pazoles, Ph.D., Vice President of Research & Development of Novelos. “Recent findings suggest that, due to its anti-tumor immunomodulatory activities, NOV-002 may be particularly well-suited for combination with certain ‘immunogenic’ chemotherapy agents including cyclophosphamide and doxorubicin which are commonly used to treat breast cancer and are part of the treatment regimen used in this trial.”
About Breast Cancer
Breast cancer remains a serious public health concern throughout the world. According to the American Cancer Society, approximately 192,000 women in the U.S. were expected to be diagnosed with breast cancer in 2009, and approximately 41,000 were expected to die from the disease. Neoadjuvant or preoperative systemic chemotherapy is commonly employed in patients with locally advanced stage-III breast cancer and in some patients with stage-II tumors. Administration of neoadjuvant chemotherapy reduces tumor size, thus enabling breast conservation surgery in patients who otherwise would require a mastectomy. Furthermore, several studies have shown that pathologic complete response (pCR) following neoadjuvant chemotherapy is associated with a significantly higher probability of long-term survival. However, only a small fraction of patients with HER-2 negative breast cancer achieve a pCR with standard neoadjuvant chemotherapy.
About NOV-002 for Breast Cancer
Cytotoxic chemotherapy is generally regarded as immunosuppressive because of toxicity towards dividing cells in the bone marrow and peripheral lymphoid tissue. It is now understood, however, that some chemotherapeutic agents referred to as “immunogenic” may enhance the antitumor effects of immunotherapy by acting directly on the tumor and host environment. Immunogenic chemotherapy agents commonly used in the treatment of breast cancer include cyclophosphamide, anthracyclines (such as doxorubicin) and gemcitabine. NOV-002 is believed to act via generation of oxidative signals that mimic physiological regulatory mechanisms for a variety of redox-sensitive cell processes and functions. In tumors, this results in inhibition of cell proliferation and of tumor invasiveness/metastasis. Of particular interest in the context of breast cancer therapy, NOV-002 displays multiple forms of in vivo immunomodulation which, when combined with immunogenic chemotherapy, may increase anti-tumor efficacy. Thus, NOV-002 alone increased effector T cell responsiveness to tumor antigens and elevated levels of memory T cells in tumors and spleen in animal tumor models. When combined in such models with the immunogenic chemotherapy agent cyclophosphamide, NOV-002 increased survival and decreased tumor growth compared to chemotherapy alone. It also inhibited the activity of myeloid-derived T cell suppressor cells. Such data supports the hypothesis that the immunomodulatory activities of NOV-002 may enhance the anti-cancer efficacy of immunogenic chemotherapy such as that commonly used in treating breast cancer.
About Sylvester Comprehensive Cancer Center
Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine opened in 1992 to provide comprehensive cancer services and today serves as the hub for cancer-related research, diagnosis, and treatment at UHealth -- the University of Miami Health System. Sylvester handles nearly 1,600 inpatient admissions annually, performs 2,700 surgical procedures, and treats more than 3,700 new cancer patients. All Sylvester physicians are on the faculty of the Miller School of Medicine, South Florida’s only academic medical center. In addition, Sylvester physicians and scientists are engaged in more than 200 clinical trials and receive more than $36 million annually in research grants. Sylvester at Deerfield Beach opened in 2003 to better meet the needs of residents of Broward and Palm Beach counties. A major expansion has recently been completed. Deerfield Beach offers appointments with nearly 30 physicians from 12 of Sylvester’s 15 Site Disease Groups, complementary therapies from the Courtelis Center, and education and outreach events. www.sylvester.org
About Novelos Therapeutics, Inc.
Novelos Therapeutics, Inc. is a biopharmaceutical company developing oxidized glutathione-based compounds for the treatment of cancer and hepatitis. Our lead compound, NOV-002, has been administered to approximately 1,000 cancer patients in clinical trials and is in Phase 2 development for solid tumors in combination with chemotherapy. Novelos is seeking to expand our pipeline through licensing or acquiring clinical stage compounds or technologies for oncology indications. For additional information about Novelos please visit www.novelos.com
Novelos Therapeutics, Inc.
One Gateway Center, Suite 504
Newton, MA 02458
This news release contains forward-looking statements. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators’ ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement.
FDA to review first of 3 new weight loss drugs
FDA to evaluate obesity drug that would be the first new prescription treatment in a decade
Monday July 12, 2010, 8:21 am
http://finance.yahoo.com/news/FDA-to-review-first-of-3-new-apf-3053966257.html?x=0&sec=topStories&pos=main&asset=&ccode=
WASHINGTON (AP) -- Dieters, doctors and investors get their first extensive look at the first of a trio of new weight loss drugs this week. The hope is that the new drugs can succeed where many others have failed: delivering significant weight loss without risky side effects.
With U.S. obesity rates nearing 35 percent of the adult population, expectations are high for the first new prescription drug therapies to emerge in more than a decade. Even a modestly effective drug has blockbuster potential.
None of the three medicines represents a breakthrough in research. Drugmakers have made little headway in understanding and treating the causes of overeating. Two of the drugs submitted for approval simply combine existing drugs -- an anticonvulsant and an amphetamine -- but have worrying side effects. The third, a new medication, is safer but less effective.
The quest for a blockbuster weight loss drug has been plagued for decades by safety issues. The most notable was Wyeth's diet pill drug combination fen-phen, which was pulled off the market in 1997 due to links to heart valve damage and lung problems.
The FDA is expected to post its review of Vivus Inc.'s pill Qnexa on Monday and will hold a public meeting Thursday to review the data. Orexigen Therapeutics Inc.'s Contrave is set for review in October, and Arena Pharmaceuticals Inc.'s lorcaserin is set for December.
"There's no obvious clear winner," said Leerink Swann analyst Steve Yoo. "If you look at different aspects, each drug shines."
To be considered effective, obesity drugs should reduce total body weight by at least 5 percent after one year, according to FDA guidance to companies.
Qnexa showed the best weight loss results in clinical trials, with patients losing between 13 percent and 15 percent of their body weight. But the drug also had the highest rate of patient dropouts due to side effects, which include memory and concentration problems.
Qnexa is a combination of two older drugs: the amphetamine phentermine and topiramate, an anticonvulsant drug sold by Johnson & Johnson as Topamax. According to the company, phentermine helps suppress appetite, while topiramate makes patients feel more satiated.
Contrave is also a combination pill, mixing an antidepressant with an anticonvulsant drug. The drug has shown weight loss between 5 percent and 10 percent with side effects such as nausea.
University of Liverpool Professor Jason Halford said drug companies are taking a multi-pronged approach to obesity therapies because science has shown there are multiple brain signals that drive food intake.
"We're using combinations of old drugs with a very broad spectrum of pharmacotherapy, it's very much the shotgun approach," said Halford, a health psychologist who has consulted for drug companies on obesity treatments.
The one truly novel drug under FDA review showed the weakest results in clinical trials. Arena Pharmaceuticals' lorcaserin is a first-of-a-kind drug that acts on serotonin, a brain chemical associated with feelings of well-being and satiation. But patients in company trials lost just 5 percent of their body weight.
While Arena's drug trails its competitors in weight loss, it appears to have the least side effects, an important factor in FDA approval.
Investors clearly favor Vivus in the three-way race. Shares of Vivus have nearly doubled over the past year to close Friday at $11.52.
Arena Pharmaceuticals shares have fallen nearly 4 percent over the past year on lackluster results for its drug. Orexigen shares have fallen 21 percent over the past year, to close Friday at $4.17, marking a bouncy descent from a June 2007 peak of $17.70 a share.
Decision Resources, a drug industry analysis firm, believes all three drugs could eventually win approval and find a place in the global obesity market. The firm expects the global market to soar from $500 million to $3.4 billion a year by 2018.
Still, the history of diet drugs is littered with stumbling blocks.
The diet drug fenfluramine, which was half of the fen-phen combination, was withdrawn in 1997 after it was linked with heart damage. The drug's combination with phentermine was popular but never approved by FDA.
Two years ago Sanofi-Aventis SA discontinued studies of its highly anticipated pill Acomplia due to psychiatric side effects, including depression and suicidal thoughts.
Side effects have kept the small number of weight-loss drugs currently on the market from being blockbuster sellers. Abbott Laboratories' appetite suppressant Meridia was pulled from the market in Europe last November due to data showing increased heart attack risks. And in May, the FDA warned consumers that the over-the-counter weight loss pill alli, which has been sold for years at a higher dose as the prescription drug Xenical, could cause severe liver damage. The drug works by limiting the amount of fat the body can absorb.
Derek Lowe, a pharmaceutical researcher and blogger, says the new combination drugs under review hold promise because they work on multiple brain chemicals that drive overeating.
"No single agent is going to shut down this behavior," said Lowe, whose blog "In the Pipeline" focuses on drug development. "But if you can come in and hit two or more of these different pathways at the same time, maybe then you'll get somewhere."
Zoom Technologies Announces $1.5 Million R&D Investment by Datang Capital Management
Date : 07/12/2010 @ 8:00AM
Source : MarketWire
Stock : Zoom Technologies (ZOOM)
http://ih.advfn.com/p.php?pid=nmona&article=43564405&symbol=ZOOM
Zoom Technologies, Inc. (NASDAQ: ZOOM), a leading China based manufacturer of mobile phones and other mobile electronic products, announced today that its mobile phone design subsidiary, Nollec Wireless, has signed a non-binding memorandum of understanding with Datang Capital Management (Beijing) Company, Ltd. ("Datang Capital") for an investment of Rmb 10 million (approximately US$1.5 million) from Datang Capital into Nollec Wireless.
The cash injection is intended to be used for Nollec's further development of advanced mobile handsets and to expedite the commercialization of next generation features through the integration of user-friendly software applications with state-of-the-art hardware modules. Datang Capital is the investment company of Datang Telecom (Shanghai Stock Exchange: 600198), a Chinese telecommunication equipment vendor well recognized for its leading role in developing the Chinese TD-SCDMA 3G mobile telecommunications standard through subsidiary Datang Mobile. Terms of the investment are to be finalized in a definitive agreement.
Mr. Leo Gu, Chief Executive Officer of Zoom Technologies, said, "Datang's intended investment in our research arm is a significant endorsement of our R&D and manufacturing capabilities. We look forward to Datang's involvement as we continue our major technology innovation and product introductions to service the burgeoning China mobile market. We expect that Zoom will continue to outpace our competition to meet the customers' demand throughout China."
About Zoom Technologies
Zoom Technologies is a holding company with subsidiaries that engage in the manufacturing, research and development, and sale of electronic and telecommunication products for 3rd generation mobile phones, wireless communication circuitry, and related software products. Zoom Technologies' subsidiary, Jiangsu Leimone, owns a majority stake of TCB Digital, which offers highly customized and high quality Electronic Manufacturing Service (EMS) for Original Equipment Manufacturer (OEM) customers as well as its own brand under the brand name of Leimone. The company's products are both exported and sold domestically. For more information about Zoom Technologies please visit Zoom's corporate website at http://www.zoomleimone.com.
Forward-Looking Statements
Certain statements in this press release may constitute "forward looking statements" that involve risks and uncertainties. These include statements about our expectations, plans, objectives, assumptions or future events, including our expansion in other 3G enabled mobile phones and the acquisition of Leimone Culture, which may require shareholder approval that cannot be assured. You should not place undue reliance on these forward-looking statements. Information concerning factors that could cause our actual results to differ materially from these forward-looking statements can be found in our periodic reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly release revisions to these forward-looking statements to reflect future events or circumstances or reflect the occurrence of unanticipated events.
...list the Corporation’s common stock on the NYSE_AMEX or on the NASDAQ exchange...
Current report filing (8-K)
http://ih.advfn.com/p.php?pid=nmona&article=43520473&symbol=NB^NWCI
Date : 07/07/2010 @ 4:17PM
Source : Edgar (US Regulatory)
Stock : (NWCI)
By written consent of the holders of a majority of its common shares as of April 21, 2010, the Company received shareholder approval to the following:
a)
the election of each of the following individuals, each a current director of the Company, to serve as a member of the Board of Directors until the next annual meeting of stockholders or until a successor is elected:
Robert N. Blair
Michael Hanson
James A. Heisch
Jess Jones, M.D.
Mark W. Kroll, Ph. D.
Patrick McGuire, M.D., Ph.D.
Branislav Vajdic, Ph.D.
Subsequently, on June 14, 2010, the Board of Directors unanimously approved increasing the Board of Directors to eight; appointing Vincent Renz, Jr., it’s newly appointed President and Chief Executive to this eighth directorship;
b)
file with the Secretary of State of the State of Delaware a Certificate of Amendment to its Amended and Restated Certificate of Incorporation increasing to 500,000,000 from 99,000,000 the authorized number of shares of common stock, par value $0.001 per share, available for issuance by the Company and providing that the Company shall be authorized to issue up to 1,000,000 shares of preferred stock par value $0.001 and to provide option and warrant holders specific rights to approve any waivers or amendments to their rights;
c)
the Corporation is authorized to file an amendment to its Amended and Restated Articles of Incorporation to effect a reverse stock split of the Corporation’s common stock at a ratio with the range of 1:2 to 1:4, as determined by the Corporation’s Board of Directors, solely in the event it is deemed by the Board of Directors to be necessary for the Corporation to list the Corporation’s common stock on the NYSE AMEX or on the NASDAQ exchange or to maintain its listing with such exchange; and ; thereafter, at the discretion of the Board of Directors, file with the Secretary of State of the State of Delaware a Certificate of Amendment to its Amended and Restated Certificate of Incorporation he Company to amend and restate its Amended and Restated Articles of Incorporation to reduce the number of shares of common stock, par value $0.001, that the Corporation is authorized to issue, to 125,000,000 shares or any number of shares between 500,000,000 and 125,000,000;
d)
approval of the 2009 Equity Compensation Plan of the Company (the “Plan”), approved by the Board of Directors on April 15, 2009, and filed with the Securities and Exchange Commission (the “SEC”) on June 16, 2009, as Exhibit 10.1 to the Company’s Registration Statement on Form S-8, and it was further approved by the majority shareholders that there shall be reserved for the Plan, 8 million shares of the Company’s common stock, plus a number of shares annually as of April 15 th of each year as shall equal ten (10%) percent of the issued and outstanding common stock, on a fully diluted basis;
e)
ratifying in their entirety the transactions and documents described in the Corporation’s current report on 8-K, filed with the SEC on July 30, 2009, as the same have been amended to date, including the amendment described in the Corporation’s current report on 8-K, filed with the SEC on December 30, 2009; and
f)
ratifying in their entirety the transactions and documents described in the Corporation’s current report on 8-K, filed with the SEC on September 18, 2009.
BRIEF-Discovery Laboratories appoints interim CEO
09.07.2010 18:46
http://www.finanznachrichten.de/nachrichten-2010-07/17373283-brief-discovery-laboratories-appoints-interim-ceo-020.htm
July 9 (Reuters) - Discovery Laboratories Inc:
* Amends non-employee executive agreement with amick; extends term of the
agreement to June 30, 2011
* Says appoints Thomas Amick as interim chief executive officer
((Bangalore Equities Newsroom; +91 80 4135 5800; within U.S. +1 646 223 8780))
COPYRIGHT
Copyright Thomson Reuters 2010. All rights reserved.
The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
© 2010 AFX News
#################################################################################################
http://biz.yahoo.com/e/100709/dsco8-k.html
9-Jul-2010
Change in Directors or Principal Officers
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On July 2, 2010, Discovery Laboratories, Inc. (the "Company") entered into an amendment (the "Amendment") to the non-employee executive agreement, dated August 13, 2009, between the Company and its director W. Thomas Amick (the "Agreement"), pursuant to which Mr. Amick assumed the responsibilities of the Company's Chief Executive Officer on an interim basis. The Amendment extends the term of the Agreement to June 30, 2011; however, the Agreement, as amended, remains subject to earlier termination at any time upon ten days' written notice to the other party.
In connection with the Amendment, the Compensation Committee of the Company's Board of Directors authorized a grant of an option to Mr. Amick to purchase 30,000 shares of the Company's common stock under the Company's 2007 Long-Term Incentive Plan. The option has an exercise price of $0.18, the closing market price of the Company's common stock on July 7, 2010, the date of grant.
The description of the remaining terms and conditions of the Agreement is incorporated by reference to the Company's current report on Form 8-K filed on September 4, 2009 and the full text of the Agreement attached as Exhibit 10.1 thereto.
Unilife Appoints Christopher Naftzger as General Counsel, Corporate Secretary and Chief Compliance Officer
Date : 07/07/2010 @ 8:45AM
Source : PR Newswire
Stock : Unilife (MM) (UNIS)
http://ih.advfn.com/p.php?pid=nmona&article=43512778&symbol=UNIS
Unilife Corporation ("Unilife" or "Company") (Nasdaq: UNIS, ASX: UNS), today announced that it has expanded its management team to include Christopher Naftzger as the Company's General Counsel, Corporate Secretary and Chief Compliance Officer. Mr. Naftzger will provide the management team and Board of Directors of Unilife with counsel on all international, legal and government matters as well as corporate finance and SEC regulation.
Prior to joining Unilife, Mr. Naftzger served on the senior management team as assistant general counsel and assistant secretary of Chesapeake Corporation, a global supplier of packaging to the pharmaceutical, healthcare and consumer industries. While at Chesapeake, Mr. Naftzger participated in all Board of Directors and Board Committee meetings as well as coordinated with the global sales team on negotiations for multi-year / multi-product supply contracts with a number of leading pharmaceutical and healthcare companies.
Mr. Naftzger has also served as the senior counsel at Koch Industries, Inc, the second largest privately held company in the U.S. with revenues of approximately $98 billion in 2008, and as a partner at Blank Rome LLP, a full service international law and government affairs firm. He holds a juris doctorate from Willamette University College of Law in Oregon, and a bachelor's degree from Hampden-Sydney College in Virginia.
Mr. Alan Shortall, Chief Executive Officer of Unilife, said, "We are pleased to add Chris to our executive team. We believe his extensive knowledge and experience as a lawyer and corporate secretary will be an asset as we continue to expand the Company, and build commercial relationships with a number of pharmaceutical customers. His appointment should also help to reduce outside legal costs in areas such as SEC compliance and contract negotiations."
About Unilife Corporation
Unilife Corporation is a U.S.-based medical device company focused on the design, development, manufacture and supply of a proprietary range of retractable syringes. Primary target customers for Unilife products include pharmaceutical manufacturers, suppliers of medical equipment to healthcare facilities and patients who self-administer prescription medication. These patent-protected syringes incorporate automatic and fully-integrated safety features which are designed to protect those at risk of needlestick injuries and unsafe injection practices. Unilife is ISO 13485 certified and has FDA-registered medical device manufacturing facilities in Pennsylvania.
This press release contains forward-looking statements. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and on information currently available to our management. Our management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in "Item 1A. Risk Factors" and elsewhere in our registration statement on Form 10 and those described from time to time in our periodic reports which we file with the Securities and Exchange Commission.
NexMed Regains Compliance with NASDAQ Listing Requirements
Date : 07/07/2010 @ 8:30AM
Source : Business Wire
Stock : NexMed, Inc. (NEXMD)
http://ih.advfn.com/p.php?pid=nmona&article=43512327&symbol=N^NEXMD
NexMed, Inc. (Nasdaq: NEXMD), a specialty CRO with a pipeline of product candidates based on the NexACT® technology, today announced that the Company received a letter, dated July 6, 2010 from The NASDAQ Hearings Panel (the “Panel”), stating that it has met the requirements of the Panel’s decision dated December 17, 2009, as modified February 1, 2010, and the applicable requirements for listing on The NASDAQ Stock Market. Accordingly, the Panel has determined to continue the listing of the Company’s securities on The NASDAQ Stock Market.
Dr. Bassam Damaj, President and Chief Executive Officer of NexMed, noted, “Overcoming the series of deficiencies we have had since October 2008 has been a major objective for management and a noteworthy accomplishment for the Company. Meeting our NASDAQ milestone is the first of many in our growth strategy for 2010 and beyond.”
About NexMed
NexMed is the largest specialty CRO based in San Diego, CA and is one of the industry's most experienced CROs for in vitro and in vivo pharmacology services and research models. The Company’s goal is to generate revenues from the growth of its Discovery Pre-clinical CRO business, while aggressively seeking to monetize its proprietary NexACT drug delivery technology through out-licensing agreements with pharmaceutical and biotechnology companies, worldwide. At the same time, NexMed is actively pursuing partnering opportunities for its NexACT-based treatments for onychomycosis, psoriasis, sexual dysfunction and cancer. For further information on NexMed and its subsidiaries, visit the following websites: http://www.nexmed.com or http://www.bio-quant.com.
##################################################################
http://ih.advfn.com/p.php?pid=squote&symbol=nexmd
Outstanding: 8,816,007
Float: 7,661,490
Cardium Regains Listing Compliance With NYSE Amex
Date : 07/07/2010 @ 9:00AM
Source : PR Newswire
http://ih.advfn.com/p.php?pid=nmona&article=43513222&symbol=CXM
Cardium Therapeutics (NYSE Amex: CXM) today reported that the Company has received a letter from the NYSE Amex LLC informing Cardium that it has now resolved matters relating to the Company's exchange listing compliance.
(Logo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO)
(Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO)
In the communication from NYSE Amex LLC, Cardium was informed that based upon a review of publicly available information, including the Company's Form 8-K filed on June 24, 2010, the Company has resolved the continued listing deficiencies referenced in the NYSE Amex LLC's letter dated December 28, 2009, as previously reported. In addition, the Exchange also indicated that as with the case for all listed issuers, the Company's continued listing eligibility will continue to be assessed on an ongoing basis and that the Company is subject to the provisions of Section 1009(h) of the NYSE Amex Company Guide, which may be accessed at www.nyse.com/regulation.
About Cardium
Cardium is focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses that have the potential to address significant unmet medical needs and definable pathways to commercialization, partnering and other economic monetizations. Cardium's investment portfolio includes the Tissue Repair Company and Cardium Biologics, medical technology companies primarily focused on the development of innovative therapeutic products for wound healing, bone repair, and cardiovascular indications. In July 2009, Cardium completed the sale of its InnerCool Therapies medical device business to Royal Philips Electronics, the first asset monetization from the Company's biomedical investment portfolio. News from Cardium is located at www.cardiumthx.com.
Forward-Looking Statements
Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that the company can continue to maintain levels of stockholders' equity in excess of the exchange's listing requirements or otherwise maintain compliance with all of the requirements of its listing exchange or that its shares can continue to be listed on national exchange, that planned product development efforts and clinical studies can be performed in an efficient and effective manner, that results observed in one study or using one type of product or procedure will be replicated in subsequent studies or in studies using newly-developed products or procedures, that regulatory approvals can be obtained in a timely manner or at all, that partnering, distribution or other commercialization efforts can be achieved, that product modifications or launches will be successful or that the resulting products will be favorably received in the marketplace, that our products or proposed products will prove to be sufficiently safe and effective, that our products or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive, that results or trends observed in one clinical study will be reproduced in subsequent studies, that third parties on whom we depend will behave as anticipated, or that necessary regulatory approvals will be obtained. Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, risks and uncertainties that are inherent in the development, testing and marketing of biologics and medical devices and the conduct of human clinical trials, including the timing, costs and outcomes of such trials, whether our efforts to launch new biologics and devices and expand our markets will be successful or completed within the time frames contemplated, our dependence upon proprietary technology, our ability to obtain necessary funding, regulatory approvals and qualifications, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition, as well as other risks described from time to time in filings we make with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
Copyright 2010 Cardium Therapeutics, Inc. All rights reserved.
For Terms of Use Privacy Policy, please visit www.cardiumthx.com.
Cardium Therapeutics™ and Generx™ are trademarks of Cardium Therapeutics, Inc.
Tissue Repair™, Gene Activated Matrix™, GAM™, Excellagen™ and Excellarate™ are trademarks of Tissue Repair Company.
SOURCE Cardium Therapeutics
Investor Presentation (June 2010)
http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9NDkyMjR8Q2hpbGRJRD0tMXxUeXBlPTM=&t=1
ZOOM - Corporate Presentation (July 2010)
PRESENTATION - July 2010
http://www.sec.gov/Archives/edgar/data/822708/000113626110000149/exh99-1.htm
http://content.edgar-online.com/edgar_conv_pdf/2010/07/01/0001136261-10-000149_EXHIBIT99-1.PDF
Semifinal (2): Germany - Spain (July 7, 2010)
Semifinal (1): Uruguay - Netherlands (July 6, 2010)
World Cup 2010 - Glorious Germany crush Argentina
Eurosport - Sat, 03 Jul 17:11:00 2010
http://eurosport.yahoo.com/03072010/58/world-cup-2010-glorious-germany-crush-argentina.html
Germany stormed into the World Cup semi-finals as they swept aside Argentina 4-0 at the Green Point Stadium in Cape Town.
Germany made a lightning start as Thomas Mueller headed home a Bastian Schweinsteiger free-kick inside three minutes and Miroslav Klose added a second-half brace either side of Arne Friedrich's first international goal.
Joachim Loew's side will now be clear favourites for a fourth World Cup title after following up their 4-1 demolition of England with an even more impressive performance against Diego Maradona's outclassed side.
Mueller scored the quickest goal of the World Cup so far after two minutes and 40 seconds to give Germany a dream start.
The Bayern Munich forward, 20, got ahead of Nicolas Otamendi to score his fourth goal of the tournament with a hopelessly static Argentina keeper Sergio Romero only able to get a palm on the ball.
Germany were in complete control in the opening quarter and should have gone two up when Mueller burst into the penalty area and squared to Klose who lofted over the bar from eight yards.
Gradually Argentina did get a foothold in the game and Manuel Neuer was called into a save at his near post to deny Gonzalo Higuain who then had an effort chalked off for offside.
But Germany were always a danger with their breaks at pace and a Lukas Podolski drive just swerved past the far post before Philipp Lahm and Mueller combined to set up Mesut Ozil but he blasted over the crossbar from 20 yards.
Mueller saw a goalbound poke deflected off Nicolas Burdisso on the stroke of half-time but Argentina had their best spell of the match after the interval.
Angel Di Maria's 20-yard effort just faded past the post, a Carlos Tevez volley smacked into the face of Per Mertesacker while Neuer got lucky when a Higuain pull back bounced off his body but only into the path of Sami Khedira.
Neuer also fumbled Higuain's close-range effort but got everything behind shots from Tevez and Di Maria before Germany ensured a trip to Durban for Wednesday's second semi-final in the space of seven second-half minutes.
Klose doubled Germany's advantage after 67 minutes as Mueller hooked the ball through to Podolski whilst on the floor and he squared to the veteran hitman who tapped home from close range with the Argentine defence wide open after Otamendi lunged in.
The third came after a sensational run from the outstanding Schweinsteiger who waltzed past two players from a short corner and pulled back to centre-half Friedrich who smuggled home from close range.
And a fourth goal a minute from time put the icing on Germany's 10th World Cup quarter-final victory in 13 attempts as a lightning break culminated in Ozil crossing to Klose who volleyed home with superb composure.
Klose was earning his 100th cap and with his double moved into joint second-place with Gerd Mueller on the all-time World Cup top scorers list.
He will get a chance to improve on his 14-goal tally in midweek although he will not be joined by Mueller whose suspension for a second yellow card in the tournament was the only sour note for the vibrant Germans.
221.2 million shares of common stock outstanding as of June 30, 2010.
http://ih.advfn.com/p.php?pid=nmona&article=43434665&symbol=N^SNSS
Sunesis Closes $28.5 Million Final Tranche of 2009 Private Placement
Date : 06/30/2010 @ 4:00PM
Source : MarketWire
Stock : Sunesis Pharmaceuticals, Inc. (SNSS)
Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today announced that, in a final closing under a securities purchase agreement entered into on March 31, 2009 with a group of accredited investors, Sunesis has sold $28.5 million of common stock at a price of $0.275 per share. In conjunction with this common stock closing, all outstanding shares of Series A preferred stock issued in the April and October 2009 closings of the private placement have been converted into common stock. Sunesis estimates that net proceeds from the closing will be approximately $26.7 million, with associated fees to the placement agents in the 2009 private placement due in the third quarter.
Giving effect to the gross proceeds from the common stock closing announced today, net proceeds of $10.3 million to date from sales through the controlled equity offering facility entered into in April 2010 and estimated second quarter expenses, Sunesis estimates that it has approximately $49.3 million of cash and cash equivalents as of June 30, 2010. Giving effect to the financings and the conversion of all outstanding shares of Series A preferred stock, Sunesis has 221.2 million shares of common stock outstanding as of June 30, 2010.
"With a strong balance sheet, Sunesis is well positioned to move forward with the initiation of our pivotal Phase 3 trial of voreloxin in acute myeloid leukemia while we continue to evaluate financial and strategic options for realizing its full clinical and commercial potential. We remain on track with our plan to start a pivotal trial this year," said Daniel Swisher, Sunesis' Chief Executive Officer. "Further, the common stock closing announced today marks the investors' exercise of their rights to invest in a final tranche of our 2009 private placement and the return of our capital structure to a single class of stock. We appreciate the strong ongoing support of the investor group."
The securities purchase agreement provided for the private placement of $43.5 million of shares, all of which have now been sold. Participants in the private placement included funds managed by Bay City Capital, New Enterprise Associates, Alta Partners, Caxton Advantage Life Sciences Fund, Merlin Nexus, Nextech Venture, OpusPoint Partners, Venrock Associates and Vision Capital Advisors and members of Sunesis' management.
About Voreloxin
Voreloxin is a first-in-class anticancer quinolone derivative, or AQD, a class of compounds that has not been used previously for the treatment of cancer. Voreloxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Voreloxin is currently being evaluated in a fully enrolled single agent Phase 2 clinical trial (known as the REVEAL-1 trial) in previously untreated elderly AML patients and in a fully enrolled Phase 2 clinical trial combining voreloxin with cytarabine for the treatment of patients with relapsed/refractory AML. A Phase 2 single agent clinical trial in platinum-resistant ovarian cancer has also completed enrollment. Sunesis plans to initiate a multinational, randomized, double-blind, placebo-controlled, pivotal Phase 3 clinical trial of voreloxin in combination with cytarabine in a relapsed/refractory AML patient population in the second half of this year.
About Acute Myeloid Leukemia
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The National Cancer Institute estimated that nearly 13,000 new cases of AML were diagnosed and approximately 9,000 deaths from AML occurred in the U.S. in 2009. Additionally, it is estimated that prevalence of AML is approximately 25,000 in the U.S. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. AML patients with relapsed or refractory disease and newly diagnosed AML patients over 60 years of age with poor prognostic risk factors typically die within one year, resulting in an acute need for new treatment options for these patients.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, voreloxin, in multiple indications to improve the lives of people with cancer. For additional information on Sunesis Pharmaceuticals, please visit http://www.sunesis.com.
This press release contains forward-looking statements, including without limitation statements related to the amount of the net proceeds from the closing of the common stock sale under the 2009 private placement, Sunesis' cash and cash equivalents as of June 30, 2010, Sunesis' evaluation of financial and strategic options for realizing voreloxin's clinical and commercial potential, Sunesis' plans to initiate a pivotal Phase 3 clinical trial of voreloxin in the second half of this year and voreloxin's mechanism of action and results that may warrant further clinical evaluation of voreloxin. Words such as "estimates," "evaluate," "positioned," "on track," "plans," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Sunesis' current expectations. Forward-looking statements involve risks and uncertainties. Sunesis' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include without limitation, risks related to Sunesis' need for additional funding to fully finance the planned voreloxin pivotal trial, the risk that Sunesis' development activities for voreloxin could be halted or significantly delayed for various reasons, the risk that Sunesis' clinical studies for voreloxin may not demonstrate safety or efficacy or lead to regulatory approval, the risk that data to date and trends may not be predictive of future data or results, the risk that Sunesis' nonclinical studies and clinical studies may not satisfy the requirements of the FDA or other regulatory agencies, risks related to the conduct of Sunesis' clinical trials, risks related to the manufacturing of voreloxin, and the risk that Sunesis' proprietary rights may not adequately protect voreloxin. These and other risk factors are discussed under "Risk Factors" and elsewhere in Sunesis' Quarterly Report on Form 10-Q for the quarter ended March 31, 2010 and other filings with the Securities and Exchange Commission. Sunesis expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
SUNESIS and the logo are trademarks of Sunesis Pharmaceuticals, Inc.
Unilife Corporation Joins the Russell 3000, Russell Microcap and Russell Global Indexes
Date : 06/28/2010 @ 8:56AM
Source : PR Newswire
Stock : Unilife (MM) (UNIS)
http://ih.advfn.com/p.php?pid=nmona&article=43391180&symbol=UNIS
Unilife Corporation ("Unilife" or "Company") (Nasdaq: UNIS, ASX: UNS) announced that it was added to the Russell 3000®, Russell Microcap® and Russell Global® indexes in the U.S. as of Friday, June 25, 2010.
The Russell 3000® Index is comprised principally of the 3,000 largest and most liquid stocks based and traded in the U.S. Russell determines membership for its equity indexes primarily by objective, market-capitalization rankings and style attributes. Membership in the Russell indexes remains in place for one year.
"Being included in the Russell indexes so soon after completing Unilife's listing on the NASDAQ Global Market is a significant validation of our redomiciliation from Australia to the U.S.," stated Alan Shortall, CEO of Unilife Corporation. "Membership in these widely followed indexes will help increase Unilife's visibility among investors in the U.S. equity market."
"Most companies that joined the Russell 3000 and associated indexes, including Unilife Corporation, experienced a significant increase in the trading volume of their common stock on U.S. exchanges on Friday, June 25. There were almost seven million Unilife shares traded on Friday, which is the equivalent of 41.7 million CDIs with a value of approximately US$50 million. We expect much of the increase in Unilife trading volume on Friday represented the inflow of U.S. investors that track the Russell indexes." said Mr. Shortall.
Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for both passive and active investment strategies. An industry-leading US$3.9 trillion in assets currently are benchmarked to the Russell indexes. These investment tools originated from Russell's multi-manager investment business in the early 1980s when the company saw the need for a more objective, market-driven set of benchmarks in order to evaluate outside investment managers.
Total returns data for the Russell 3000® and other Russell Indexes is available at http://www.russell.com/Indexes/performance/default.asp.
About Russell
Russell Investments provides strategic advice, world-class implementation, state-of-the-art performance benchmarks and a range of institutional-quality investment products. Russell has $179 billion in assets under management as of March 31, 2010, and serves individual, institutional and advisor clients in more than 40 countries. Founded in 1936, Russell is a subsidiary of The Northwestern Mutual Life Insurance Company.
About Unilife Corporation
Unilife Corporation is a U.S.-based medical device company focused on the design, development, manufacture and supply of a proprietary range of retractable syringes. Primary target customers for Unilife products include pharmaceutical manufacturers, suppliers of medical equipment to healthcare facilities and patients who self-administer prescription medication. These patent-protected syringes incorporate automatic and fully-integrated safety features which are designed to protect those at risk of needlestick injuries and unsafe injection practices. Unilife is ISO 13485 certified and has FDA-registered medical device manufacturing facilities in Pennsylvania.
This press release contains forward-looking statements. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and on information currently available to our management. Our management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in "Item 1A. Risk Factors" and elsewhere in our registration statement on Form 10 and those described from time to time in our periodic reports which we file with the Securities and Exchange Commission.
Zoom Technologies Unveils LEIMONE E66 3G Phone for China Telecom
Date : 06/28/2010 @ 8:00AM
Source : MarketWire
Stock : Zoom Technologies (ZOOM)
http://ih.advfn.com/p.php?pid=nmona&article=43389948
Zoom Technologies, Inc. (NASDAQ: ZOOM), a leading China-based manufacturer of mobile phones and other mobile electronic products, today unveiled the LEIMONE E66, our newest model designed specifically for China Telecom's 3G network. Following the successful release of our E63 model two months ago, the elegantly designed E66 supports CDMA2000/GSM dual-mode with two card slots, UIM & SIM -- allowing access to both networks simultaneously. The E66 sports a 2.8-inch high resolution 16:9 aspect ratio screen, an exterior LED clock and will be offered in several pastel colors. Similar to the popular E63 model, it is fully compatible with China Telecom's 3G applications, has web browsing capabilities, an upgraded 3.2M pixels primary camera and a secondary camera for video conferencing. In addition, the E66 contains GPS navigation and an application for mobile bill paying. The E66 is expected to be available in August.
Mr. Leo Gu, Chief Executive Officer of Zoom Technologies, said, "Zoom continues its record of innovation with the debut of the E66 phone. The design and features of our newest model demonstrates Zoom's thorough understanding of China's mobile phone market. The elegant design and pastel colors will have appeal to the country's growing professional female customer base. This offering further strengthens our ongoing relationship with China Telecom."
For more information on the LEIMONE E66 and other LEIMONE phones, please visit Zoom Technologies website at www.zoomleimone.com.
About Zoom Technologies
Zoom Technologies is a holding company with subsidiaries that engage in the manufacturing, research and development, and sale of electronic and telecommunication products for 3rd generation mobile phones, wireless communication circuitry, and related software products. Zoom Technologies' subsidiary, Jiangsu Leimone, owns a majority stake of TCB Digital, which offers highly customized and high quality Electronic Manufacturing Service (EMS) for Original Equipment Manufacturer (OEM) customers as well as its own brand under the brand name of Leimone. The company's products are both exported and sold domestically. For more information about Zoom Technologies please visit Zoom's corporate website at http://www.zoomleimone.com.
Forward-Looking Statements
Certain statements in this press release may constitute "forward looking statements" that involve risks and uncertainties. These include statements about our expectations, plans, objectives, assumptions or future events, including our expansion in other 3G enabled mobile phones and the acquisition of Leimone Culture, which may require shareholder approval that cannot be assured. You should not place undue reliance on these forward-looking statements. Information concerning factors that could cause our actual results to differ materially from these forward-looking statements can be found in our periodic reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly release revisions to these forward-looking statements to reflect future events or circumstances or reflect the occurrence of unanticipated events.
Image Available: http://www2.marketwire.com/mw/frame_mw?attachid=1293986
Image Available: http://www2.marketwire.com/mw/frame_mw?attachid=1293984
Contacts:
Chris Danne/Cynthia Hiponia
The Blueshirt Group
+1 415-217-5865 / 4966