|CytRx moves into Phase II trial for leukemia drug. Peregrine Pharma reports positive data from advanced breast cancer study|
|By BioMedReports.com Staff|
|Friday, 28 May 2010 17:18|
Below is a list of the companies that made news in the healthcare sector on Friday, May 28, 2010.
CytRx Corporation (NASDAQ: CYTR), announced initiation of a Phase 2 proof-of-concept clinical trial to evaluate the preliminary efficacy and safety of its oncology drug candidate bafetinib in patients with high-risk B-cell chronic lymphocytic leukemia (B-CLL).
"This is the first of six Phase 2 proof-of-concept clinical trials we plan to initiate this year with our promising oncology candidates bafetinib and INNO-206 and, importantly, marks a major milestone in our evolution as an oncology company," said CytRx President and CEO Steven A. Kriegsman. "Our strategy is to conduct small proof-of-concept studies and, based on the success of these trials, further determine efficacy by quickly moving into larger comparative trials either using our internal resources or with partners. This strategy reflects our goals of rapidly advancing our oncology pipeline toward commercialization and enhancing shareholder value."
Shares of CytRx rose 7 cents or 7.29% to $1.03.
Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) announced new median progression-free survival (PFS) data of 7.4 months from a Phase II trial evaluating bavituximab in combination with docetaxel in refractory patients with advanced breast cancer. Best overall response rate from this trial was 61% (28 of 46 patients) with 11% (5 of 46) of the patients achieving a clinical complete response. These results compare favorably to data from a separate published study showing an objective response rate of 41% with no complete responses in a similar patient population receiving docetaxel alone. These Phase II data will be highlighted in a poster presentation on June 5, 2010 at the ASCO Annual Meeting.
"With promising breast cancer data in both front-line and refractory patients, as well as in different therapeutic combinations and indications, Peregrine's novel monoclonal antibodies offer broad-spectrum potential for the treatment of breast cancer and other solid tumors," commented Alison Stopeck, M.D., Associate Professor of Medicine, director of clinical breast cancer program at the Arizona Cancer Center. "New cancer therapies that reactivate and direct the patient's immune system are generating growing interest among cancer researchers and clinicians. Peregrine's antibodies are a unique approach to treating cancer, targeting the highly specific immunosuppressive molecule called phosphatidylserine to reactivate the immune system response."
Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board:ADLS.ob), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced the expansion of its collaboration with the U.S. Government to include the evaluation of Restanza's activity against sexually transmitted infections (STI's), such as gonorrhea. Under the expanded agreement, Restanza's in vitro activity against Neisseria gonorrhoeae and other key STI's will be assessed, with the potential to advance Restanza into clinical development in government-sponsored clinical trials.
Amgen Inc. (Nasdaq:AMGN) announced that the European Commission (EC) has granted marketing authorization for Prolia for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, and for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. Prolia has been approved in all 27 European Union member states plus Norway, Iceland and Liechtenstein. The European approval of Prolia marks the first approval of the product worldwide.
"The European approval of Prolia is a significant medical advance for patients with bone loss conditions," said Will Dere, senior vice president and international chief medical officer at Amgen. "In particular, we believe that Prolia will offer patients with postmenopausal osteoporosis at increased risk for fracture an important alternative to current treatments. Prolia reduces the risk of fracture through a convenient injection given every six months. Amgen is proud to make this new treatment available to physicians and their patients."
Bioheart, Inc., (OTC Bulletin Board:BHRT.ob) announced today plans for establishing two Centers of Excellence in the Middle East to provide its cell therapy procedures to patients suffering from congestive heart failure (CHF) and peripheral arterial disease (PAD).
BIOLASE Technology, Inc. (NASDAQ:BLTI), the world's leading dental laser company, announced today that it has entered into a $5 million secured debt facility with MidCap Financial, LLC and Silicon Valley Bank. BIOLASE received a first tranche of $3 million at closing, with a second tranche of $2 million, available upon completion of certain conditions. The financing will be used for ongoing working capital requirements.
Misonix, Inc. (Nasdaq:MSON), a developer of minimally invasive ultrasonic medical device technology, which is used in Europe for the ablation of tumors and worldwide for acute health conditions, announced the sale to USHIFU, LLC of all of the rights to the High Intensity Focused Ultrasound technology previously obtained from Focus Surgery, Inc., a wholly owned subsidiary of USHIFU, together with other HIFU related assets. In consideration for the sale Misonix will receive up to approximately $5.8 million, paid out of an earn-out of 7% of gross revenues received by USHIFU related to the businesses being sold, up to the time we have received the first $3 million, and thereafter 5% of gross revenues up to the $5.8 million. Misonix will also be paid for its present inventory of new SB500 machines, inventory associated with manufacturing the SB500® and will be reimbursed for certain monies expended in connection with the HIFU Registry.
VaxGen, Inc. (OTC Bulletin Board:VXGN.ob), a biopharmaceutical company, and diaDexus, Inc., a privately held diagnostics company focused on the development and commercialization of patent-protected in vitro diagnostic products addressing unmet needs in cardiovascular disease, announced today that they have entered into a definitive agreement under which VaxGen will acquire diaDexus in a stock-for-stock merger.
VIVUS, Inc. (Nasdaq:VVUS) moved higher Friday after the company announced that phase 3 data on avanafil, a next generation oral phosphodiesterase type 5 (PDE5) inhibitor therapy being investigated for the treatment of erectile dysfunction (ED), will be presented next Tuesday, June 1st, at the American Urological Association (AUA) 2010 Annual Meeting in San Francisco, California.
Advaxis, Inc., (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Lm) biotechnology company, has dosed the first patient in its US Food and Drug Administration (FDA)-approved, phase II clinical trial in cervical intraepithelial neoplasia (CIN), commonly known as cervical dysplasia.
Amarillo Biosciences, Inc. (ABI) (OTCBB: AMAR) today announced that Maxisal, its dietary supplement to enhance salivary function, promote oral comfort and help relive dry mouth, has been launched in Germany.
American Medical Systems (AMS) (Nasdaq: AMMD), a leading provider of world-class devices and therapies for both male and female pelvic health, today announced the launch and immediate availability of its new GreenLight XPS (Xcelerated Performance System) for laser treatment of benign prostatic hyperplasia (BPH) or enlarged prostate.
Celgene Corporation (NASDAQ: CELG) today announced its presentations at three upcoming investor conferences will be webcast live and will be available in the investor relations section of the company's Web site.
EpiCept Corporation (Nasdaq: EPCT) today announced that its annual shareholder meeting will be accessible to investors via webcast.
Huiheng Medical, Inc. (OTC Bulletin Board: HHGM), a leading provider of advanced radiation therapy solutions for cancer care in China, will host a conference call discussing its financial results for the period ended March 31, 2010 on Wednesday, June 2nd at 9:00 a.m. EDT.
Inhibitex, Inc. (NASDAQ:INHX), a biopharmaceutical company focused on developing products to treat and prevent serious infectious diseases, announced that Russell H. Plumb, President and Chief Executive Officer, is scheduled to present an overview of the company and its pipeline of differentiated antiviral compounds.
Life Technologies Corporation (NASDAQ:LIFE), a provider of innovative life science solutions, announced today that it has concluded its tender offer and acquire a majority stake in Geneart AG, the global leader of the synthetic gene market segment.
Santarus, Inc. (NASDAQ:SNTS), a specialty biopharmaceutical company, today announced that Gerald T. Proehl, president and chief executive officer, will make a presentation at the Jefferies 2010 Global Life Sciences Conference on Tuesday, June 8, 2010, at 11:00 a.m. Eastern time (8:00 a.m. Pacific time) at the Grand Hyatt in New York City.
Wright Medical Group, Inc. (NASDAQ: WMGI), a global orthopaedic medical device company, announced today that Raymond C. Kolls has joined the Company's executive staff as Sr. Vice President, General Counsel and Secretary.
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.