|EU Orphan Drug designation granted to Celsion. Geron data boosts stem cell stocks. Micromet drops, Synta higher on stock sales|
|By BioMedReports.com Staff|
|Thursday, 11 November 2010 19:43|
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 11, 2010.
Shares of Celsion Corporation (Nasdaq:CLSN), surged higher today after the company announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has issued a positive opinion on the application for Orphan Drug Designation for ThermoDox®, a proprietary heat-activated liposomal encapsulation of doxorubicin, for the treatment of hepatocellular carcinoma (HCC), commonly referred to as primary liver cancer. A positive opinion by the COMP immediately precedes official designation of ThermoDox® as an orphan drug by the EMA. ThermoDox® is currently being evaluated under a Special Protocol Assessment with the FDA in a 600 patient pivotal Phase III trial (the HEAT study) in patients with non-resectable primary liver cancer at 76 clinical sites in 11 different countries. ThermoDox® has previously received Orphan Drug designation by the U.S. Food and Drug Administration (FDA). In addition, the HEAT study has been designated as a Fast Track Development Program by the FDA.
Shares of Celsion hit an intra-day high of $3.40 cents before pulling back and settling at $3.06, up 16 cents or 5.52%.
Stem cell stocks got a boost today after Geron Corporation (Nasdaq:GERN) today announced the publication of preclinical data demonstrating that the company’s telomerase inhibitor drug, imetelstat (GRN163L), currently in Phase 2 clinical trials, targets cancer stem cells from multiple myeloma, pancreatic and breast cancers.
Cancer stem cells, found in many types of cancer, are rare populations of malignant cells with the capacity for endless self-renewal. They are believed to be responsible for tumor growth, recurrence and metastasis. Their resistance to chemotherapy and conventional anti-cancer agents make them important targets for novel therapies.
"These data are significant because they demonstrate that the cancer stem cell population can be targeted by inhibiting telomerase with imetelstat, and that this is associated with a survival benefit in animal models," said Stephen M. Kelsey, M.D., Geron’s executive vice president and chief medical officer, oncology. "Our Phase 2 clinical program is testing imetelstat in lung cancer, chronic leukemias, breast cancer and multiple myeloma, all malignancies in which cancer stem cells are believed to play an important role in relapse after standard therapy."
On heavy volume, shares of Geron rose 28 cents to $6.08. Earlier in the day shares hit an intra-day high of $6.23.
Shares of Micromet, Inc. (NASDAQ:MITI) fell today after the company announced a public offering of 9,900,000 shares of its common stock at a public offering price of $7.30 per share. The Company has granted the underwriter a 30-day option to purchase an additional 1,485,000 shares of common stock from the Company to cover over-allotments, if any. The closing of the offering is expected to take place on or about November 16, 2010, subject to the satisfaction of customary closing conditions. Shares dropped $1.00 or 12.5% to $7.00.
Synta Pharmaceuticals Corp. (NASDAQ:SNTA) moved higher today after the company announced the sale of 1,440,923 shares of its common stock at a price of $3.47 per share to Mr. Bruce Kovner, a member of the Board of Directors of Synta. The company will realize gross proceeds of approximately $5 million. The shares were offered directly to Mr. Kovner without a placement agent, underwriter, broker or dealer. Shares of Synta jumped 33 cents, nearly 10% to close the day at $3.67.
Also Thursday:PharmAthene, Inc. (NYSE Amex:PIP), a biodefense company developing medical countermeasures against biological and chemical threats, today reported financial and operational results for the third quarter and nine months ended September 30, 2010.
Proteonomix, Inc. (OTCBB: PROT) announced today that the joint venture investors who had contracted with Proteonomix to fund and assist in establishing operations in the United Arab Emirates through the Company's subsidiary, XGen Medical LLC ("XGen") are in default.
Radient Pharmaceuticals Corporation (RPC) (NYSE Amex:RPC) announced today its Annual Meeting of Shareholders will be held at 10:00 a.m. PST on Friday, December 3, 2010 at the Company's corporate offices located at 2492 Walnut Ave., Suite 100 in Tustin, California.
Syneron Medical Ltd. (NASDAQ: ELOS), the leading global aesthetic device company, today announced third quarter 2010 financial results for the three month period ended September 30, 2010.
TomoTherapy Incorporated (NASDAQ: TOMO), maker of advanced radiation therapy solutions for the treatment of cancer and other diseases, today announced that President and CEO Fred Robertson will present at Lazard Capital Markets Healthcare Conference 2010 on Tuesday, November 16, 2010 at 2:40 p.m. EST.
UV Flu Technologies, Inc. (OTCBB:UVFT) is pleased to announce that the Company has received favorable preliminary test results from an independent, FDA and EPA certified test facility that demonstrated the ViraTech UV-400 air purifier to be effective in the inactivation of a typical virus surrogate utilized as part of the test protocol.
Wound Management Technologies, Inc., (OTC Bulletin Board:WNDM) a leader in advanced wound care solutions, announced today that its President, Deborah Jenkins Hutchinson, will present an overview of its widely-acclaimed wound care product, CellerateRX®, recent strategic developments, and its product pipeline at the LifeTech Capital Miami Medical Investors Conference to be held at the JW Marriott Marquis Miami on November 12, 2010.
YM BioSciences Inc. (NYSE Amex: YMI, TSX: YM), a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development, today reported operational and financial results for the first quarter of fiscal 2011, ended September 30, 2010, a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, announced that it will be presenting a poster today at the 10th Annual Diabetes Technology Meeting, entitled, "Preclinical Studies with Cobalamin™ Nanoparticles for Oral Drug Delivery of Insulin."
Access Plans, Inc. (OTCBB: APNC) which designs, markets and administers consumer membership and healthcare savings membership plans, and which is a leading marketer of individual major medical insurance products, today announced that it intends to explore a broad range of strategic alternatives to enhance shareholder value, including, but not limited to, entering into a "going private" transaction, raising or borrowing money for future acquisitions, or one or more other transactions.
Ardea Biosciences, Inc. (Nasdaq:RDEA) today announced that data from preclinical and clinical trials of BAY 86-9766 (formerly known as RDEA119) will be presented at the 22nd European Organisation for Research and Treatment of Cancer (EORTC) – National Cancer Institute (NCI) – American Association for Cancer Research (AACR) symposium on "Molecular Targets and Cancer Therapeutics" in Berlin, Germany.
AtheroNova Inc. (OTCBB: AHRO) a biotech company focused on the research and development of compounds to regress atherosclerotic plaque, announced that the Company has signed a research agreement for their second round of preclinical studies to be conducted at The David Geffen School of Medicine at UCLA.
Bionovo, Inc. (Nasdaq:BNVI), a pharmaceutical company focused on the discovery and development of safe and effective treatments for women's health and cancer, today announced third quarter highlights and financial results for the three months ended September 30, 2010.
Cadence Pharmaceuticals, Inc. (Nasdaq:CADX) today announced that it has priced an underwritten public offering of 11,500,000 shares of its common stock at a price to the public of $8.00 per share.
China-Biotics, Inc. (Nasdaq:CHBT) the leading developer, manufacturer and distributor of probiotics products in China, today announced the appointment of Dr. Hui S. Chang as Chief Operating Officer, effective immediately.
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, announced today at its Annual Awards Celebration that The Edwards Lifesciences Fund at the Vanguard Charitable Endowment Program plans to grant $4.6 million in 2010 to more than 150 non-profit organizations.
eHealthInsurance (NASDAQ: EHT), the leading online source of health insurance for individuals, families, and small businesses, released ten tips to help consumers navigate their health insurance options during open enrollment season.
GreenGold Ray Energies (PINKSHEETS:GRYE) announced today that due to the increase target by the European Union of 10% of fuel sold at the pump be bio-diesel by 2020, the company will expedite its land acquisition.
Hiru Corporation (PINK SHEETS:HIRU) subsidiary Shuangshi AHP Co.'s new production line and workshop are in their final stages. The new equipment is being put in place.
Jazz Pharmaceuticals, Inc. (Nasdaq:JAZZ) announced today that Bruce Cozadd, the company's chairman and chief executive officer, will present at the Lazard Capital Markets Healthcare Conference in New York on Wednesday, November 17, 2010 at 9:00 a.m. Eastern Time.
Kendle (Nasdaq:KNDL), a leading, global full-service clinical research organization, today announced the Company will participate in the upcoming Lazard Capital Markets 7th Annual Healthcare Conference on Nov. 16, 2010 at the St. Regis New York in New York City.
NuVasive, Inc. (NASDAQ: NUVA), a medical device company focused on developing products for minimally disruptive surgical treatments for the spine, announced today that Patrick F. Williams, Vice President of Finance and Investor Relations, is scheduled to present at the Maxim Group Growth Conference at The Grand Hyatt New York Hotel in New York, NY, on Thursday, November 18, 2010, at 10:00 a.m. ET.