|ImmunoGen soars on positive breast cancer study results. After the bell: Cutera moves higher on 510(k) clearence|
|By BioMedReports.com Staff|
|Thursday, 07 April 2011 18:40|
After the market closed Thursday, Cutera, Inc. (Nasdaq:CUTR), a leading worldwide provider of laser and light-based aesthetic systems for practitioners worldwide, today announced U.S. Food and Drug Administration 510(k) clearance for its GenesisPlus.
Known medically as onychomycosis, nail fungus often causes the toenails to become discolored, thickened and separated from the nail bed. Approximately half of the population will have at least one infected toenail during the course of their lives. Current treatment options include prescription topicals and oral drugs, both with limited success rates. Some patients are not candidates for oral medications, due to concerns of liver damage and other treatment limitations.
"The GenesisPlus laser is a great innovation in the treatment of fungal nails and it has exceeded my expectations for safety and efficacy," said David Weiss, Doctor of Podiatric Medicine in private practice in Hammonton, NJ. "The options I've had in the past were limited because they didn't work very well and patients were concerned about side effects."
After the bell, shares of Cutera were up 51 cents or 6% to $9.11.
Shares of ImmunoGen, Inc (Nasdaq:IMGN), made a strong upside move today after the company announced that Roche disclosed positive top-line results from the first randomized trial assessing trastuzumab emtansine (T-DM1, previously known as trastuzumab-DM1) in HER2-positive metastatic breast cancer (MBC). T-DM1 consists of ImmunoGen’s DM1 cancer cell-killing agent attached using the Company’s linker to the HER2-targeting antibody, trastuzumab, developed by Genentech, a member of the Roche Group.
The top-line results disclosed by Roche in a press release today were that patients treated with T-DM1 had a significant improvement in progression-free survival compared with patients treated with Herceptin (trastuzumab) plus chemotherapy (docetaxel) in the Phase II trial comparing these agents for first-line treatment for HER2-positive MBC.
Shares of ImmunoGen soared $2.50 or 27% to $11.80
CEL-SCI Corporation (NYSE AMEX: CVM) announced today that it has received approval to begin enrollment of patients in its Phase III clinical trial of Multikine in India from the Directorate General of Health Services Office of Drug Controller General (India) – the Indian equivalent of the FDA. India is an important country for this nine country clinical trial because about 15 of the 48 clinical centers for this global trial will be located in India and because India has the greatest number of head and neck cancer cases in the world. It is expected that patient enrollment in India will be about 4-6 times faster than would be possible in US clinical centers.
NewCardio, Inc., (OTC BB:NWCI.ob) announced today that the Company has been invited by the American Diabetes Association (ADA) to present the results of a key study showing that NewCardio's urgent care solution, my3KG, had substantially greater accuracy than expert cardiologists' interpretation of standard 12-lead ECG (12L ECG) in diagnosing Acute Myocardial Infarction (AMI) in diabetic patients. The presentation will be made at the 71st Annual ADA Scientific Sessions to be held in San Diego, CA, June 24-28, 2011.
Altitude Organic Corporation (PINKSHEETS:AMNG) , a national publicly-traded medical marijuana company, announced today that it has launched its cutting-edge mobile application for smart phone users designed to access the whereabouts and pricing for various strains of medical cannabis available at Altitude Organic's stores.