ImmunoGen soars on positive breast cancer study results. After the bell: Cutera moves higher on 510(k) clearence Print E-mail
By BioMedReports.com Staff   
Thursday, 07 April 2011 18:40
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 07, 2011.


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.

Also Thursday:

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.


Applied DNA Sciences, Inc. (OTCBB: APDN), a provider of DNA-based anti-counterfeiting technology and product authentication solutions is pleased to announce the expansion of its forensic scientific group, with the addition of Breanna Mead.

BAETA Corp. (OTCBB: BAEA), a New Jersey corporation and provider of technology-enabled health improvement products, announces that it has received clearance on April 4, 2011 from the Depository Trust & Clearing Corporation (DTCC), allowing for efficient clearing and settlement of transactions involving sales of BAETA Corp. common stock.

BIOLASE Technology, Inc. (NASDAQ: BLTI), the World's leading dental laser manufacturer and distributor, announced today plans to immediately expand BIOLASE Europe, GmbH to now include a direct sales force, along with service and support operations, for the German market.

CONMED Corporation (NASDAQ: CNMD) announced today that it expects to report first quarter 2011 financial results before the market opens on Thursday, April 28, 2011, and will also hold a conference call live over the Internet at 10:00 a.m. Eastern Time that same day.

InVivo Therapeutics (OTCBB: NVIV), a company focused on the development of groundbreaking technologies for the treatment of spinal cord injuries (SCI), today announced that a poster highlighting data from a laboratory investigation of the company's injectable hydrogel technology for local, controlled-release drug delivery, is being presented at the 79th Annual Meeting of the American Association of Neurological Surgeons (AANS), which is being held April 9-13 in Denver, Colorado.

Lakeland Industries, Inc. (NASDAQ: LAKE) today announced financial results for its fourth quarter and full fiscal year 2011 ended January 31, 2011.

Lpath, Inc. (OTCBB: LPTN), the industry leader in lipidomics-based therapeutics, has initiated enrollment in its PEDigree clinical trial of iSONEP™, the company's ocular drug candidate with which it has partnered with Pfizer (NYSE: PFE).

Marina Biotech, Inc., (NASDAQ: MRNA), a leading RNAi-based drug discovery and development company, today announced the initiation of patient dosing in the Dose Escalation Phase of its START-FAP (Safety and Tolerability of An RNAi Therapeutic in Familial Adenomatous Polyposis) clinical trial with CEQ508.Marina Biotech's Phase 1b/2a trial is an open-label, escalating-dose study of single daily doses of CEQ508 and will be conducted as a single center study in Boston, Massachusetts.

PROTEONOMIX, INC. (OTCBB: PROT) , a biotechnology company focused on developing therapeutics based upon the use of human cells and their derivatives, announced today that it has filed a provisional patent application in anticipation of commencement of its initial clinical trial of a drug combination thought to extend life expectancy for a class of terminally ill patients awaiting liver transplants.

SOHM, Inc. (PINKSHEETS: SHMN), a generic pharmaceutical manufacturer that produces and markets generic drugs covering all major treatment categories, is pleased to announce that the Company has signed a Letter Of Intent to acquire a high-growth dermatology company based in India.

 




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