QLT Receives Fast Track Designations For QLT091001. Bioheart Announces US FDA Clinical Program Using Adipose Cells. Print E-mail
By Staff and Wire Reports   
Wednesday, 14 September 2011 18:25
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 14, 2011.

QLT Inc. (NASDAQ:QLTI) announced the Company's oral synthetic retinoid for retinal diseases, QLT091001, has been granted two Fast Track designations by the FDA for the treatment of Leber Congenital Amaurosis (LCA) due to inherited mutations in LRAT and RPE65 genes and for the treatment of autosomal recessive Retinitis Pigmentosa (RP) due to inherited mutations in LRAT and RPE65 genes.

The FDA's Fast Track is a process designed to facilitate the development and expedite the review of drugs that are intended for the treatment of serious diseases and fill an unmet medical need.

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Bioheart Inc (OTC:BHRTE) shares were rising after they announced they will begin a US clinical program called the ANGEL trial utilizing adipose derived cells or LipiCell for congestive heart failure patients.

Using the clinical data from a Phase I/II trial in Mexico and preclinical studies, Bioheart will apply to the FDA to begin a Phase I study in the US. In collaboration with the Regenerative Medicine Institute of Tijuana, Mexico, six congestive heart failure patients have been successfully treated in a Phase I/II trial at Hospital Angeles Tijuana.

The therapy involves the use of stem cells derived from the patient's own fat (adipose tissue) obtained using liposuction. These patients have demonstrated on average, an absolute improvement of 13 percentage points in ejection fraction and an increase of 100 meters in their 6 minute walk distance.

 
Also Wednesday:


Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
(the "Company") earlier today, presented positive final Phase 2 efficacy and safety data for its targeted cytotoxic luteinizing hormone releasing hormone (LHRH) analog, AEZS-108, in advanced endometrial cancer.

Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that Dr. Leonard Bell, Chief Executive Officer of Alexion Pharmaceuticals, will present at the UBS Global Life Sciences Conference in New York City at 2:30 p.m. Eastern on Wednesday, September 21, 2011.

Astex Pharmaceuticals, Inc. (NASDAQ:ASTX), a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, today announced that James S.J. Manuso, Ph.D., chairman and chief executive officer, and Mohammad Azab, M.D., chief medical officer, will present at the UBS Global Life Sciences Conference on Wednesday, September 21st in New York.

Callidus Software Inc. (NASDAQ: CALD), the leader in Sales Performance Management (SPM), announced today that Pfizer Inc, the world's largest research-based biopharmaceutical company, has selected the iCentera Sales Enablement SaaS platform to drive the effectiveness of its sales team in the U.S., including internal sales, contract sales, and channel partners.

Delcath Systems, Inc. (NASDAQ: DCTH) today announced that the Company sponsored an industry symposium at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) in Munich, Germany—the largest international forum for minimally invasive image-guided therapy, with more than 5,600 interventional radiologists in attendance.

Impax Laboratories, Inc.(NASDAQ: IPXL) today announced that the Company will present at the UBS Global Life Sciences Conference on Tuesday, September 20, at 7:30 a.m. ET.

Inovio Pharmaceuticals, Inc. (NYSE Amex: INO), a leader in the development of synthetic immunogens against cancers and infectious diseases, announced today that it has achieved best-in-class immune responses in a Phase I clinical study of PENNVAX™-B, its product for the prevention of the HIV sub-type prevalent in the US and Europe.

InterMune, Inc. (Nasdaq: ITMN) today announced that it has agreed to sell an aggregate of 4,000,000 shares of its common stock at a price to the public of $24.00 per share and $135.0 million aggregate principal amount of its 2.50% convertible senior notes due 2018 in concurrent underwritten public offerings.

Main Street Capital Corporation (NYSE: MAIN) ("Main Street") announced today that it has completed a new lower middle market portfolio investment totaling approximately $6.8 million in invested capital.

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Alex Kelly, Merck's senior vice president of investor relations, is scheduled to present at the Bank of America Merrill Lynch Global Healthcare Conference in London on Sept. 15 at 3:10 a.m. EDT / 8:10 a.m. GMT.

Pall Corporation (NYSE:PLL) today reported financial results for the fourth quarter and fiscal year ended July 31, 2011.

Radient Pharmaceuticals Corporation (OTCQX: RXPC) (PINKSHEETS: RXPC), a developer and marketer of In Vitro Diagnostic (IVD) cancer tests, today announced it has filed for patent protection for its proprietary Onko-Sure® cancer test in Australia and New Zealand.

Tengion, Inc. (Nasdaq:TNGN), a leader in regenerative medicine, today announced that Steven Nichtberger, M.D., President and Chief Executive Officer of Tengion, will present at the upcoming UBS Global Life Sciences Conference on Monday, September 20, 2010, at 8:30am EDT.

Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT)
received notice today from the U.S. Food and Drug Administration (FDA) that it generally agrees with Transcept proposals to address concerns raised by the FDA in its July 2011Intermezzo® Complete Response Letter.  

Zalicus Inc. (NASDAQ: ZLCS) a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases today announced that Mark H.N. Corrigan, MD, President and CEO is scheduled to present at the UBS Global Life Sciences Conference at 2:30 p.m. ET on Tuesday, September 20, 2011, at the Grand Hyatt, New York.



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