Geron gets FDA go ahead to resume stem cell trial, shares soar Print E-mail
By BioMedReports.com Staff   
Friday, 30 July 2010 18:42

Geron Corporation (Nasdaq:GERN) announced today that the U.S. Food and Drug Administration has notified the company that the clinical hold placed on Geron’s Investigational New Drug application has been lifted and the company’s Phase I clinical trial of GRNOPC1 in patients with acute spinal cord injury may proceed.


The FDA notification enables Geron to move forward with the world’s first clinical trial of a human embryonic stem cell (hESC)-based therapy in man. The Phase I multi-center trial is designed to establish the safety of GRNOPC1 in patients with "complete" American Spinal Injury Association (ASIA) Impairment Scale grade A subacute thoracic spinal cord injuries.

"We are pleased with the FDA’s decision to allow our planned clinical trial of GRNOPC1 in spinal cord injury to proceed," said Thomas B. Okarma, Ph.D., M.D., Geron’s president and CEO. "Our goals for the application of GRNOPC1 in subacute spinal cord injury are unchanged – to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient’s injured spinal cord. Additionally, we are now formally exploring the utility of GRNOPC1 in other degenerative CNS disorders including Alzheimer’s, multiple sclerosis and Canavan disease."

The clinical hold was placed following results from a single preclinical animal study in which Geron observed a higher frequency of small cysts within the injury site in the spinal cord of animals injected with GRNOPC1 than had previously been noted in numerous foregoing studies. In response to those results, Geron developed new markers and assays as additional release specifications for GRNOPC1. The company completed an additional confirmatory preclinical animal study to test the new markers and assays, and subsequently submitted a request to the FDA for the clinical hold to be lifted.

Shares of Geron gained 17.29% or 83 cents to $5.63.

Charles River Laboratories International, Inc. (NYSE: CRL), a leading global provider of research models and associated services and of preclinical drug development services, today announced that it has mutually agreed with WuXi PharmaTech (Cayman) Inc. (NYSE: WX) to terminate their previously announced acquisition agreement. The Company also announced that its Board of Directors has authorized a new $500 million stock repurchase program.

Lpath, Inc. (OTC.BB:LPTN) was awarded a $3.0 million grant by the National Eye Institute's BRDG-SPAN Program to support Phase II clinical development of Lpath's iSONE in treating exudative (or wet) AMD and possibly other ocular disorders.

Volcano Corporation (Nasdaq:VOLC), a leading developer and manufacturer of precision intravascular therapy guidance tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, said today that revenues in the second quarter of 2010 increased 36 percent versus revenues in the second quarter of 2009.

Also Friday:

Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated, global biotechnology company, and Specialised Therapeutics Ltd. today announced that MEDSAFE, the New Zealand Medicines and Medical Devices Safety Authority, has approved for marketing ABRAXANE (nanoparticle albumin-bound paclitaxel) for the treatment of metastatic breast cancer after failure of anthracycline therapy.

Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) today announced its financial results for the second quarter ended June 30, 2010.

Arcadia Resources, Inc. (NYSE Amex: KAD), a leading provider of innovative consumer health care services under the Arcadia HealthCare(SM) brand, will issue its fiscal first quarter 2011 results on Monday, August 9, 2010.

ArQule, Inc. (Nasdaq: ARQL) today announced that the Company will present at the BMO Capital Markets 10th Annual Focus on Healthcare Conference on August 5, 2010 at 9:30 a.m.

AVI BioPharma, Inc. (NASDAQ: AVII) a developer of RNA-based therapeutics, announced today that the company is scheduled to present at the BMO Capital Markets 10th Annual Focus on Healthcare Conference on Thursday, August 5, 2010, at 8:30 a.m. Eastern Time in New York City.

Axia Group Inc. (PINK SHEETS:AGIJ) is pleased to announce the purchase of new subsidiary Collagenna Skin Care Products from Hard to Treat Diseases, Inc. (HTDS).

Biodel Inc. (Nasdaq: BIOD) will issue its third quarter fiscal year 2010 financial results on August 5, 2010.

BioSpecifics Technologies Corp. (Nasdaq: BSTC), a biopharmaceutical company developing first in class collagenase-based products, announced today that it will host a conference call and live audio webcast at 8:30am EDT on August 6, 2010 to report its second quarter 2010 financial results and corporate highlights.

BioScrip, Inc. (Nasdaq: BIOS) announced 2010 second quarter revenue of $412.0 million, operating income of $13.5 million and net income of $3.1 million, or $0.06 er diluted share.

Celsion Corporation (Nasdaq: CLSN), a late stage biotechnology drug development company that is leveraging its heat sensitive liposomal technology platform to encapsulate and deliver high concentrations of proven chemotherapeutics, today announced that it would hold a conference call to discuss second quarter 2010 results at 11:00 a.m. ET on Tuesday, August 3, 2010.

Genta Incorporated (OTCBB: GETA) announced today that its Board of Directors has approved a one-for-one hundred reverse stock split of Genta' common stock, and that the split will be effective with the open of trading on August 2, 2010.

Gilead Sciences, Inc. (Nasdaq:GILD) today announced the closing of its sale of $1.1 billion aggregate principal amount of 1.00% convertible senior notes due 2014 and $1.1 billion aggregate principal amount of 1.625% convertible senior notes due 2016 to qualified institutional buyers in accordance with Rule 144A under the Securities Act of 1933, as amended.

GlaxoSmithKline (NYSE:GSK) announced today that the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has released the first lots of FluLaval [Influenza Virus Vaccine] allowing distribution in the U.S. to begin for the 2010-2011 flu season. GSK anticipates distribution of Fluarix [Influenza Virus Vaccine] to follow in the next several weeks.

Halozyme Therapeutics, Inc. (Nasdaq: HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today announced it plans to report second quarter 2010 financial results on Friday, August 6, 2010 before the open of the financial markets.

IDenta Corp. (PINKSHEETS: IDTA) EO Yaacov Shoham today issued the following statement concerning US retail marketing:  Mr. Shoham stated, "Through the efforts of Earthbound LLC, we have finally reached an agreement with a major US retailer to market and sale our drug detector kits.

LandStar, Inc.'s (PINK SHEETS:LDSR) main subsidiary is pleased to disclose the financial statements for the second quarter, January 1 - June 30, 2010 period.

McKesson Corporation (NYSE: MCK) today reported that revenues for the first quarter ended June 30, 2010 were $27.5 billion compared to $26.7 billion a year ago.

Merck & Co., Inc. (NYSE: MRK) today announced financial results for the second quarter of 2010.

MultiCell Technologies, Inc. (OTC Bulletin Board: MCET) has launched a new website with a fresh new look and updated information about discovery technology platforms and lead drug candidates. It also provides information to answer investors' most common questions.

Mylan Inc. (Nasdaq: MYL) today announced that it priced $300 million aggregate principal amount of Senior Notes due 2020 at an issue price of 105.5% with a coupon of 7.875%, or an effective yield to maturity of 7.087%.

NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today announced it will hold a conference call on Thursday, August 5, 2010 at 4:30 p.m. ET (1:30 p.m. PT) to report results for its second quarter ended June 30, 2010.

PharmAthene, Inc. (NYSE Amex:PIP), a biodefense company developing medical countermeasures against biological and chemical threats, today announced that on July 26, 2010 it received a letter from the NYSE Amex LLC, stating that PharmAthene is not in compliance with the continued listing standards specified in Sections 1003(a)(i), (ii) and (iii) of the NYSE Amex Company Guide, because it has stockholders' equity of less than $2.0 million, $4.0 million and $6.0 million and losses from continuing operations and/or net losses in two of its three most recent fiscal years, three of its four most recent fiscal years and its five most recent fiscal years, respectively.  

Senomyx, Inc. (NASDAQ: SNMX) will release its second quarter 2010 financial results on Thursday, August 5, 2010 before the opening of the U.S. financial markets.

Stellar Pharmaceuticals Inc. (OTCBB:SLXCF), a Canadian pharmaceutical developer and marketer of high quality, cost-effective products for select health care markets, today reported signing an license agreement with Laboratorios Inibsa, S.A. for the distribution and sale of one of its lead products, Uracyst® (a sterile sodium chondroitin sulfate solution, 2%) for the treatment of interstitial cystitis/painful bladder syndrome ("IC/PBS") in Spain.

Sunwin International Neutraceuticals, Inc. (OTCBB: SUWN), today reported results for the full fiscal year of 2010 ended April 30, 2010.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) today announced that the Competition Bureau in Canada has reached an agreement with Teva Canada Limited and the Mercale Group, carrying on business as ratiopharm, stating that they will not challenge the transaction and the Companies are free to close without competition-related risk.

Warner Chilcott plc (Nasdaq: WCRX) today announced a recapitalization pursuant to which it intends to incur, subject to market and other conditions, $2.25 billion of new debt to fund a special dividend to Warner Chilcott's ordinary shareholders of $8.50 per share, or approximately $2.15 billion in the aggregate.

WuXi PharmaTech (Cayman) Inc. (NYSE:WX), a leading pharmaceutical, biotechnology and medical device R&D outsourcing company with operations in China and the United States, today announced that it will release financial results for the second quarter of 2010 on Monday, August 2, 2010, before the U.S. market opens.

ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), a biopharmaceutical cancer company addressing unmet medical needs, today reported its financial results for the three months ended June 30, 2010 and provided an update on the Company's continued progress with its clinical programs.

ZOLL Medical Corporation (NasdaqGS: ZOLL), a manufacturer of resuscitation devices and software solutions, today announced that Richard A. Packer, its Chief Executive Officer and Jonathan Rennert, its President, will speak at 10:00 a.m. on Tuesday, August 3, 2010 in New York City, at the Wedbush Securities Life Sciences Best Ideas MAC Conference being held at the Le Parker Meridien Hotel, 118 West 57th Street, New York, NY 10019.

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