Geron Delay Dulls Stem Cell Sector (GERN, ASTM, CYTX, NBS, STEM, KOOL, OSIR, LIFE, CCEL)
Geron Corporation (NASDAQ: GERN) has some bad news in the land of stem cell investors. The stem cell leader has announced that its Investigational New Drug application for a cell therapy for neurologically complete, subacute spinal cord injury has been placed on clinical hold by the FDA pending the agency’s review of new nonclinical animal study data submitted by the company. This is an order that the FDA issues to a sponsor to delay a proposed trial or to suspend an ongoing trial.
As a reminder, no patients have yet been treated in this study. But this has investors spooked, even if it is just for a review of additional data. Stem Cell stocks often move hand in hand, and these are the other issues to watch on the news:
- Aastrom Biosciences, Inc. (NASDAQ: ASTM)
- Cytori Therapeutics, Inc. (NASDAQ: CYTX)
- Neostem, Inc. (NYSE: NBS)
- StemCells Inc. (NASDAQ: STEM)
- Thermogenesis Corp. (NASDAQ: KOOL)
- Osiris Therapeutics, Inc. (NASDAQ: OSIR)
- Life Technologies Corporation (NASDAQ: LIFE)
- Cryo-Cell International, Inc. (OTC Bulletin Board: CCEL)
Geron noted that the company has been undertaking studies to enable dose escalation of its spinal cord injury product and has also been investigating application of the product to other neurodegenerative diseases.
The company has also been performing additional product characterization and conducting further animal studies and the data from this work has been submitted to the FDA. Geron said that it will work closely with the FDA to facilitate the review of the new data and to release the clinical hold.
JON C. OGG
AUGUST 18, 2009
