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
We have been partially fighting the urge to cover a relatively new angle on stem cell research for a while. Part of the resistance was due to the size and OTC-BB listing status of one of the companies we know of in the field, and part has been due to the actual process. Geron Corporation (NASDAQ: GERN) is our go-to stock for companies in the development of human embryonic stem cell based therapeutics, particularly after its recent deal with General Electric Co. (NYSE: GE). Neostem, Inc. (NYSE: NBS) is a company we have covered that has ties to stem cells from adults. The area we have been reluctant to cover is adult stem cell research from menstrual blood.
One company which has been active in the news that has been getting itself back on the map is Cryo-Cell International, Inc. (OTC Bulletin Board: CCEL). The company is small and its May balance sheet shows higher liabilities than assets. But the company is going to be presenting data on the proliferative ability of stem cells found in menstrual blood (MenSCs) and Cryo-Cell does have operations ongoing. It has also been public since the 1990′s and it has actually posted profits in the last three quarters.