STEM ($STEM): AMD N=16 Trial gets the Green Light from the FDA
Stem Cells, Inc. (NASDAQ: STEM) gets the "green light" from the FDA to kick off a Phase I/II clinical trial of HuCNS-SC in AMD.
The Phase I/II trial will evaluate the safety and preliminary efficacy of HuCNS-SC cells as a treatment for dry AMD. While there are now therapeutic options for wet AMD there is no treatment for dry. The promise of cell therapy in this space is great. Advanced Cell Therapy (ACTC) is also pursuing this indication.
In the case of STEM, the trial will be an open-label, dose-escalation study, approx. N=16. STEM's HuCNS-SC cells will be administered by a single injection into the space beneath the retina. Patients' vision will be evaluated using conventional methods of ophthalmological assessment at predetermined intervals over a one-year period. Patients will then be followed for an additional four years in a separate observational study.
Daily Dose Conclusion: AMD is a promising area as the physical space in the eye is small and the market opportunity is large. The ability to rebuild rods & cones and restore vision is great. Several firms such as ACTC are working in the area. The key question for investors who have been patient with STEM for years and have lived through the most recent raise and reverse stock split: Is there a way back ? With Geron's (GERN) departure STEM is one of the only remaining embryonic (public) company left in the space. STEM is also pursuing the "holy grail" with a spine trial. Certainly the bet here is that STEM hits it big at some point but data is not immediate.
See all $STEM articles @ Daily Dose.
$stem, actc, gern, geron, stem | Print Article Email Article Posted on Thursday, February 2, 2012 at 9:21AM Permalink in Regenerative Medicine