September 28, 2015 9:09am

BTX is enrolling in a clinical P1/2a dose-escalation study evaluating the safety and efficacy of OpRegen® for geographic atrophy (GA). BTX closed down on Friday and is down further -$0.46 or -13.14% after a $20.7 M financing notification in the premarket. What’s the song, years, tears and more financings!


 

The U.S. FDA has granted Fast Track designation for OpRegen®, a cell-based therapeutic product consisting of retinal pigment epithelial (RPE) cells designed to block the progression of the severe dry-form of age-related macular degeneration (AMD), a leading cause of blindness in an aging population.

 

Under an IND for “Retinal Pigment Epithelium (RPE) Cells derived from Allogenic Human Embryonic Stem Cells; Transplanted Subretinally” and after receiving approval from the Israel Ministry of Health, Cell Cure is now enrolling patients at Hadassah University Medical Center in Jerusalem, Israel, in a clinical P1/2a dose-escalation study evaluating the safety and efficacy of OpRegen® for geographic atrophy (GA), the severe stage of the dry form of age-related macular degeneration (dry-AMD).

 

The Bottom Line: The first patient was treated earlier this year and Cell Cure expects to provide interim data in early 2016. The FDA Fast Track designation determines that a drug fills an unmet medical need in a serious condition. According to the FDA, a drug that receives Fast Track designation eligibility is based on a number of filings and submittals – but, the treatment must get beyond this P1/2a or even a P3 to end-up with a capability to advance. 

Investors are only focusing on the successive financings - BTX is spread a little  - TOO THIN across too many platforms!