BioRestorative Therapies reports Phase 2 BRTX-100 clinical data

BioRestorative Therapies (BRTX) announced new preliminary 26-52 week blinded data from the first 10 patients with chronic lumbar disc disease, cLDD, enrolled in the ongoing Phase 2 clinical trial of BRTX-100. BRTX-100, a novel cell-based therapeutic engineered to target areas of the body that have little blood flow, is the Company’s lead clinical candidate. No serious adverse events were reported in any of the 10 safety run-in subjects. Notably, there was also no dose limiting toxicity at 26-52 weeks. In addition to the aforementioned preliminary primary safety endpoint data, the Company reported blinded clinical data on the secondary efficacy endpoint of at least a 30% decrease in pain as measured on the Visual Analog Scale at least a 30% increase in function based on the Oswestry Disability Index at week 52. The blinded preliminary efficacy endpoint data demonstrated: At 26 weeks, 70% of subjects reported a greater than30% improvement in VAS versus baseline; At 52 weeks, 100% of subjects reported a greater than30% improvement in VAS versus baseline; At 12 and 26 weeks, 70% of subjects had a greater than30% improvement in ODI versus baseline; At 52 weeks, 100% of subjects had a greater than30% improvement in ODI versus baseline; and At 26 weeks, 70% of subjects reported a greater than30% decrease in pain and a greater than30% increase in function.