BioRestorative Therapies (NASDAQ:BRTX) has announced that the FDA has granted Fast Track designation to the BRTX-100 stem cell program for the treatment of chronic lumbar disc disease (cLDD).
“We are thrilled that the FDA has granted Fast Track designation, underscoring the potential of BRTX-100 to fill significant unmet medical needs in the treatment of cLDD resulting from ineffective conservative non-surgical approaches or failed surgical interventions, and reflecting the comparatively very positive preliminary Phase 2 clinical data that we have reported to date,” Lance Alstodt, CEO of BioRestorative, said in a statement.
“Achieving Fast Track designation is an important milestone for BioRestorative, enabling us to work more collaboratively with the FDA as we continue to advance our lead BRTX-100 clinical program toward BLA approval to bring this important and novel stem cell therapy to the millions of cLDD patients waiting for effective pain relief and functional improvement.”
BRTX-100, a novel cell-based therapeutic engineered to target areas of the body that have little blood flow, is BioRestorative’s lead clinical candidate. The safety and efficacy of BRTX-100 in treating cLDD is being evaluated in a Phase 2, prospective, randomized, double-blinded and controlled study. A total of up to 99 eligible subjects will be enrolled at up to 16 clinical sites in the United States. Subjects included in the trial will be randomized 2:1 to receive either BRTX-100 or placebo. Further details of the trial can be found at clinicaltrials.gov under NCT identifier: NCT04042844.
