Business
BioRestorative Therapies Announces FDA Clearance of Phase 2 BRTX-100 Clinical Study Protocol Amendment
— Amendment replaces saline injections with sham injections in the control group — MELVILLE, N.Y., April 16, 2024 (GLOBE NEWSWIRE) -- BioRestorative
About this update from Biorestorative Therapies, Inc.
[{"type":"text","content":"— Amendment replaces saline injections with sham injections in the control group — MELVILLE, N.Y., April 16, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced that the U.S. Food and Drug Administration (“FDA”) has cleared an important amendment to the protocol of the ongoing Phase 2 study investigating the use of BRTX-100, the Company’s lead cell therapy candidate, in treating chronic lumbar disc disease (“cLDD”). The protocol amendment removes saline injection in the control arm of the study and replaces it with a sham injection. “The FDA clearance of this important amendment highlights our positive relationship with the agency, brings additional safety to our subject participants, and helps preclude the possibility of transient clinical outcomes in the control group, which can impact end of study readouts,” said Lance Alstodt, BioRestorative’s Chief Executive Officer. “To further clarify, control patients in our Phase 2 clinical trial will now have a needle placed in close proximity to the target disc, but the disc will not be pierced, nor will it have saline injected into it. This positive change in our protocol will not have any impact from a timing perspective, affirming our already established 2024 enrollment completion target.” 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. 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. About BioRestorative Therapies, Inc. BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders: • Disc/Spine Program (brtxDISC™): Our lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a person’s own) cultured mesenchymal stem cell...