MELVILLE, NY / ACCESSWIRE / July 7, 2023 / BioRestorative Therapies Inc. (NASDAQ:BRTX) has received a unanimous recommendation to proceed in its Phase 2 clinical trial for chronic lumbar disc disease, BRTX-100. The independent review body Data Safety Monitoring Board (DSMB) which is overseeing dose and safety related issues during the course of the trial approved the trial's continuation with no changes to the current version of the protocol.
This is the highest distinction given by the DSMB, which can recommend continuation without changes to the protocol, continuation with changes, or a suspension or termination of the trial. BioRestorative received unanimous approval from the DSMB to continue with no changes.
The safety data reviewed by the DSMB to determine if there was any toxicity related to dosing was taken from three patients who received BRTX-100, an injection of 40,000,000 hypoxic cultured mesenchymal stem cells formulated with autologous platelet lysate, while a fourth received an injection of saline placebo. There were no severe adverse events that were correlated to dose limiting toxicity( DLTs). The blinded results showed some of the patients experienced a reduction of pain and an increase in function.
BioRestorative Looks Ahead
BioRestorative can now begin moving ahead with the next stage of the trial. The study will start the open enrollment of the balance of the 99 patients. BRTX-100 is a cellular therapy injection developed from autologous hypoxic cultured mesenchymal stem cells which are taken from the patient's own bone marrow and formulated with autologous platelet lysate.
Now that there is initial confirmation about the drug's safety profile, the company plans to build out its platform technology. It is excited to begin examining other applications the drug may have in different parts of the body.
The company plans to advance the expansion of the platform by leveraging the safety and efficacy data from BRTX-100s trials, as well as assisting KOLs in investigator-initiated studies and small-subject studies. It will be looking at the treatment's potential indications in other avascular zones (areas in the body with little blood flow). The cervical area and the meniscus, as well as the hips, the shoulders and the extremities could be potential areas of focus.
"This unanimous recommendation of the DSMB to allow BioRestorative to proceed without any changes to the protocol represents a significant binary outcome and major milestone for the continuation of our clinical program," said Lance Alstodt, CEO of BioRestorative Therapies.
He continued, "With the safety profile of BRTX-100 now established through the DSMB process, we intend to accelerate the enrollment of the balance of our 99-patient study. In addition and more importantly, we intend to leverage the product technology platform across multiple indications further extending our pipeline opportunities."
With much to look ahead to, the company also has a stable funding position that allows it to advance through its next milestones, according to Lance. It finished Q1 of 2023 with over $12.7 million in capital.
Other companies involved in developing innovative cell therapies include Atherys, Inc., Brainstorm Therapeutics, and Mesoblast.
SOURCE: BioRestorative Therapies, Inc.
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