BioRestorative Therapies Inc BRTX has announced that the independent Data Safety Monitoring Board (DSMB), overseeing the company's ongoing Phase 2 trial to treat chronic lumbar disc disease, unanimously recommended the continuation of the study under the current version of the protocol with no changes.
The treated patients will receive BRTX-100, a product formulated from autologous (or a person's own) hypoxic cultured mesenchymal stem cells collected from the patient's bone marrow and autologous platelet lysate.
Earlier this month, BioRestorative announced that the final subject in its BRTX-100 Phase 2 trial safety cohort had been dosed. Four participants were dosed at a 3:1 ratio with BRTX-100 or control.
What Happened: Three patients in the safety run-in group received an intradiscal injection of 40,000,000 hypoxic cultured mesenchymal stem cells, and one received an injection of saline placebo.
This safety run-in was used to evaluate the safety and dose-limiting toxicity of BRTX-100.
No DLTs were observed within the safety run segment of the study.
The DSMB recommended that the company be permitted to commence open enrollment of the 99-patient study.
These additional patients (other than those receiving a placebo) will be treated with BRTX-100, which includes 40,000,000 hypoxic cultured mesenchymal stem cells.
In March, BioRestorative entered into an agreement with Bruder Consulting & Venture Group, a full-service strategic advisory, to assist the company in seeking FDA approval for the expanded clinical application of BRTX-100.
Price Action: BRTX shares are trading 5.86% higher at $6.87 during the premarket session on the last check Tuesday.
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