Bio-Path Holdings Receives FDA Clearance for BP1002

Bio-Path Holdings (NASDAQ:BPTH) has announced that the US Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug Application for BP1002.

As quoted in the press release:

An initial Phase 1 clinical trial will evaluate the ability of BP1002 to treat refractory/relapsed lymphoma and chronic lymphocytic leukemia patients.

BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. High expression of Bcl-2 has been correlated with adverse prognosis for patients diagnosed with relapsed, aggressive non-Hodgkin’s lymphoma. Preclinical studies have shown BP1002 to be a potent inhibitor against the Bcl-2 target, and its benign safety profile should enable BP1002 combination therapy with approved agents.

“With this IND submission now accepted by the FDA, the path is now cleared for us to advance our important first-in-human clinical work for BP1002 in cancers with unmet medical need,” said Jorge Cortes, M.D., Director of the Georgia Cancer Center and Chairman of the Bio-Path Scientific Advisory Board. “Importantly, BP1002 activity is based on blocking the Bcl-2 messenger RNA and not the BH3 domain, as is the case with venetoclax. As a result, we believe BP1002 may provide an alternative for relapsed venetoclax patients.”

The Phase 1 clinical trial is expected to be conducted at several leading cancer centers, including The University of Texas MD Anderson Cancer Center and the Georgia Cancer Center. Initially, a total of six evaluable patients are scheduled to be treated with BP1002 monotherapy in a standard 3+3 design, with a starting dose of 20 mg/m². The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over twenty-eight days.

William G. Wierda, M.D., Ph.D. will serve as Principal Investigator for the trial. Dr. Wierda is a Professor and Center Medical Director for the Department of Leukemia at The University of Texas MD Anderson Cancer Center. Dr. Wierda also serves as Section Chief – Chronic Lymphocytic Leukemia in the Department of Leukemia at MD Anderson.

Click here to read the full press release.