NEW YORK – Bio-Path Holdings has dosed the first patient in its Phase I clinical trial evaluating BP1002, a BCL-2 inhibitor, as a treatment for refractory/relapsed lymphoma and chronic lymphocytic leukemia (CLL) patients.
The trial has enrolled six patients to evaluate BP1002 as a monotherapy. The primary endpoints are determining the safety and tolerability of escalating doses of BP1002, the recommended Phase 2 dose of BP1002, pharmacokinetics of BP1002, and BP1002 activity on BCL-2 expression. Secondary endpoints are measurements of tumor response.
"This study will mark a critical step in understanding the potential benefits that BP1002 may bring to patients suffering with advanced lymphoid malignancies," Jorge Cortes, chairman of Bio-Path's scientific advisory board, said in a statement. "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 a much-needed alternative for patients with malignancies that relapsed or are refractory to venetoclax."
BP1002 is the third investigational drug developed using Bio-Path's DNAbilize platform. The company's lead candidate prexigebersen, a GRB-2 inhibitor, is currently being studied in a Phase II trial to treat acute myeloid leukemia and chronic myeloid leukemia patients. Bio-Path is also seeking approval to begin trials of prexigebersen in solid tumors.