Biotechnology company Bio-Path Holdings, Inc. (BPTH) announced Monday that the U.S. Food and Drug Administration (FDA) has reviewed and cleared the Investigational New Drug (IND) application for BP1002 (liposomal Bcl-2), the Company’s second drug candidate.<\/p>\n
The IND application was for an initial Phase 1\/ 1b clinical trial that will evaluate the ability of BP1002 to treat refractory\/relapsed acute myeloid leukemia (AML) patients.<\/p>\n
The IND application was cleared based after a comprehensive review of data submitted by the Company covering pre-clinical studies, safety, chemistry, manufacturing and controls, and the protocol for the Phase 1\/1b clinical trial.<\/p>\n
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, such as decitabine.<\/p>\n
By targeting Bcl-2 at the DNA level rather than the protein, BP1002 might overcome and prevent some of the mechanisms of resistance that affect venetoclax.<\/p>\n
The Phase 1\/1b clinical trial is anticipated to be conducted at several leading cancer centers in the United States. 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.<\/p>\n
The Phase 1b portion of the study will commence after completion of BP1002 monotherapy cohorts and will assess the safety and efficacy of BP1002 in combination with decitabine in refractory\/relapsed AML patients. <\/p>\n