Bio-Path Holdings' liposomal Grb-2 IND receives FDA clearance to proceed into clinical trials

Bio-Path Holdings, Inc. (OTCBB: BPTH), a publicly traded biotechnology company with drug development operations in Houston, Texas, announced today that the U.S. Food and Drug Administration (FDA) has allowed an IND (Investigational New Drug) for the Company’s lead cancer drug candidate liposomal Grb-2 to proceed into clinical trials. The IND review process was performed by the FDA’s Division of Oncology Products and involved a comprehensive review of data submitted by the Company covering pre-clinical studies, safety, chemistry, manufacturing and controls, and the protocol for the Phase I clinical trial.

Bio-Path is developing a neutral lipid-based liposome delivery technology for nucleic acid cancer drugs (including antisense and siRNA molecules). The Company’s drug candidate liposomal Grb-2 (BP-100-1.01) is an antisense drug substance targeted to treat several types of cancer. The FDA’s clearance of the IND allows Bio-Path to proceed with a Phase I clinical trial in patients with chronic myelogenous leukemia (CML), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS). Commencement of the trial will occur after patients are enrolled and administrative details are finalized. The Company does not expect significant delays for these steps.

Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings, Inc. commented, “The granting of the IND represents a major milestone in the development of Bio-Path Holdings. As of today, Bio-Path has made the transition from a pre-clinical to a clinical-stage company. We look forward to commencing the Phase I clinical trial of liposomal Grb-2 and demonstrating the safety and effectiveness of Bio-Path’s neutral lipid delivery technology.”