HOUSTON, TX, USA I February 9 2015 I Bio-Path Holdings, Inc., (NASDAQ:BPTH) (“Bio-Path”), a biotechnology company developing a liposomal delivery technology for nucleic acid cancer drugs, today announced that it has begun enrollment into the safety segment of its Phase 2 study evaluating BP-100-1.01 (Liposomal Grb-2) in patients with acute myeloid leukemia (AML).

This segment of the study will evaluate two doses (60 mg/m2 and 90 mg/m2) of Liposomal Grb-2 in combination with Ara-C front line therapy. Each dose cohort will include three patients with AML for a total ofsix patients. The endpoint of this study segment is safety of the combination of the two drugs. The clinical trial is taking place at MD Anderson Cancer Center. Bio-Path expects results of this portion of the study in the second half of 2015.

“We are pleased to be moving Liposomal Grb-2 into the next phase of clinical development. This is a key milestone for Bio-Path and, after demonstrating a clean safety profile of the drug as a mono therapy, we are excited to evaluate the compound in its intended use in combination with an existing chemotherapeutic agent,” said Peter Nielsen, President and Chief Executive Officer of Bio-Path. “Upon successful completion of this safety segment and review by the FDA, we would then move into a broader efficacy segment of the study.”

About Bio-Path Holdings, Inc.

Bio-Path is a biotechnology company focused on developing therapeutic products utilizing its proprietary liposomal delivery technology designed to systemically distribute nucleic acid drugs throughout the human body with a simple intravenous transfusion. Bio-Path’s lead product candidate, Liposomal Grb-2, is in a Phase II study for blood cancers and in preclinical studies for triple negative and inflammatory breast cancers. Bio-Path’s second drug candidate, also a liposomal antisense drug, is ready for the clinic where it will be evaluated in lymphoma and solid tumors.

SOURCE: Bio-Path Holdings