Bio-Path Holdings, Inc., (OTCQX: BPTH) ("Bio-Path"), a biotechnology company developing a liposomal delivery technology for nucleic acid cancer drugs, today announced it is initiating development of its lead cancer drug BP-100-1.01 (Liposomal Grb-2) to treat triple negative breast cancer (TNBC) and inflammatory breast cancer (IBC), two cancers characterized by formation of aggressive tumors and relatively high mortality rates. Bio-Path is currently evaluating Liposomal Grb-2 in a Phase I clinical trial as a systemic treatment for blood cancers including acute myeloid leukemia (AML), chronic myelogenous leukemia (CML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS). The trial is being conducted at The University of Texas MD Anderson Cancer Center (MD Anderson Cancer Center).
Bio-Path has been in discussions over the last six months with senior breast cancer researchers at the MD Anderson Cancer Center regarding the potential of its lead drug candidate Liposomal Grb-2 to treat TNBC and IBC. These researchers have made a strong scientific case that blocking over-expression of the Grb-2 protein using Bio-Path's drug candidate Liposomal Grb-2 has the potential to be an effective treatment for TNBC and IBC. Grb-2 is an adaptor protein that acts as a critical linker between growth factor receptors and the RAS pathway, a pathway commonly activated in cancer. TNBC and IBC often over-express multiple growth factor tyrosine kinase receptors involved in growth proliferation, survival and invasion. These are important tyrosine kinases involved in TNBC and IBC progression and have been shown to utilize the Grb-2 protein in their signaling pathways. Bio-Path's drug candidate Liposomal Grb-2 has an antisense drug substance that prevents the cell from producing the Grb-2 protein. In addition, since Grb-2 is involved in multiple cancer signaling pathways, blocking Grb-2 provides multiple opportunities to interrupt or limit tumor progression.
Bio-Path's plan is to develop Liposomal Grb-2 as a targeted therapy against TNBC and IBC. Treatment goals are two-pronged: the first being to develop Liposomal Grb-2 as a tumor reduction agent in combination with other approved drugs in pre-operative settings, and the second is to develop Liposomal Grb-2 as a drug to treat and control or eliminate cancer metastasis in TNBC and IBC patients. Both of these treatment goals address high need situations for patients.
The developmental plan will be comprised of preclinical testing in cell lines to determine the inhibitory effects of Liposomal Grb-2 on cell growth and invasion. From there, preclinical studies in TNBC and IBC animal models would study Liposomal Grb-2 suppressive effects on tumor growth and tumor metastasis in these cancers. If the preclinical studies confirm benefit, Bio-Path anticipates that it would then proceed to a Phase I clinical trial. The Phase I trial could progress relatively quickly since the toxicity profile of Liposomal Grb-2 is already being established in the Company's current Phase I trial in blood cancers. The preclinical programs are expected to start in 2013 and last one year, after which time the Phase I clinical trial could begin after FDA approval to proceed.
The plan is for Dr. Naoto T. Ueno, M.D., Ph.D., to be the lead researcher for the preclinical studies, which will be conducted at the MD Anderson Cancer Center. Dr. Ueno is a Professor at the MD Anderson Cancer Center, Executive Director of the Morgan Welch Inflammatory Breast Cancer Program and Chief, Section of Translational Breast Cancer Research.
"The potential of Liposomal Grb-2 as a frontline treatment for triple negative breast cancer and inflammatory breast cancer is a major new development for Bio-Path that has the opportunity to produce substantial value for the Company. Successful development of these applications will be of great benefit to TNBC and IBC patients who are afflicted with these two very aggressive forms of breast cancer. Further, the treatment goal for tumor inhibition and reduction in a pre-operative setting provides a potential pathway for rapid approval by the FDA of Liposomal Grb-2, while the longer term effects of controlling or eliminating metastasis will build long term use of our drug," commented Peter Nielsen, President and Chief Executive Officer of Bio-Path.
Mr. Nielsen continued, "Over the course of the next 12-months, Bio-Path will be developing Liposomal Grb-2 for treatments for three high priority disease areas, including TNBC, AML and MDS. In a recent September 2012 news release, MD Anderson Cancer Center announced a Moon Shots Program that was targeting eight cancers for intensive development of treatments; three of these targeted cancers are indications for which Bio-Path will be focusing its development efforts. Bio-Path's drug candidate Liposomal Grb-2 has what researchers describe as 'disruptive technology' and is a potential game changer that can make significant advances in these priority disease areas."