<0> Bio-Path Holdings, Inc.Peter Nielsen, 832-971-6616President & Chief Executive OfficerorInstitutional Investors and AnalystsRx Communications Group, LLCRhonda Chiger, 917-322-2569orIndividual, Retail InvestorsPondel/Wilkinson Inc.Roger Pondel, 310-279-5980 </0>
Bio-Path Holdings, Inc., (OTCQX: BPTH) (“Bio-Path”), a biotechnology company developing a liposomal delivery technology for nucleic acid cancer drugs, today announced that it has begun enrolling patients into the fourth dosage cohort in its Phase I clinical trial of its lead product candidate, BP-100.1.01 (Liposomal Grb-2), which is being evaluated 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 Phase I trial will include five cohorts in total. The trial is being conducted at The University of Texas MD Anderson Cancer Center.
Liposomal Grb-2 is systemically delivered by intravenous injection. In the fourth cohort, patients will receive a dose of 40 mg/m twice a week for four weeks, for a total of eight doses. The current protocol for the clinical trial includes dose escalation of 5, 10, 20, 40 and 50 mg/m. The expected dose for treatment is 45 mg/m based on preclinical studies in animals.
Earlier this year, Bio-Path upgraded its substance and drug supplier to meet increased demand for the drug. The step-up in the supply of Liposomal Grb-2 was necessary based upon projected treatments for patients in the clinical trial, and the increased number of patients who, in the principle investigators’ opinion, stabilized from treatment with Liposomal Grb-2 and were to receive extended treatment.
“The arrival of the latest batch of drug product from our new supply chain and the opening of the fourth cohort of our clinical trial are important steps for the Company,” said Peter Nielsen, President and Chief Executive Officer of Bio-Path. “Establishing the new, higher capacity supply chain for our drug candidate was an essential step to ensure adequate future supply needed to support increased usage of Liposomal Grb-2 in blood cancers, as well as treatments for other cancer indications that may be developed.”
Bio-Path’s drug delivery technology involves microscopic-sized liposome particles that distribute nucleic acid drugs systemically and safely throughout the human body, via simple intravenous infusion. The delivery technology can be applied both to single stranded (antisense) nucleic acid compounds and double stranded (siRNA) with the potential to revolutionize the treatment of cancer and other diseases where drugable targets of disease are well characterized. The Company’s current focus is on developing liposomal antisense drug candidates. Bio-Path also anticipates developing liposome tumor targeting technology, representing next-generation enhancements to the Company’s core liposome delivery technology.
The adaptor protein Growth Receptor Bound protein-2 (Grb-2) is essential to cancer cell signaling because it is utilized by oncogenic tyrosine kinases to induce cancer progression. Suppressing the function or expression of Grb-2 should interrupt its vital signaling function and have a therapeutic application in cancer. BP-100.1.01is a neutral-charge, liposome-incorporated antisense drug substance designed to inhibit Grb-2 expression.
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 I study for blood 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.
For more information, please visit the Company's website at .