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 2 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 2. The expected dose for treatment is 45 mg/m 2 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.”