Bio-Path Holdings has started patient enrolment in the fourth dosage cohort of a Phase I clinical trial of BP-100.1.01 (Liposomal Grb-2) in leukemias.
BP-100.1.01 (Liposomal Grb-2, systemically delivered by intravenous injection) will be evaluated as a systemic treatment for blood cancers, including acute myeloid leukemia, chronic myelogenous leukemia, acute lymphoblastic leukemia and myelodysplastic syndrome.
The Phase I trial which is being conducted at The University of Texas MD Anderson Cancer Center includes five cohorts in total.
Bio-Path president and chief executive officer Peter Nielsen said the arrival of the latest batch of drug product from the new supply chain and the opening of the fourth cohort of the clinical trial are important steps for the company.
"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," Nielsen added.
The patients will receive 40mg/m² twice a week dose for four weeks, for a total of eight doses, in the fourth cohort.
The current protocol for the trial includes dose escalation of 5mg/m², 10mg/m², 20mg/m², 40mg/m² and 50mg/m², while the expected dose for treatment is 45mg/m² based on preclinical studies in animals.
Bio-Path upgraded its substance and drug supplier based upon estimated treatments for patients in the trial, and the increased number of patients who, in the principle investigators' opinion, stabilised from treatment with Liposomal Grb-2 and were to receive extended treatment.