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/m2
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/m2. The expected dose for treatment is 45 mg/m2
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."
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