Bio-Path
Holdings, Inc., a biotechnology service provider setting up a liposomal
delivery technology for nucleic acid cancer drugs, introduced that it really
has begun enrolling affected individuals into the fourth dose cohort in the
Phase I clinical trial of its lead product applicant, BP-100.1.01 (Liposomal
Grb-2), and that is being examined as a systemic therapy for blood cancers such
as acute myeloid leukemia (AML), chronic myelogenous leukemia (CML), acute
lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS). The Phase I
trial includes five cohorts altogether. The trial has been conducted at The
University of Texas MD Anderson Cancer Center.
Liposomal
Grb-2 is systemically served by intravenous injection. Within the fourth
cohort, affected individuals would receive a dose of 40 mg/m2 two times per
week for four weeks, for a whole of eight dosages. The present protocol
regarding the clinical trial has dose escalation of 5, 10, 20, 40 and 50 mg/m2.
The anticipated drug for therapy is 45 mg/m2 based upon preclinical research
studies in animals.
Earlier
this year, Bio-Path upgraded its formulation and drug supplier to fulfill
increased requirement for the drug. The step-up within the quantity of
Liposomal Grb-2 seemed to be necessary based upon promoted therapies for
affected individuals in the clinical trial, and of course the increased number
of affected individuals who, in the standard investigators' view, stabilized
from therapy along with Liposomal Grb-2 and was going to receive lengthy therapy.
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