|[March 07, 2013]
Bio-Path Holdings Begins Enrollment in Fifth Cohort of Phase I Clinical Trial of Lead Product Candidate Liposomal Grb-2 in Leukemias
HOUSTON --(Business Wire)--
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 fifth 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
trial is being conducted at The University of Texas MD Anderson Cancer
Liposomal Grb-2 is systemically delivered by intravenous injection. In
the fifth cohort, patients will receive a dose of 60 mg/m2
twice a week for four weeks, for a total of eight doses. As the Company
reported in November, due to the favorable safety profile of Liposomal
Grb-2, we have expanded the Phase I clinical trial to include higher
dosages. Following the completion of the fifth cohort, Bio-Path expects
to enroll patients into a sixth cohort with a dosage of 90 mg/ m2.
The Company remains on track to complete dosing in the Phase I trial by
About Bio-Path's Delivery Technology
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 is applied to single stranded (antisense) nucleic acid
compounds with the potenial to revolutionize the treatment of cancer
and other diseases where drugable targets of disease are well
characterized. The Company is currently focused 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.
About Growth Receptor Bound Protein-2 (Grb-2)
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 Grb2 should interrupt its vital signaling function and
have a therapeutic application in cancer. BP-100.1.01 is a
neutral-charge, liposome-incorporated antisense drug substance designed
to inhibit Grb-2 expression.
About Bio-Path Holdings, Inc.
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.
Any statements that are not historical facts contained in this
release are forward-looking statements that involve risks and
uncertainties, including Bio-Path's ability to raise needed additional
capital on a timely basis in order for it to continue its operations,
have success in the clinical development of its technologies, the timing
of enrollment and release of data in such clinical studies and the
accuracy of such data, limited patient populations of early stage
clinical studies and the possibility that results from later stage
clinical trials with much larger patient populations may not be
consistent with earlier stage clinical trials, and such other risks
which are identified in the Company's most recent Annual Report on Form
10-K and in any subsequent quarterly reports on Form 10-Q. These
documents are available on request from Bio-Path Holdings or at www.sec.gov.
Bio-Path disclaims any intention or obligation to update or
revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
For more information, please visit the Company's website at http://www.biopathholdings.com.
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