|[December 09, 2013]
Preliminary Results from Bio-Path Holdings' Phase I Clinical Trial Presented at the Annual Meeting of the American Society of Hematology (ASH) in New Orleans
HOUSTON --(Business Wire)--
Bio-Path Holdings, Inc., (OTCQX: BPTH) ("Bio-Path"), a biotechnology
company developing a liposomal delivery technology for nucleic acid
cancer drugs, announced that Dr. Jorge Cortes, deputy chair and
professor of medicine in the Department of Leukemia at The
University of Texas MD Anderson Cancer Center, presented Phase I
data from Bio-Path's clinical trial evaluating its lead product
candidate, Liposomal Grb-2 (BP-100-1.01), in hematological cancers at
the 55th Annual Meeting of the American Society of Hematology (ASH) in
The study titled "Safety, Pharmacokinetics, and Efficacy Of BP-100-1.01
(Liposomal Grb-2 Antisense Oligonucleotide) In Patients With Refractory
Or Relapsed Acute Myeloid Leukemia (AML), Philadelphia Chromosome
Positive Chronic Myelogenous Leukemia (CML), Acute Lymphoblastic
Leukemia (ALL), and Myelodysplastic Syndrome (MDS)" included the first
five cohorts of the study. The sixth cohort of the study is ongoing, and
Bio-Path expects to have enrollment completed in the first
quarter of 2014.
The clinical trial was a standard dose-finding study. The starting dose
was 5 mg/m2 twice weekly intravenously (IV) over two to three
hours for 28 days and proceeded through doses of 10, 20, 40, and 60 mg/m2.
A total of 28 patients who had failed other therapies were included in
the study (19 AML, 4 MDS and 5 CML), and 18 patients were evaluable. Ten
patients failed to complete the full 28-day treatment cycle due to
disease progression with no toxicity.
Data from the Phase I trial demonstrated:
Among 18 evaluable patients, nine experienced at least a 50 percent
reduction in peripheral or bone marrow blasts from baseline.
Five patients demonstrated transient improvement and/or stable
disease, three of whom received a total of five cycles each.
Two patients, in addition to achieving marked blast percentage
declines, also experienced transient improvement in leukemia cutis
Disease Stabilization in MDS and AML
Two patients with MDS, a 53-year-old male and a 72-year-old female,
both achieved disease stabilization and continued therapy for five
cycles before disease progression.
A 54-year-old HIV positive male with AML achieve stable disease and
marked reduction in peripheral blasts, continuing therapy for five
cycles before disease progression.
Experience in CML-Blast Phase
Patient with myeloid blast crisis of CML
Prior therapies consist of: imatinib, dastinib, nilotinib, DCC-2036,
Cytarabine + Fludarabine + Dasatinib + Gemtuzumab, PHA-739358,
Clofarabine + Dasatinib
Upon start of BP-100-1.01 patient showed a significant reduction in
blasts from 81 percent to 5 percent but due to leptomeningeal disease
progression discontinued therapy before full cycle.
Inhibition of Target (News - Alert) Grb-2 Protein
Grb-2 levels were compared to baseline prior to treatment.
On day 15, BP-100-1.01 decreased Grb-2 in five of eight samples tested
(average reduction 55 percent)
End of treatment day 15, BP-100-1.01 decreased Grb-2 levels in eight
out of nine patients (average reduction 45 percent)
Preliminary results suggest that BP-100-1.01 at doses up to 60 mg/m2
is well tolerated and there is suggestion of anti-leukemia activity.
Of the evaluable patients, all showed a transient drop in circulating
or bone marrow blast percentage.
Doses administered in Cohorts 1-5 expected to be below Optimal
As the study progresses it is anticipated that clearer signs of
activity will be noted.
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 potential 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 Grb-2 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 and in preclinical studies for triple negative and inflammatory
breast 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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