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| 8-K - 8-K - BIO-PATH HOLDINGS INC | v191905_8k.htm |
Exhibit
99.1
Bio-Path
Holdings Announces Dosing of First Patient in a Phase I Clinical
Trial
of its Liposomal Grb-2 Cancer Drug Candidate
FOR
IMMEDIATE RELEASE
July 29, 2010 HOUSTON, TX –
Bio-Path Holdings, Inc., (OTC BB: BPTH) (“Bio-Path”), a biotechnology company
with drug development operations in Houston, Texas, announced today that the
first patient has been dosed in a Phase I study of its cancer drug candidate,
Liposomal Grb-2 (L-Grb-2 or BP-100-1.01), in patients with Acute Myeloid
Leukemia (AML), Chronic Myelogenous Leukemia (CML), Acute Lymphoblastic Leukemia
(ALL) or Myelodysplastic Syndrome (MDS). Bio-Path is developing a
neutral lipid-based liposome delivery technology for nucleic acid cancer drugs
(including antisense and siRNA molecules), a delivery technology that forms
microscopic-sized vehicles to safely deliver these drugs to their intended
target cancer cells.
Growth
factor receptor bound protein-2 (Grb-2) is an adaptor protein that has shown to
be involved with several types of cancer. The main function of Grb-2 is to
link activated tyrosine kinase to Ras activation. The Grb-2 gene is mapped
to the human chromosome region known to be duplicated in leukemia and solid
tumors, including breast cancer. The strategy employed using
Bio-Path’s L-Grb-2 antisense drug candidate is to inhibit Grb-2 expression in
the cell utilizing liposome-incorporated, nuclease-resistant antisense
oligonucleotides specific for Grb-2 messenger-RNA. The Grb-2
antisense molecule blocks binding of ribosomes to the Grb-2 mRNA, thereby
impairing Grb-2 protein production.
The Phase
I clinical trial is a dose-escalating study to determine the safety and
tolerance of escalating doses of L-Grb-2. The study will also
determine the optimal biologically active dose for further
development. The pharmacokinetics of L-Grb-2 in patients will be
studied, making it possible to investigate whether the delivery technology
performs as expected based on pre-clinical studies in animals. The
trial will evaluate five doses of L-Grb-2 and 18 to 30 patients may be accrued
into the study. The clinical trial is being conducted at The
University of Texas M. D. Anderson Cancer Center.
Peter
Nielsen, President and Chief Executive Officer of Bio-Path commented, “Liposomal
Grb-2 is the first cancer drug candidate in Bio-Path’s lipid vehicle delivery
platform to begin clinical trials, so this is a major step in the development of
the Company’s technology. Liposomal Grb-2 has the potential to become
a substantial cancer drug product. In addition to treating the
leukemia diseases in this trial, L-Grb-2 also has the potential to be developed
for treatment of breast cancer and other solid tumors.”
“A second
important outcome for the Phase I clinical trial is the ability to assess for
the first time the performance of the Company’s delivery technology platform in
human patients. Being platform technology, a successful demonstration
of the delivery technology in this study will allow the Company to immediately
begin expanding Bio-Path’s drug candidates by simply applying the delivery
technology template to multiple new drug product targets. In this
manner, Bio-Path can quickly build an attractive drug product pipeline with
multiple drug product candidates for treating cancer as well as treating other
important diseases including diabetes, cardiovascular conditions and
neuromuscular disorders.”
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 can be applied both to
double stranded (siRNA) and 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. Bio-Path also anticipates developing liposome
tumor targeting technology, representing next-generation enhancements to the
Company’s core liposome delivery technology.
About Bio-Path Holdings,
Inc.
Bio-Path
is a drug development company focused on developing products licensed to it from
The University of Texas M. D. Anderson Cancer Center for the treatment of
cancer.
The
Company is currently developing three cancer drug product candidates. The first
lead cancer drug product, L-Grb-2 (antisense), is currently being studied in a
Phase I human trial. Bio-Path’s second drug candidate, also an
antisense drug, is ready for the clinic, and its third candidate is a siRNA
cancer drug that is in the final pre-clinical development
stage.
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.
Contact
Information:
Peter
Nielsen
President
& Chief Executive Officer
Tel
832.971.6616