Bio-Path Holdings Announces Clearance of Investigational New Drug Application for BP1002
November 21 2019 - 8:00AM
Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company
leveraging its proprietary DNAbilize® antisense RNAi nanoparticle
technology to develop a portfolio of targeted nucleic acid cancer
drugs, today announced that the U.S. Food and Drug Administration
(FDA) has reviewed and cleared the Investigational New Drug (IND)
application for BP1002 (liposomal Bcl-2), the Company’s second drug
candidate. An initial Phase 1 clinical trial will evaluate the
ability of BP1002 to treat refractory/relapsed lymphoma and chronic
lymphocytic leukemia patients.
BP1002 targets the protein Bcl-2, which is responsible for
driving cell survival in up to 60% of all cancers. High expression
of Bcl-2 has been correlated with adverse prognosis for patients
diagnosed with relapsed, aggressive non-Hodgkin’s lymphoma.
Preclinical studies have shown BP1002 to be a potent inhibitor
against the Bcl-2 target, and its benign safety profile should
enable BP1002 combination therapy with approved agents.
“With this IND submission now accepted by the FDA, the path is
now cleared for us to advance our important first-in-human clinical
work for BP1002 in cancers with unmet medical need,” said Jorge
Cortes, M.D., Director of the Georgia Cancer Center and Chairman of
the Bio-Path Scientific Advisory Board. “Importantly, BP1002
activity is based on blocking the Bcl-2 messenger RNA and not the
BH3 domain, as is the case with venetoclax. As a result, we
believe BP1002 may provide an alternative for relapsed venetoclax
patients.”
The Phase 1 clinical trial is expected to be conducted at
several leading cancer centers, including The University of Texas
MD Anderson Cancer Center and the Georgia Cancer Center. Initially,
a total of six evaluable patients are scheduled to be treated with
BP1002 monotherapy in a standard 3+3 design, with a starting dose
of 20 mg/m2. The approved treatment cycle is two doses per week
over four weeks, resulting in eight doses administered over
twenty-eight days.
William G. Wierda, M.D., Ph.D. will serve as Principal
Investigator for the trial. Dr. Wierda is a Professor and Center
Medical Director for the Department of Leukemia at The University
of Texas MD Anderson Cancer Center. Dr. Wierda also serves as
Section Chief - Chronic Lymphocytic Leukemia in the Department of
Leukemia at MD Anderson.
“This IND clearance for BP1002 marks an important regulatory
milestone for Bio-Path, as we progress our second drug candidate
into the clinic. Given the encouraging pre-clinical data and safety
profile we have seen to-date, we are eager to begin this
first-in-human study,” said Peter Nielsen, President and Chief
Executive Officer of Bio-Path Holdings.
The IND review process was performed by the FDA’s Office of
Oncologic Diseases, Division of Hematologic Malignancies and
involved a comprehensive review of data submitted by the Company
covering pre-clinical studies, safety, chemistry, manufacturing and
controls, and the protocol for the Phase 1 clinical
trial.
About Bio-Path Holdings, Inc.
Bio-Path is a biotechnology company developing DNAbilize®, a
novel technology that has yielded a pipeline of RNAi nanoparticle
drugs that can be administered with a simple intravenous
transfusion. Bio-Path’s lead product candidate, prexigebersen
(BP1001, targeting the Grb2 protein), is in a Phase 2 study for the
treatment of blood cancers and is in the process of filing an IND
for a Phase 1 clinical trial for solid tumors. The Company’s second
product BP1002, which targets the Bcl-2 protein, will be evaluated
for the treatment of lymphoma and solid tumors. In addition, an IND
is expected to be filed for BP1003, a novel liposome-incorporated
STAT3 antisense oligodeoxynucleotide developed by Bio-Path as a
specific inhibitor of STAT3, in 2020.
For more information, please visit the Company's website at
http://www.biopathholdings.com.
Forward-Looking Statements
This press release contains forward-looking statements that are
made pursuant to the safe harbor provisions of the federal
securities laws. These statements are based on management's current
expectations and accordingly are subject to uncertainty and changes
in circumstances. Any express or implied statements contained in
this press release that are not statements of historical fact may
be deemed to be forward-looking statements. 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, Bio-Path's
ability to 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, the maintenance of intellectual property rights,
that patents relating to existing for future patent applications
will be issued or that any issued patents will provide meaningful
protection of our drug candidates, risks relating to maintaining
Bio-Path's listing on the Nasdaq Capital Market and such other
risks which are identified in Bio-Path's most recent Annual Report
on Form 10- K, in any subsequent quarterly reports on Form 10-Q and
in other reports that Bio-Path files with the Securities and
Exchange Commission from time to time. 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.
Contact Information:
Investors
Will O’ConnorStern Investor Relations,
Inc.212-362-1200will@sternir.com
Doug Morris Investor Relations Bio-Path
Holdings, Inc. 832-742-1369
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