Bio-Path Holdings Announces First Patient Dosed in Phase 1 Clinical Trial of BP1002
November 19 2020 - 7:00AM
Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company
leveraging its proprietary DNAbilize™ liposomal delivery and
antisense technology to develop a portfolio of targeted nucleic
acid cancer drugs, today announced the enrollment and dosing of the
first patient in a Phase 1 clinical trial evaluating the ability of
BP1002 to treat refractory/relapsed lymphoma and chronic
lymphocytic leukemia (CLL) 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 CLL or with relapsed, aggressive
non-Hodgkin’s lymphoma. Preclinical studies have shown BP1002 to be
a potent inhibitor against the Bcl-2 target, and the Company
believes that its benign safety profile should enable BP1002
combination therapy with approved agents.
A total of six evaluable patients will be treated with BP1002
monotherapy in a standard 3+3 design, with a starting dose of 20
mg/m2. The treatment cycle consists of two doses per week over four
weeks, resulting in eight doses administered over twenty-eight
days. The primary objectives of the study include safety and
tolerability of escalating doses of BP1002, recommended Phase 2
dose of BP1002, pharmacokinetics of BP1002 and BP1002 activity on
Bcl-2 expression. Secondary endpoints include several efficacy
measurements of tumor response.
“This study will mark a critical step in understanding the
potential benefits that BP1002 may bring to patients suffering with
advanced lymphoid malignancies,” 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 a much-needed alternative for patients with malignancies
that relapsed or are refractory to venetoclax.”
“We are delighted to initiate this first-in-human clinical study
of our second drug product candidate derived from the DNAbilize
platform. Given the encouraging pre-clinical data and safety
profile seen to date, we are very excited to begin this study,
which is expected to demonstrate safety and to show initial
efficacy signals in these indications with significant unmet
medical need,” said Peter Nielsen, President and Chief Executive
Officer of Bio-Path Holdings.
Ian W. Flynn, M.D. will serve as the national coordinating
Principal Investigator for the Phase 1 trial. Dr. Flynn is the
director of lymphoma research at the Sarah Cannon Research
Institute. Other sites for the clinical trial include the Georgia
Cancer Center at Augusta University and The University of Texas
M.D. Anderson Cancer Center.
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 infusion.
Bio-Path’s lead product candidate, prexigebersen (BP1001, targeting
the Grb2 protein), is in a Phase 2 study for blood cancers and
prexigebersen-A, a drug product modification of prexigebersen, is
under consideration by the FDA to commence Phase 1 studies in solid
tumors. This is followed by BP1002, targeting the Bcl-2 protein,
where it is being evaluated in lymphoma clinical studies.
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 the
impact, risks and uncertainties related to COVID-19 and actions
taken by governmental authorities or others in connection
therewith, 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 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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