Bio-Path Announces Patient Dosing in Amended Phase 2 Prexigebersen Trial in Acute Myeloid Leukemia
August 26 2019 - 7:00AM
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 patient dosing in Bio-Path’s amended Phase 2
trial of prexigebersen for the treatment of acute myeloid leukemia
(AML), as announced in March 2019.
The key change in the amended Phase 2 study is the inclusion of
patients with high risk myelodysplastic syndrome (MDS) and
refractory/relapsed AML patients. The restructured Phase 2 clinical
trial has two cohorts of patients. The first being untreated AML
patients as existed in the pre-amended trial but with the addition
of high risk MDS patients, and a second cohort comprised of
refractory/relapsed AML patients and high risk MDS
patients.
The amended Phase 2 study will continue evaluating the safety of
prexigebersen in combination with decitabine in both cohorts of
patients at a dose of 60 mg/m2 in combination with decitabine. The
study will include a total of six evaluable patients for a safety
assessment of prexigebersen and decitabine. To date, the Company
has enrolled five evaluable patients: three untreated AML patients
in who received therapy prior to amending the trial, and two
patients who are now being treated under the amended Phase 2 trial.
Assuming a successful completion of this safety assessment, the
study will then modify testing of both cohorts of patients to add
venetoclax to the prexigebersen/decitabine combination
treatment.
After a six-patient safety assessment of the
prexigebersen/decitabine/venetoclax combination, the Company
intends to commence the efficacy segment of this trial. It is
anticipated that each cohort will include an interim assessment of
19 evaluable patients that would assess whether the treatment
efficacy of the combination of prexigebersen/decitabine/ venetoclax
exceeds the efficacy of current standard-of-care therapy with
statistical significance. Upon such favorable data, Bio-Path would
petition the U.S. Food and Drug Administration (FDA) for
accelerated approval. The efficacy segment of the trial is expected
to be conducted at up to ten clinical sites in the United States.
Moving forward, the Company intends to evaluate potential clinical
sites in Europe with an emphasis on patient accruals.
“We are excited to have dosed the first patient in our amended
protocol of this important clinical trial, confident that the
changes made to the protocol, along with the inclusion of MDS
patients, will further demonstrate the potential of prexigebersen
in a number of cancer indications for which there are limited
treatment options,” said Peter Nielsen, President and Chief
Executive Officer of Bio-Path. “We are encouraged about the outcome
for this study, as preclinical work showed the benefit of
prexigebersen in combination with decitabine and venetoclax. We
look forward to advancing this development program with the goal of
bringing new therapies to cancer patients in need.”
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 is also
developing BP1002, which targets the Bcl-2 protein and is expected
to be evaluated for the treatment of lymphoma and solid tumors. In
addition, BP1003, a novel liposome-incorporated STAT3 antisense
oligodeoxynucleotide developed by Bio-Path as a specific inhibitor
of STAT3, is expected to enter Phase 1 studies 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,
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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