Bio-Path Holdings Announces Successful Completion of Higher Dose Second Cohort in Phase 1/1b Clinical Trial of BP1002 in Refractory/Relapsed Acute Myeloid Leukemia (AML) Patients
April 18 2024 - 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 completion of the second dose cohort of the
dose escalation portion of its Phase 1/1b clinical trial of BP1002
evaluating the ability of BP1002 to treat refractory/relapsed acute
myeloid leukemia (AML) patients, including venetoclax-resistant
patients.
“We are delighted to safely progress through the second, higher
dose cohort to reach an important study milestone for the United
States Food and Drug Administration (FDA) to review patient study
data,” said Peter Nielsen, President and Chief Executive Officer of
Bio-Path Holdings. “Enrollment rates have been good, and we look
forward to advancing this study in even higher doses with the hope
that we can sooner reach the combination therapy segment of our
Phase 1/1b study with increased levels of BP1002 for the treatment
of these vulnerable patients with few, if any, treatment
options.”
BP1002 targets the protein Bcl-2, which is responsible for
driving cell survival in up to 60% of all cancers. The current
standard of care for patients with AML not eligible for intensive
chemotherapy is venetoclax, an oral Bcl-2 inhibitor that targets
the BH3 domain of the Bcl-2 protein, in combination with a
hypomethylating agent or with low-dose cytarabine. However, many
patients become resistant to venetoclax treatment. A published
study found that AML patients who had relapsed from frontline
venetoclax-based treatment were refractory to salvage therapy and
had a median survival of less than 3 months. By targeting Bcl-2 at
the mRNA level rather than the protein, BP1002 may overcome and
prevent some of the mechanisms of resistance that affect venetoclax
treatment. Published preclinical Bio-Path studies have shown BP1002
to be a potent inhibitor against the Bcl-2 target, and we believe
that its benign safety profile should enable effective BP1002
combination therapy with approved agents, such as decitabine.
The Phase 1/1b clinical trial is being conducted at several
leading cancer centers in the United States, including the Weill
Medical College of Cornell University, The University of Texas MD
Anderson Cancer Center, Scripps Health, and The University of
California at Los Angeles Cancer Center. Initially, the dose
escalation portion of the clinical plan calls for a total of six
evaluable patients to be treated with BP1002 monotherapy over two
dose levels in a standard 3+3 design, with a starting dose of 20
mg/m2 and the second dose of 40 mg/m2. The testing of these two
dose levels is now complete and the clinical trial will pause for a
brief data review by the FDA, and then we expect that dose testing
will continue at the next planned higher dose of 60 mg/m2. The
approved treatment cycle is two doses per week over four weeks,
resulting in eight doses administered over twenty-eight days. The
Phase 1b portion of the study is expected to commence after
completion of BP1002 monotherapy cohorts and will assess the safety
and efficacy of BP1002 in combination with decitabine in
refractory/relapsed AML patients.
Gail J. Roboz, M.D., is the National Principal
Investigator for the Phase 1/1b trial. Dr. Roboz is a professor of
medicine and director of the Clinical and Translational Leukemia
Program at the Weill Medical College of Cornell University and
the New York-Presbyterian Hospital in New York City. Gary Schiller,
M.D., The University of California at Los Angeles Cancer Center,
Maro Ohanian, D.O., Department of Leukemia, University of Texas MD
Anderson Cancer Center, and David Hermel, M.D., Scripps Health, are
each serving as principal investigators.
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
blood cancers, and BP1001-A, a drug product modification of
prexigebersen, is in a Phase 1/1b study for solid tumors. The
Company’s second product, BP1002, which targets the Bcl-2 protein,
is being evaluated for the treatment of blood cancers and solid
tumors, including lymphoma and acute myeloid leukemia. 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.
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, have success in
the clinical development of its technologies, the timing of
enrollment and release of data in such clinical studies, 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 or
future patent applications will be issued or that any issued
patents will provide meaningful protection of our drug candidates,
the impact, risks and uncertainties related to global pandemics,
including the COVID-19 pandemic, and actions taken by governmental
authorities or others in connection therewith, 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
212-362-1200will@sternir.com
Doug Morris Investor Relations Bio-Path Holdings, Inc.
832-742-1369
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