Bio-Path Holdings Announces Completion of First Dose Cohort in Phase 1 Clinical Trial Evaluating BP1002 to Treat Refractory/Relapsed Lymphoma and Refractory/Relapsed Chronic Lymphocytic Leukemia Patients
January 10 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 first dose cohort of the
dose escalation portion of its Phase 1 clinical trial of BP1002
evaluating the ability of BP1002, a liposomal Bcl-2 nanoparticle
antisense, for the treatment of refractory/relapsed lymphoma and
refractory/relapsed chronic lymphocytic leukemia (CLL)
patients.
“We are delighted to safely complete this first
dose cohort and to advance BP1002 into the next cohort as it brings
us one step closer to providing access to this very promising
treatment for the most vulnerable patients who have limited
therapeutic options,” said Peter Nielsen, President and Chief
Executive Officer of Bio-Path Holdings. “We look forward to
advancing this study into higher dose cohorts with the expectation
that increased levels of BP1002 will prove even more efficacious
and continue its safety profile in these sickest of sick
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 Bio-Path believes that its
benign safety profile should enable BP1002 combination therapy with
approved agents.
In the Phase 1 trial, refractory/relapsed CLL
patients, including those who have failed or relapsed from
venetoclax-based frontline therapy, as well as refractory/relapsed
lymphoma patients, will be treated with BP1002. Venetoclax targets
the Bcl-2 protein based on neutralizing the protein’s BH3 domain
and is a frontline treatment for CLL patients and newly diagnosed,
elderly acute myeloid leukemia (AML) patients. With the exception
of some patients treated with allogeneic hematopoietic cell
transplantation, patients treated with venetoclax-based therapies
frequently relapse, primarily due to BH3 domain mutations over
time. Bio-Path’s BP1002 also targets the Bcl-2 protein, but its
activity is based on blocking the Bcl-2 messenger RNA and the
expression of the Bcl-2 protein, and not the BH3 domain. As a
result, Bio-Path believes that BP1002 could provide an alternative
treatment for venetoclax refractory/relapsed CLL patients. Bio-Path
also believes there may be AML patients who fail or relapse from
venetoclax-based frontline treatment for the same reason,
potentially representing an additional opportunity for Bio-Path to
treat those patients with BP1002.
The Phase 1 clinical trial is being conducted at
several leading cancer centers, including the Georgia Cancer
Center, The University of Texas Southwest and New York Medical
College. Locke Bryan, M.D., Associate Professor of Medicine at the
Georgia Cancer Center, is serving as National Principal
Investigator for the Phase 1 trial. 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 approved treatment
cycle is two doses per week over four weeks, resulting in eight
doses administered over 28 days. Enrollment is now open for
patients for the second dose cohort of 40 mg/m2. The primary
objective of the study is to evaluate the safety and tolerability
of escalating doses of BP1002.
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,
Inc.212-362-1200will@sternir.com
Doug Morris Investor Relations Bio-Path
Holdings, Inc. 832-742-1369
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