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 provides an update from several clinical development
programs and a 2020 business overview.
“We enter 2020 with robust development plans to
commence several key clinical trials that are expected to advance
our DNAbilize antisense RNAi nanoparticle technology in a number of
important oncology indications for which there are limited
treatment options,” said Peter H. Nielsen, President and Chief
Executive Officer of Bio-Path. “We are excited to initiate a
number of important studies across our development pipeline and
anticipate reporting key clinical datapoints from those studies
later in the year.”
Phase 2 Study of Prexigebersen in
Untreated and Refractory/Resistant Acute Myeloid Leukemia (AML) and
High-Risk Myelodysplastic Syndrome (MDS) Patients
In March 2019, Bio-Path announced a revised
strategy for the Stage 2 portion of its Phase 2 clinical trial of
prexigebersen in combination with frontline chemotherapy.
Bio-Path’s amended Stage 2 of the Phase 2 clinical trial will treat
two cohorts of patients. The first cohort is to include
untreated AML patients as existed in the pre-amended trial but with
the addition of untreated, high-risk MDS patients. The second
cohort is to include refractory/relapsed AML patients and high-risk
MDS patients. Both cohorts of patients are planned to be
treated with the combination of prexigebersen, decitabine and
venetoclax. The Company is finalizing amendments to add this
combination treatment to Stage 2 of the Phase 2 clinical trial.
The first step in the revised strategy involved
testing the safety of the combination of prexigebersen and
decitabine. In November 2019, the Company announced
successful completion of this safety testing in AML and MDS
patients in Stage 2 of the Phase 2 clinical study. The safety
segment of Stage 2 of the Phase 2 clinical trial comprised six
evaluable patients who were treated with the combination of
prexigebersen and decitabine. Although the combination of
prexigebersen and decitabine is not the treatment currently planned
for the efficacy evaluation of Stage 2 of the Phase 2 clinical
trial, the efficacy profile in this safety segment of the study was
very encouraging, with 50% of patients having a response, including
two patients (33%) showing complete responses with incomplete
hematologic recovery and one patient (17%) showing partial
response. For reference, in this class of AML and MDS
patients, the complete response rate to treatment with decitabine
alone is approximately 20%. Some patients are continuing to
receive treatment.
The next step in this Stage 2 of the Phase 2
program will be the safety testing of prexigebersen in combination
with decitabine and venetoclax in six evaluable patients drawn from
either of the two cohorts of untreated AML and high-risk MDS
patients or relapsed/refractory AML and high-risk MDS
patients. The Company currently expects to initiate this
safety testing in the second quarter of 2020. Assuming successful
completion of this safety testing, the Company plans that it would
then initiate the efficacy testing of this triple combination in
the two cohorts of patients. In 2020, Bio-Path intends to
continue its efforts to expand the number of sites, including
European-based sites, to enhance patient enrollment.
The clinical design of the Stage 2 portion of
the Phase 2 clinical trial calls for an interim analysis of each
cohort’s results after each cohort has treated 19 evaluable
patients. If the results from either or both patient
cohorts exceed expectations for current standard-of-care therapy,
the Company expects that plans for a pivotal trial would be
discussed with the FDA.
Phase 2a Study of Prexigebersen to treat
Chronic Myeloid Leukemia (CML) in Tyrosine Kinase Inhibitor
Failures and Accelerated and Blast Phase CML Patients
Bio-Path plans to enroll patients in a Phase 2a
clinical study of prexigebersen in combination with the frontline
therapy, dasatinib, for the treatment of CML in tyrosine kinase
inhibitor failures and accelerated and blast phase patients in
2020. The trial is expected to be conducted at The University of
Texas MD Anderson Cancer Center as a potential salvage therapy for
accelerated and blast phase CML patients and will expand to other
sites if feasible. Recent advances in the treatment of
chronic phase CML patients with tyrosine inhibitors has limited the
availability of these patients for the Bio-Path Phase 2a. As
a result, the continuation of this study is being evaluated based
on the potential for patient availability and clinical trial site
expansion. If this Phase 2a study is advanced, it will
evaluate two cohorts of three evaluable patients at two doses (60
mg/m2 and 90 mg/m2) of prexigebersen in combination with
dasatinib.
Phase 1 Study of Prexigebersen in
Patients with Advanced Solid Tumors
In late 2019, Bio-Path filed an Investigational
New Drug (IND) application to initiate a Phase 1 clinical trial of
prexigebersen in patients with advanced solid tumors, including
ovarian and uterine, pancreatic and breast cancer. This trial is
expected to commence after the IND has been cleared by the FDA,
which we currently anticipate being in 2020, at several leading
cancer centers and will evaluate the safety of prexigebersen in
these patients. Assuming positive Phase 1 results, the
Company expects it would advance to a Phase 1b clinical trial of
prexigebersen in combination with frontline therapy in these same
advanced solid tumor patients.
Phase 1 Study of BP1002 in Refractory or
Relapsed Lymphoma Patients and Chronic Lymphocytic Leukemia
Patients
In November 2019 the FDA cleared the IND for
BP1002 (liposomal Bcl-2), the Company’s second drug candidate, to
begin a Phase 1 clinical trial to evaluate BP1002 as a treatment
for refractory/relapsed lymphoma and chronic lymphocytic leukemia
patients. This study is expected to commence in the first
half of 2020 and is expected to be conducted at several premier
oncology centers, including the University of Texas MD Anderson
Cancer Center, and is planned to evaluate the safety of BP1002 in
several dose escalating cohorts to determine a maximum tolerated
dose.
Preclinical Development of
BP1003
The Company continues to advance its third
investigational drug candidate, BP1003, for the treatment of
advanced solid tumors, including pancreatic cancer. BP1003 is an
antisense RNAi nanoparticle targeting the Stat3 protein.
In 2020 Bio-Path expects to complete several
IND-enabling studies for BP1003. If those studies are
successful, Bio-Path expects that it would file an IND in late 2020
for the first-in-humans Phase 1 study of BP1003 in patients with
refractory/metastatic solid tumors including pancreatic, non-small
cell lung cancer, and colorectal cancers.
BP1003 has demonstrated efficacy in combination
with frontline therapies in animals against pancreatic
tumors.
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 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 will be evaluated in
lymphoma and solid tumors 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 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
212-362-1200will@sternir.com
Doug Morris Investor Relations Bio-Path
Holdings, Inc. 832-742-1369
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