Bio-Path Holdings Announces Successful Completion of Safety Testing in Stage 2 of Phase 2 Clinical Trial in Acute Myeloid Leu...
November 26 2019 - 8:00AM
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 announces the successful completion of the safety
testing of prexigebersen in combination with decitabine in acute
myeloid leukemia (AML) and myelodysplastic syndrome (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.
“We are especially pleased to have successfully
completed this key safety segment of our Phase 2 study as it allows
us to move forward to the next segment of this important clinical
study, which is the final, efficacy portion of Stage 2 of the Phase
2 study,” said Peter Nielsen, President and Chief Executive Officer
of Bio-Path Holdings. “We are in the process of completing the
documentation to submit for final approval of this last portion of
Stage 2 of the Phase 2 study. These results are encouraging
and give us greater confidence in the successful development of
this very promising combination therapy for AML and MDS
patients."
Although the treatment combination of prexigebersen
and decitabine is not the treatment 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 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.
As previously reported, Stage 1 of the Phase 2
clinical trial, which treated de novo AML patients with a
combination of low dose cytarabine (LDAC) and prexigebersen,
demonstrated similar safety results and efficacy compared favorably
to treatment of this class of patients with LDAC alone. We
believe that prexigebersen with its promising efficacy and safety
profile, has the potential to be an ideal combination candidate
with frontline therapy. The recent approval of the frontline
therapy venetoclax provided an opportunity for adding prexigebersen
to the combination of venetoclax and decitabine for the treatment
of AML and MDS patients. The first step in this process
was establishing the safety of combining prexigebersen and
decitabine prior to proceeding to a combination treatment of
prexigebersen, decitabine and venetoclax.
Bio-Path’s amended Stage 2 of the Phase 2 clinical
trial will have two cohorts of patients. The first cohort
will include untreated AML patients as existed in the pre-amended
trial but with the addition of untreated high risk MDS patients,
and a second cohort will include refractory/relapsed AML patients
and high risk MDS patients. Both cohorts of patients will 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.
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’s second product BP1002, which targets the Bcl-2 protein,
will be evaluated for the treatment of lymphoma and solid tumors.
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, 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, that patents relating to existing for future
patent applications will be issued or that any issued patents will
provide meaningful protection of our drug candidates, 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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