Bio-Path Holdings Announces Successful Completion of Safety Cohort of Triple Combination of Prexigebersen, Decitabine and Ven...
April 05 2021 - 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 the successful completion of the safety
run-in of the Stage 2 of the Phase 2 clinical study of
prexigebersen (BP1001), a liposomal Grb2 antisense, for the
treatment of acute myeloid leukemia (AML), in combination with
frontline therapies, decitabine and venetoclax, in acute myeloid
leukemia (AML) patients. The safety run-in of Stage 2 of the Phase
2 clinical trial was comprised of six evaluable patients who were
treated with the triple combination of prexigebersen, decitabine
and venetoclax.
“We are particularly pleased with the clean side
effect profile and lack of toxicity shown in this segment of the
study, as our Phase 2 efficacy segment will include de novo fragile
AML patients for whom drug side effect profiles are particularly
important. We are also very encouraged by the efficacy signals
shown in this dataset, with five of six evaluable relapsed,
refractory and newly diagnosed AML patients demonstrating clinical
activity. These positive signals give us further confidence in the
potential for this program in these late-stage and compromised
patients,” stated Peter H. Nielsen, Chief Executive Officer of
Bio-Path Holdings.
“We look forward to advancing this Phase 2
study, as we believe its unique design provides us with several
definable registration pathways. We believe that prexigebersen,
with its promising efficacy and safety profile, has the potential
to be an ideal combination candidate with frontline therapies,”
concluded Mr. Nielsen.
In the safety run-in, six evaluable patients
were treated with the combination of prexigebersen, decitabine and
venetoclax. These patients included four relapsed/refractory AML
patients, and two newly diagnosed AML patients. In the preliminary
safety data review, five of the patients (83%) responded to
treatment, including four (67%) achieving complete response (CR)
and one (17%) complete response with incomplete hematologic
recovery (CRi). CR rates to combination treatment with decitabine
and venetoclax for relapsed/refractory AML patients is 42-52%1,2
and 0-39%1,2 for relapsed/refractory secondary AML patients.
Response rates to frontline treatment decitabine and venetoclax for
newly diagnosed AML patients is 62-71%3,4. These preliminary data
showed the treatment was well-tolerated and there were no dose
limiting toxicities attributed to prexigebersen. Three patients
remained on treatment for more than one cycle.
Stage 2 of the Phase 2 clinical trial has three
treatment cohorts, which the Company believes provides for several
potential regulatory pathways. The first two cohorts will treat
patients with the triple combination of prexigebersen, decitabine
and venetoclax. The first cohort includes newly diagnosed AML
patients and the second cohort includes relapsed/refractory AML
patients. Finally, the third cohort treats relapsed/refractory AML
patients who are venetoclax resistant or intolerant with the
two-drug combination of prexigebersen and decitabine.
The Phase 2 clinical trial continues with 21
patients currently enrolled across all three cohorts. Enrollment of
19 patients in each cohort should enable a data review to determine
if there is a comparative increase in efficacy versus the
decitabine and venetoclax combination therapy sufficient to support
petitioning the FDA for approval to switch to breakthrough therapy
for accelerated approval. The Phase 2 trial will be conducted at up
to ten clinical sites in the U.S. For more information
on the Phase 2 study, visit www.clinicaltrials.gov.
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 prexigebersen-A, a drug product
modification of prexigebersen, 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.
1) DiNardo et al. Lancet Haematology, 2020,
Oct;7(10):e724-e736.2) Aldoss et al. Haematol, 2018,
103:e404-e407.3) DiNardo et al. Blood, 2019, 133(1): 1-7.4)
Venclexta Package Insert.
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 the impact, risks and uncertainties
related to COVID-19 and actions taken by governmental authorities
or others in connection therewith, 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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