Bio-Path Holdings Presents at 2020 American Society of Clinical Oncology Annual Meeting
May 29 2020 - 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 presentation of a poster highlighting
the clinical trial design of its Phase 2 study of BP1001
(prexigebersen) at the 2020 American Society of Clinical Oncology
(ASCO) Annual Meeting, taking place virtually from May 29-31, 2020.
The poster, titled, “A Phase II Study of BP1001 (liposomal Grb2
antisense oligonucleotide) in Patients with Hematologic
Malignancies,” was presented virtually by Dr. Maro Ohanian,
Department of Leukemia, University of Texas M.D. Anderson Cancer
Center. The poster describes the Phase 2 study design of BP1001
(liposomal Grb2 antisense), the Company’s lead drug candidate, in
combination with decitabine as a potential treatment for patients
diagnosed with acute myeloid leukemia (AML) or high-risk
myelodysplastic syndrome (MDS).
“This innovative trial design for BP1001 is unique in that it
allowed us to adjust our treatment to include newly approved
therapies that we believed would be enhanced from combination with
our DNAbilize technology. We believe this robust design will
provide for the best outcomes for patients and will be the most
expeditious route to bringing BP1001 to market. We are delighted to
have the design presented and expect that it will enhance
visibility for our DNAbilize platform and its versatility among an
audience dedicated to bringing new cancer treatments to patients,”
stated Peter Nielsen, President and Chief Executive Officer of
Bio-Path Holdings.
The Phase 2 clinical trial is a multi-center, open label study
with two parallel cohorts of BP1001 in combination with decitabine
in untreated AML and high risk MDS patients or refractory/relapsed
AML and high risk MDS patients who are ineligible or unwilling to
receive intensive induction therapy. The primary objective of the
study is to assess whether BP1001 in combination with decitabine
provides higher response rates than decitabine alone in AML or high
risk MDS patients. In addition, a six-patient safety run-in of
BP1001 and decitabine was completed with no dose adjustment
required.
BP1001 is a neutral liposome incorporated with
nuclease-resistant, hydrophobic P-ethoxy antisense
oligodeoxynucleotides targeted to Grb2 mRNA. Grb2 is an adaptor
protein that links oncogenic tyrosine kinases with downstream
kinases, such as ERK and AKT, which are critical to cell
proliferation and survival. Preclinical results showed that BP1001
enhanced the inhibitory effects of cytarabine or decitabine against
AML cells.
The poster also describes future development plans for BP1001 in
AML. Preclinical results suggest that BP1001 plus venetoclax plus
decitabine triple combination could be more efficacious than the
BP1001 + decitabine combination against AML cells. Venetoclax will
be added to the study, thus exploring three-drug combinations of
BP1001, venetoclax and decitabine. There will be three patient
cohorts in the study:
- Untreated AML patients will be treated with BP1001 plus
venetoclax plus decitabine.
- Refractory/relapsed AML patients will be treated with BP1001
plus venetoclax plus decitabine.
- A third cohort of BP1001 + decitabine will be offered to
refractory/relapsed AML patients who are venetoclax resistant or
intolerant, or not considered by the investigator as optimal
candidates for venetoclax-based therapy.
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.
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, BioPath’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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