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Bio-Path Holdings to Present Data at American Society of Clinical Oncology (ASCO) Annual Meeting

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Bio-Path Holdings (NASDAQ: BPTH) announced that it will present interim data from its Phase 2 clinical trial of prexigebersen for Acute Myeloid Leukemia (AML) at the ASCO Annual Meeting from May 31 - June 4, 2024.

The trial, involving prexigebersen combined with decitabine and venetoclax, showed promising results, demonstrating compelling efficacy and good tolerance in newly diagnosed and refractory/relapsed AML patients.

This presentation aims to highlight the potential of prexigebersen within the oncology community and encourage broader clinical participation.

Details of the presentation include: Title - Interim Safety and Efficacy of BP1001 in a Phase II AML Study, Date - June 1, 2024, Time - 8:00 AM CT, Location - McCormick Place, Abstract Number - 6511.

Bio-Path is also advancing other candidates, BP1001-A and BP1002, for various cancers and plans an IND for BP1003 targeting STAT3.

Positive
  • Interim Phase 2 trial data of prexigebersen shows compelling efficacy and good tolerance in AML patients.
  • Selected for prestigious oral presentation at ASCO Annual Meeting, increasing visibility within the oncology community.
  • Presentation may encourage greater participation in prexigebersen studies, potentially accelerating clinical progress.
  • BPTH's lead product candidate, prexigebersen (BP1001), targets the Grb2 protein and is in Phase 2 trials for blood cancers.
  • BPTH is advancing BP1001-A for solid tumors and BP1002 for blood cancers and solid tumors.
  • BPTH plans to file an IND for BP1003, targeting STAT3, indicating pipeline expansion.
Negative
  • The success of prexigebersen is still interim and not yet final, representing potential uncertainty in final outcomes.
  • No specific financial data or revenue projections provided, which could concern investors regarding financial stability.
  • Further clinical trial progress and regulatory approvals are required, indicating potential future hurdles.

Presentation Includes Positive Results from Interim Analysis of Phase 2 Clinical Trial of Prexigebersen in Acute Myeloid Leukemia (AML)

HOUSTON, May 23, 2024 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today announced an upcoming oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 31 - June 4, 2024 in Chicago, IL.

Maro Ohanian, D.O., Department of Leukemia, University of Texas MD Anderson Cancer Center, will present interim results from the Company’s Phase 2 study of prexigebersen (BP1001) in combination with decitabine and venetoclax for the treatment of acute myeloid leukemia (AML). The data show prexigebersen continues to be well-tolerated and has now demonstrated compelling efficacy results in two reporting cohorts including evaluable newly diagnosed AML patients and evaluable refractory/relapsed AML patients, both of which exceeded outcomes with frontline therapy.

“We are honored that our abstract was selected by the ASCO Scientific Program Committee and Leadership for a prestigious oral presentation as part of a Rapid Oral Abstract Session. ASCO is the ideal setting to present these encouraging data, as it is the world's largest clinical cancer research meeting with more than 30,000 oncology professionals in attendance,” said Peter Nielsen, Chief Executive Officer of Bio-Path. “It is important to showcase these important data and expand awareness of prexigebersen within the field as it may encourage greater participation in this and our other prexigebersen studies.”

Details for the oral presentation are as follows:

Title: Interim Safety and Efficacy of BP1001 in a Phase II Acute Myeloid Leukemia Study
Date and Time: Saturday, June 1, 2024 at 8:00 AM CT
Location: McCormick Place
Abstract Number: 6511

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 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’Connor
Stern Investor Relations, Inc.
212-362-1200
will@sternir.com

Doug Morris
Investor Relations
Bio-Path Holdings, Inc.
832-742-1369 


FAQ

What did Bio-Path Holdings announce regarding its Phase 2 trial?

Bio-Path Holdings announced interim results from its Phase 2 clinical trial of prexigebersen for AML, showing efficacy and good tolerance.

When and where will Bio-Path present its Phase 2 trial data?

The presentation will occur at the ASCO Annual Meeting from May 31 - June 4, 2024, in Chicago, IL.

What combination of drugs is being tested in Bio-Path's Phase 2 trial?

The Phase 2 trial is testing prexigebersen in combination with decitabine and venetoclax.

What is the significance of Bio-Path's presentation at ASCO?

The presentation at ASCO increases visibility within the oncology community and may encourage greater participation in Bio-Path's studies.

What are other candidates in Bio-Path's pipeline?

Other candidates include BP1001-A for solid tumors, BP1002 for blood and solid tumors, and BP1003 targeting STAT3.

What are the promising results from Bio-Path's Phase 2 trial?

The promising results include compelling efficacy and good tolerance in newly diagnosed and refractory/relapsed AML patients.

What is Bio-Path's lead product candidate?

Bio-Path's lead product candidate is prexigebersen (BP1001), targeting the Grb2 protein.

Bio-Path Holdings, Inc.

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