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Bio-Path Holdings Announces Successful Completion of Higher Dose Second Cohort in Phase 1/1b Clinical Trial of BP1002 in Refractory/Relapsed Acute Myeloid Leukemia (AML) Patients
Bio-Path Holdings, Inc. announces the successful completion of the higher dose second cohort in the Phase 1/1b clinical trial of BP1002 for refractory/relapsed Acute Myeloid Leukemia (AML) patients. BP1002 targets the Bcl-2 protein, offering hope for venetoclax-resistant AML patients. The trial aims to evaluate the safety and efficacy of BP1002 in treating patients with treatment options, potentially overcoming resistance mechanisms to venetoclax treatment. The completion of the second dose cohort marks a significant milestone for FDA review, with plans to progress to higher doses and combination therapy segments in the future.
Bio-Path Holdings, Inc. annuncia il completamento con successo del secondo gruppo a dosaggio più elevato nello studio clinico di Fase 1/1b di BP1002 per pazienti con Leucemia Mieloide Acuta (AML) refrattaria o recidivante. BP1002 prende di mira la proteina Bcl-2, offrendo speranza ai pazienti con AML resistenti al venetoclax. Lo studio mira a valutare la sicurezza e l'efficacia di BP1002 nel trattamento di pazienti con opzioni terapeutiche limitate, superando potenzialmente i meccanismi di resistenza al trattamento con venetoclax. Il completamento del secondo gruppo di dosaggio rappresenta una pietra miliare significativa per la revisione da parte della FDA, con piani di procedere a dosaggi più elevati e segmenti di terapia combinata in futuro.
Bio-Path Holdings, Inc. anuncia la finalización exitosa del segundo grupo de dosis más alta en el ensayo clínico de Fase 1/1b de BP1002 para pacientes con Leucemia Mieloide Aguda (AML) refractaria o recaída. BP1002 se dirige a la proteína Bcl-2, ofreciendo esperanza para los pacientes con AML resistentes al venetoclax. El ensayo tiene como objetivo evaluar la seguridad y eficacia de BP1002 en el tratamiento de pacientes con opciones terapéuticas limitadas, superando potencialmente los mecanismos de resistencia al tratamiento con venetoclax. La finalización del segundo grupo de dosis marca un hito significativo para la revisión de la FDA, con planes de avanzar a dosis más altas y segmentos de terapia combinada en el futuro.
Bio-Path Holdings, Inc.는 BP1002를 이용한 1/1b상 임상 시험에서 더 높은 용량의 두 번째 코호트를 성공적으로 완료했다고 발표했습니다. 이 임상 시험은 반응하지 않거나 재발한 급성 골수성 백혈병(AML) 환자를 대상으로 합니다. BP1002는 Bcl-2 단백질을 목표로 하여 베네토클락스에 저항하는 AML 환자에게 희망을 제공합니다. 이 시험은 치료 옵션이 제한된 환자들을 대상으로 BP1002의 안전성과 효능을 평가하는 것을 목표로 하며, 베네토클락스 치료에 대한 저항성 메커니즘을 극복할 가능성을 탐색합니다. 두 번째 용량 코호트의 완료는 FDA 검토를 위한 중요한 이정표로, 앞으로 더 높은 용량과 병용 요법 세그먼트로 진행할 계획입니다.
Bio-Path Holdings, Inc. annonce l'achèvement réussi de la deuxième cohorte à dose plus élevée dans l'essai clinique de phase 1/1b de BP1002 pour les patients atteints de Leucémie Myéloïde Aiguë (LMA) réfractaire ou récidivante. BP1002 cible la protéine Bcl-2, offrant espoir aux patients atteints de LMA résistants au vénétoclax. L'essai vise à évaluer la sécurité et l'efficacité de BP1002 dans le traitement des patients disposant d'options thérapeutiques limitées, en surmontant potentiellement les mécanismes de résistance au traitement par vénétoclax. La réalisation de la deuxième cohorte de dose constitue une étape importante pour l'examen par la FDA, avec des plans pour progresser vers des doses plus élevées et des segments de thérapie combinée à l'avenir.
Bio-Path Holdings, Inc. gibt den erfolgreichen Abschluss der zweiten Kohorte mit höherer Dosis in der klinischen Phase-1/1b-Studie von BP1002 für Patienten mit refraktärer/ rezidivierender Akuter Myeloischer Leukämie (AML) bekannt. BP1002 zielt auf das Bcl-2-Protein ab und bietet Hoffnung für Patienten mit Venetoclax-resistenter AML. Die Studie zielt darauf ab, die Sicherheit und Wirksamkeit von BP1002 bei der Behandlung von Patienten mit begrenzten Behandlungsoptionen zu bewerten, um möglicherweise Widerstandsmechanismen gegen Venetoclax-Behandlungen zu überwinden. Der Abschluss der zweiten Dosis-Kohorte markiert einen bedeutenden Meilenstein für die Überprüfung durch die FDA, mit Plänen, in Zukunft zu höheren Dosen und Kombinationstherapie-Segmenten fortzuschreiten.
Positive
Successful completion of the higher dose second cohort in the Phase 1/1b clinical trial of BP1002 for refractory/relapsed AML patients.
BP1002 targets the Bcl-2 protein, offering hope for venetoclax-resistant AML patients.
Potential to overcome resistance mechanisms to venetoclax treatment.
Significant milestone achieved for FDA review with plans for higher doses and combination therapy segments.
Published preclinical studies show BP1002 as a potent Bcl-2 inhibitor with a benign safety profile.
Phase 1/1b trial conducted at leading cancer centers in the United States.
National Principal Investigator for the trial is Gail J. Roboz, M.D.
Negative
None.
Insights
The successful completion of the second cohort in a Phase 1/1b clinical trial points to a promising development for patients with refractory or relapsed AML, particularly those resistant to venetoclax. BP1002's mechanism, targeting mRNA to inhibit the Bcl-2 protein, shows potential in addressing the resistance observed in current treatments. The data from this trial segment is critical for understanding the safety and dosage efficacy before proceeding to combination therapy trials. As this is only an early-stage trial, long-term efficacy and safety are yet to be determined. Nevertheless, this milestone could be an early indicator of the drug's potential, which may influence the company's stock in terms of investor expectations for future growth.
AML is a challenging cancer to treat and resistance to standard treatments like venetoclax is a significant hurdle in patient care. Bio-Path's BP1002 provides a novel approach by targeting the Bcl-2 at the mRNA level. If the drug demonstrates efficacy in higher doses without increasing toxicity, it would represent a significant advancement in treating these high-risk patients. From a clinical perspective, the future phases of this trial, particularly the combination with decitabine, will be closely watched to assess not just efficacy but also any potential synergistic effects that could enhance treatment outcomes.
Bio-Path’s announcement is a pivotal development for its clinical pipeline and could potentially lead to increased investor confidence. The progression to higher dose cohorts without safety concerns is a positive sign and the FDA's pending review adds a layer of validation to the process. Investors should note, however, that the biotechnology sector is volatile and investment in such companies carries significant risk due to the binary nature of clinical trial outcomes. If Bio-Path continues to report positive data, it could lead to an uptick in its stock value, but it's essential to balance optimism with the inherent risks of clinical development.
BP1002 Offers Unique Opportunity for Venetoclax-Resistant AML Patients Utilizing RNAi to Limit AML Cell’s Ability to Produce Cancer Enabling Bcl-2 Protein
HOUSTON, April 18, 2024 (GLOBE NEWSWIRE) -- 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 completion of the second dose cohort of the dose escalation portion of its Phase 1/1b clinical trial of BP1002 evaluating the ability of BP1002 to treat refractory/relapsed acute myeloid leukemia (AML) patients, including venetoclax-resistant patients.
“We are delighted to safely progress through the second, higher dose cohort to reach an important study milestone for the United States Food and Drug Administration (FDA) to review patient study data,” said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. “Enrollment rates have been good, and we look forward to advancing this study in even higher doses with the hope that we can sooner reach the combination therapy segment of our Phase 1/1b study with increased levels of BP1002 for the treatment of these vulnerable patients with few, if any, treatment options.”
BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. The current standard of care for patients with AML not eligible for intensive chemotherapy is venetoclax, an oral Bcl-2 inhibitor that targets the BH3 domain of the Bcl-2 protein, in combination with a hypomethylating agent or with low-dose cytarabine. However, many patients become resistant to venetoclax treatment. A published study found that AML patients who had relapsed from frontline venetoclax-based treatment were refractory to salvage therapy and had a median survival of less than 3 months. By targeting Bcl-2 at the mRNA level rather than the protein, BP1002 may overcome and prevent some of the mechanisms of resistance that affect venetoclax treatment. Published preclinical Bio-Path studies have shown BP1002 to be a potent inhibitor against the Bcl-2 target, and we believe that its benign safety profile should enable effective BP1002 combination therapy with approved agents, such as decitabine.
The Phase 1/1b clinical trial is being conducted at several leading cancer centers in the United States, including the Weill Medical College of Cornell University, The University of Texas MD Anderson Cancer Center, Scripps Health, and The University of California at Los Angeles Cancer Center. Initially, the dose escalation portion of the clinical plan calls for a total of six evaluable patients to be treated with BP1002 monotherapy over two dose levels in a standard 3+3 design, with a starting dose of 20 mg/m2 and the second dose of 40 mg/m2. The testing of these two dose levels is now complete and the clinical trial will pause for a brief data review by the FDA, and then we expect that dose testing will continue at the next planned higher dose of 60 mg/m2. The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over twenty-eight days. The Phase 1b portion of the study is expected to commence after completion of BP1002 monotherapy cohorts and will assess the safety and efficacy of BP1002 in combination with decitabine in refractory/relapsed AML patients.
Gail J. Roboz, M.D., is the National Principal Investigator for the Phase 1/1b trial. Dr. Roboz is a professor of medicine and director of the Clinical and Translational Leukemia Program at the Weill Medical College of Cornell University and the New York-Presbyterian Hospital in New York City. Gary Schiller, M.D., The University of California at Los Angeles Cancer Center, Maro Ohanian, D.O., Department of Leukemia, University of Texas MD Anderson Cancer Center, and David Hermel, M.D., Scripps Health, are each serving as principal investigators.
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.
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 212-362-1200 will@sternir.com
Doug Morris Investor Relations Bio-Path Holdings, Inc. 832-742-1369
FAQ
What is the purpose of the Phase 1/1b clinical trial announced by Bio-Path Holdings, Inc.?
The Phase 1/1b clinical trial aims to evaluate the safety and efficacy of BP1002 in treating refractory/relapsed Acute Myeloid Leukemia (AML) patients, including those resistant to venetoclax.
What is the target of BP1002 in the clinical trial?
BP1002 targets the Bcl-2 protein, which is responsible for driving cell survival in up to 60% of all cancers.
Where is the Phase 1/1b clinical trial being conducted?
The trial is being conducted at leading cancer centers in the United States, including Weill Medical College of Cornell University, The University of Texas MD Anderson Cancer Center, Scripps Health, and The University of California at Los Angeles Cancer Center.
Who is the National Principal Investigator for the Phase 1/1b trial?
Gail J. Roboz, M.D., is the National Principal Investigator for the Phase 1/1b trial. She is a professor of medicine and director of the Clinical and Translational Leukemia Program at Weill Medical College of Cornell University and New York-Presbyterian Hospital.
What are the next steps after completing the second dose cohort in the Phase 1/1b clinical trial?
The trial will pause for a brief data review by the FDA, and then dose testing is expected to continue at the next planned higher dose of 60 mg/m2.
