LIXTE Biotechnology and the Spanish Sarcoma Group Enroll First Patient in a Phase 1b/2 Randomized Trial of Doxorubicin +/- LIXTE’s Lead Anti-Cancer Compound, LB-100, in Advanced Soft Tissue Sarcomas
PASADENA, CA, June 07, 2023 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT) (“LIXTE”), a clinical-stage drug discovery company developing pharmacologically active drugs for use in cancer treatment, today announced the enrollment of the first patient in the Phase 1b portion of the Phase 1b/2 protocol (NCT05809830) to determine the appropriate dose of LB-100 given with a standard dose of doxorubicin. Once the dose is determined, a randomized Phase 2 study will be initiated seeking to gain evidence that the inclusion of doxorubicin increases time to a progression and/or overall survival of patients with advanced soft tissue sarcomas (ASTS).
John S. Kovach, MD, LIXTE’s founder and Chief Executive Officer, commented, “The Phase 1b portion of the clinical trial to determine the recommended phase 2 dose (RP2D) is expected to be completed within approximately nine months from commencement. Subsequently, up to ten more clinical sites are expected to join the international Phase 2 portion of the study to enter up to 150 patients, randomized to standard cytotoxic chemotherapy with doxorubicin alone, versus doxorubicin plus LB-100. Given the lack of effective first-line treatments for ASTS, this trial has been designed to provide data expected to be sufficient to justify proceeding to a Phase 3 comparative study.”
Dr. Javier Martin-Broto, sarcoma expert at the Fundación Jiménez Díaz University Hospital, Madrid, Spain, the principal investigator of the clinical trial, commented, “This clinical trial offers innovative research in the sarcoma field aiming to explore in the clinic a combination of doxorubicin and LB-100, an inhibitor of PP2A, which has proved to be synergistic in the preclinical setting. The Phase 1b part is starting now, while deep investigations are being developed to search the most robust predictive biomarkers for LB-100 activity in the sarcoma context. Investigators of this trial are excited and hopeful, with the idea of potentially improving the efficacy exhibited by doxorubicin alone during its solo 40-year reign. We have 3 activated sites in Spain right now and 3 additional sites will join the Phase 1b part in the coming weeks.”
About LIXTE Biotechnology Holdings, Inc.
LIXTE Biotechnology Holdings, Inc. is a clinical-stage pharmaceutical company focused on new targets for cancer drug development and developing and commercializing cancer therapies. LIXTE has achieved a breakthrough demonstrating that its first-in-class lead clinical PP2A inhibitor, LB-100, is well-tolerated in cancer patients at doses associated with anti-cancer activity. Based on extensive published preclinical data (see www.lixte.com), LB-100 has the potential to significantly improve outcomes for patients undergoing various chemotherapies or immunotherapies. LIXTE's new approach has no known competitors and is covered by a comprehensive patent portfolio. Initial proof-of-concept clinical trials are in progress.
About GEIS (Grupo Español de Investigación en Sarcomas)
GEIS is a non-profit organization in Spain engaged in the research, development and management of studies and clinical trials for sarcomas. GEIS has a mission to ensure the best healthcare to sarcoma patients by helping bring new treatments to them through clinical research. GEIS has successfully partnered with various institutions and companies to help bring new treatments to patients with sarcomas. Through the group’s many research projects it has created or participated in over the years, it has made a significant impact in the global research effort to better treat patients with sarcomas. For more information: http://www.grupogeis.org.
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Released June 7, 2023