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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
About this update from Lixte Biotechnology Holdings, Inc.
[{"type":"text","content":"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 an...