On April 24, 2023 LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT) ("LIXTE") a clinical-stage drug discovery company developing pharmacologically active drugs for use in cancer treatment, reported that the Spanish Sarcoma Research Group (Grupo Español de Investigación en Sarcomas, or GEIS) completed its first site initiation visit in preparation for the advanced soft tissue sarcoma (ASTS) clinical trial at Fundación Jiménez Díaz University Hospital (Madrid) (Press release, Lixte Biotechnology, APR 24, 2023, View Source [SID1234630479]).
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Fundación Jiménez Díaz University Hospital is the home base of Dr. Javier Martín-Broto, Coordinating Investigator of the clinical trial, GEIS Co-Founder, and an internationally recognized expert in sarcoma research and therapy. Three additional GEIS-associated cancer research centers, located in Valencia, Barcelona, and Madrid, Spain, are expected to be activated in the near-term, with Phase 1b patient accrual planned to begin by mid-May 2023.
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.
John S. Kovach, MD, Founder and CEO of LIXTE, said, "We are very pleased to finally have an opportunity to test whether LB-100 improves the treatment of ASTS. GEIS has been very patient, having had to wait several months for various regulatory approvals to introduce LB-100 into a European clinical trial program. The fact that this trial design is still relevant attests to the slow pace of finding better treatments for this disease."
For a more complete description of the science underlying the study developed by Dr. Martín-Broto and his colleagues, please see:
LIXTE Biotechnology Announces Approval of a Phase 1b/2 Randomized Trial of Doxorubicin +/-Lb-100 in Advanced Soft Tissue Sarcomas to be Conducted by the Spanish Sarcoma Group
The Spanish Sarcoma Group Will Lead a European Consortium to Evaluate the Ability of Lixte Biotechnology Holdings’ LB-100 to Improve First Line Therapy for Advanced Soft Tissue Sarcomas