Lixte Biotechnology Holdings, Inc. has announced an expansion of its collaboration with The University of Texas MD Anderson Cancer Center and pharmaceutical manufacturer GSK on an ongoing clinical trial evaluating its proprietary compound LB-100 in combination with GSK's Dostarlimab for the treatment of ovarian clear cell cancer. The trial, initiated in January 2024 and led by Amir Jazaeri, MD, at MD Anderson, has added a second site at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University under the direction of Emily M. Hinchcliff, MD, MPH, and is expected to double enrollment to 42 patients following completion of its initial 21-patient target.
This expansion represents a significant step forward in addressing ovarian clear cell carcinoma, a particularly aggressive subtype of ovarian cancer that often shows resistance to conventional chemotherapy. The company expects data from the initial cohort to be presented in the first half of 2026, providing crucial insights into the potential of this novel combination therapy. LIXTE's lead compound, LB-100, is part of a pioneering effort in an entirely new field of cancer biology called activation lethality, which represents an emerging treatment paradigm.
The importance of this trial expansion lies in its potential to accelerate development of new treatment options for patients with limited therapeutic alternatives. Ovarian clear cell cancer accounts for approximately 5-25% of ovarian cancers in Western countries and has been associated with poorer outcomes compared to other ovarian cancer subtypes. By doubling the patient enrollment through the addition of Northwestern University as a second site, researchers can gather more comprehensive data on safety and efficacy, potentially leading to more robust clinical findings.
According to the company's published preclinical data available at https://www.lixte.com, LB-100 has demonstrated potential to significantly enhance chemotherapies and immunotherapies and improve outcomes for cancer patients. The compound represents a first-in-class PP2A inhibitor that has shown to be well-tolerated in cancer patients at doses associated with anti-cancer activity. This expansion follows proof-of-concept clinical trials currently in progress for both Ovarian Clear Cell Carcinoma and Metastatic Colon Cancer.
The implications of this expanded trial extend beyond the immediate patient population to the broader oncology field. Successful results could validate LIXTE's novel approach to cancer treatment and potentially lead to new combination therapies for various cancer types. The collaboration between a biotechnology company, a leading academic cancer center, and a major pharmaceutical manufacturer represents the type of partnership necessary to advance innovative cancer treatments through the clinical development pipeline.
Additional information about LIXTE can be found at https://lixte.com/. The company maintains a comprehensive patent portfolio covering its new approach to cancer treatment, positioning it to potentially bring novel therapies to market if clinical trials prove successful. This expansion demonstrates continued confidence in the scientific rationale behind combining LB-100 with immunotherapy agents like Dostarlimab for difficult-to-treat cancers.
