Lixte Biotechnology Holdings, Inc. (NASDAQ: LIXT) announced that it will double enrollment in its ovarian clear cell carcinoma trial from 21 to 42 patients by adding a second site at Northwestern University’s Robert H. Lurie Comprehensive Cancer Center. The expansion, which brings the total planned enrollment to 42, is intended to strengthen the statistical power of safety and efficacy analyses for the company’s first‑in‑class PP2A inhibitor, LB‑100.
The trial will be led by Dr. Amir Jazaeri, the company’s principal investigator, and Dr. Emily M. Hinchcliff, the new site’s principal investigator. Lixte expects to present data from the initial 21 patients in the first half of 2026, with results from the expanded cohort to follow later in the year. The company’s timeline reflects a deliberate effort to accelerate data collection and to position LB‑100 for potential regulatory discussions and partnership opportunities.
From a strategic perspective, the enrollment increase is a key step in validating LB‑100’s ability to enhance chemotherapies and immunotherapies in a rare ovarian cancer subtype. By expanding the patient base, Lixte aims to generate more robust evidence that could support future approvals and attract additional collaborators. The move also signals confidence in the trial’s design and the company’s ability to manage a larger, multi‑site study, which may improve investor perception of execution capability.
Financially, Lixte reported a Q3 2025 net loss of $1.98 million and $2.89 million in cash. The company recently raised $4.3 million through a registered direct offering to support ongoing clinical development. GSK’s financial commitments remain tied to the original cohort size, while MD Anderson will conduct the expanded study at its own cost in exchange for milestone payments and royalties. These arrangements illustrate the company’s approach to balancing external funding with partnership incentives.
Management emphasized the clinical significance of the expansion. Chief Scientific Officer Bas van der Baan said, “We are gratified to be expanding the patient population of this important clinical trial. There is a tremendous unmet need in the treatment of ovarian clear cell cancer, and we believe LB‑100 has the potential to significantly enhance chemotherapies and immunotherapies.” Chief Executive Officer Geordan Pursglove added, “Expansion of this important trial is in keeping with Lixte’s mission of treating cancer with innovative therapies and cutting‑edge technologies.” Investors have noted the company’s focus on scientific validation, while also remaining cautious about dilution from the recent capital raise.
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