Investing.com -- Shares of OS Therapies, Inc. (NYSE-A: OSTX) surged 58% following the announcement of positive results from its Phase 2b clinical trial for OST-HER2, an immunotherapy candidate targeting the prevention of recurrent lung metastatic osteosarcoma.
The New York-based clinical-stage biotechnology company reported that the trial met its primary endpoint with statistical significance, demonstrating a 12-month Event Free Survival (EFS) rate of 33.3% for patients treated with OST-HER2, compared to 20% for the historical control group (p= 0.0158). This significant improvement in EFS, which measures the time after treatment during which the patient has no signs of cancer recurrence, suggests a promising development for patients with this rare disease, for which there are currently no approved treatments.
Additionally, interim analyses of the secondary endpoint, 3-year overall survival (OS), indicated a favorable trend for OST-HER2-treated patients at the 1-year and 2-year marks. Notably, 100% of patients who reached the 12-month EFS milestone are still alive. The safety profile of OST-HER2 was also deemed strong, as the treatment was well tolerated during the study.
The company's Chief Medical (TASE:PMCN) & Scientific Officer, Dr. Robert Petit, expressed satisfaction with the trial outcomes, highlighting the statistically significant increase in the likelihood of 1-year and 2-year survival compared to historical controls. OS Therapies' Chair & CEO, Paul Romness, emphasized the success of the primary endpoint achievement, stating the company's intention to pursue an accelerated approval pathway with the U.S. FDA for OST-HER2.
The Phase 2b study involved 39 evaluable patients across 21 centers, with a single treatment arm. Patients aged 12-39 years old with recurred, fully resected lung metastatic osteosarcoma were enrolled and received the investigational treatment. The trial's design included 52 weeks of study, with patients receiving 16 doses every three weeks for 48 weeks, followed by a 4-week final visit.
The news of the trial's success has clearly resonated with investors, propelling OSTX shares upward as the market responds to the potential of OST-HER2 to become the first approved therapy for this challenging indication. The company's announcement underscores its commitment to addressing the unmet medical needs of patients with rare cancers and advancing its clinical and regulatory strategy.
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