Shares of OS Therapies Incorporated (NYSE: OSTX) experienced a significant rise following the completion of patient enrolment in its AOST-2121 clinical trial. As of the latest trading session, OSTX stock surged by 11.06%, reaching $3.25.
Final Evaluations and FDA Engagement
Today, OS Therapies (OSTX) announced that the final patient, designated as Patient #41, has successfully completed their final radiographical evaluation after 52 weeks of participation in the AOST-2121 clinical trial, which investigates the efficacy of OST-HER2 in treating recurred and resected Osteosarcoma.
With the conclusion of the treatment period, the company is now poised to engage with the U.S. Food & Drug Administration (FDA). OS Therapies plans to request a Type C Meeting to discuss potential protocol adjustments based on the FDA’s recommendations.
Following these modifications, the company will proceed to lock the clinical trial database in preparation for data analysis, with topline results expected to be announced in the fourth quarter of 2024.
Company Visibility and Leadership Engagement
In a related announcement, OS Therapies will ring the closing bell at the New York Stock Exchange today. Additionally, Paul Romness, President and CEO of OSTX, is set to participate in two live interviews on prominent national television networks, including “B” Block in Market Movers on Fintech.TV and Trading 360 on the Schwab Network, both of which will be aired today.
Novel Therapeutic Strategy for the Treatment of Osteosarcoma
The goal of the OST-HER2 biologic therapy candidate is to improve overall survival rates for patients with osteosarcoma by preventing metastasis, delaying recurrence, and acting as a Lm (Listeria monocytogenes) vector-based immunotherapeutic vaccination.
The AOST-2121 Phase 2b clinical trial, involving 41 participants across 21 clinical sites in the United States, targets individuals with a history of recurrent metastatic disease to the lungs. Patients received 16 doses of OST-HER2 at three-week intervals, with follow-up assessments occurring after the final dose, culminating in a comprehensive 52-week study.
The anticipated topline data will include Event Free Survival (EFS) and interim Overall Survival (OS) statistics, contributing to the ongoing exploration of treatment options for this challenging condition.