Sponsor Overview
Explore verified public information about OS Therapies's expanded access programs, compassionate use policies, and patient eligibility pathways. This report aggregates official statements, independent research, and regulatory data to help patients, providers, and sponsors collaborate efficiently.
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Expanded Access Intelligence
Official Statements
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“OS Therapies is committed to delivering new, innovative immunotherapies to oncology patients by conducting rigorous clinical trials and obtaining market approval by the FDA and other regulatory authorities. In line with this commitment, we support expanded access programs when we have substantial scientific evidence to support the safety and efficacy for our therapies when it is logistically possible. Expanded access programs offer a lifeline to patients who have exhausted other treatment options and are ineligible for ongoing clinical studies, or patients involved in our clinical studies who seek continued treatment after the study has been completed.”
Reagan-Udall Foundation Insights
Single-Patient EA Policies/Criteria Patient eligibility criteria: - Suffer from pulmonary-recurrent osteosarcoma that has been completely resected; - Have undergone appropriate standard treatments without success and no comparable treatment is available/exists to treat the disease; - Are ineligible for participation in any ongoing clinical study of OST31-164 (including lack of access due to geographical constraints); - The projected benefit of the patient’s treatment outweighs the known or anticipated risks; - There is adequate information to support dosing for the individual patient. Additionally, OS Therapies will consider the following when making a determination about delivery of OST31-164 under this policy: - There is adequate supply of OST31-164 available; - Making OST31-164 available will not negatively impact or delay the conduct of clinical trials, regulatory reviews, or approval of OST31-164 for broader patient access; - The requesting physician is properly licensed and must agree to comply with: - Any applicable country specific legal and regulatory requirements related to providing an investigational product under expanded access; - Any OS Therapies requirements in terms of medical criteria, safety reporting, drug supply/use and protection of intellectual property. A treating physician may submit questions or requests regarding expanded access to OS Therapies Chief Medical and Scientific Officer, Dr. Robert Petit ( rp@ostherapies.com ). It is important to note that the Expanded Access Program of OST31-164 will be discontinued if any of the below criteria are met: - OST31-164 becomes commercially available and is therefore more broadly accessible to these patients; - A negative regulatory decision or OS Therapies decision to discontinue development of OST31-164; - New information becomes available about the activity or safety of OST31-164 that could substantially alter the benefit/risk profile for patients; - Limited supply of OST31-164 or manufacturing issues. Available Therapies via Single-Patient EA OST31-164 - for the treatment of pulmonary-recurrent pediatric osteosarcoma after resection
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