The approval was based on the exceptional safety profile of Rexin-G in the first 18 patients who participated in the US-based clinical trials, and the profound demonstration of single agent efficacy in metastatic osteosarcoma, according to Epeius.
The adaptive trial design of the Phase II registration protocol incorporates a dosing schedule based on the patient’s estimated tumor burden and not on standard dosing per kilogram body weight or body surface area, and a tumor response evaluation process that is unique to the manner in which osteosarcoma responds favorably to therapy.
Rexin-G is a tumor-targeted gene medicine that seeks out and destroys both primary tumor and metastatic cancers that have spread throughout the body.