Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The FDA has approved a Phase II registration protocol using Epeius Biotechnologies' intravenous Rexin-G for recurrent or metastatic osteosarcoma that is refractory to known therapies.
Subscribe to our email newsletter
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.