LOS ALTOS, Calif., March 12, 2019 /PRNewswire/ — xCures and Cancer Commons are pleased to announce a collaboration with Oncoceutics to implement an Expanded Access program for ONC201. Part of this Expanded Access program is an intermediate size Expanded Access protocol for ONC201 in patients with H3 K27M-mutant glioma entitled “ONC018: Expanded Access to ONC201 for Patients with H3 K27M-mutant and/or Midline High Grade Gliomas” that was recently accepted by the U.S. Food and Drug Administration (FDA).
The H3 K27M mutation has been identified as an important prognostic indicator in aggressive midline gliomas that involve specific parts of the brain, including the thalamus, pons, or spinal cord. In 2016, the World Health Organization categorized any midline brain tumor that contains the H3 K27M mutation as the highest grade (IV) because the mutation confers such a poor prognosis. Beyond palliative radiation, no medical therapy has been shown to provide clinical benefit for patients with this mutation in their tumor. Pediatric patients are particularly impacted by this mutation, especially those with DIPG where 70-80% of the patients have the mutation.