Philadelphia, PA (May 7, 2019) – Oncoceutics announced that the US Food and Drug Administration invited the company to present information regarding its lead compound ONC201 at the public advisory committee meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee on June 20, 2019.
The meeting will provide Oncoceutics with the opportunity to present its clinical data for patients treated with ONC201, including studies for both adult and pediatric patients with gliomas containing the H3 K27M mutation, a disease that has been recognized to be an area of high unmet medical need. Additionally, the meeting will enable Oncoceutics to receive feedback from the subcommittee on issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of ONC201 for pediatric use.
“We are honored and grateful for the opportunity to present to the Pediatric Oncology Subcommittee of the ODAC,” said Wolfgang Oster, MD, PhD, Chief Executive Officer and Chairman of Oncoceutics. “ONC201 has shown biological activity that we hope will translate into the clinic and eventually make a difference in patients’ lives. We look forward to furthering the clinical development of ONC201 with the support and guidance of the FDA.”
The Public Advisory Committee Meeting will take place in the Great Room of the FDA’s White Oak campus from 8am to 4:30pm. Oncoceutics will present at 12:30pm. Background materials will be available at least 2 business days before the meeting at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm, and interested persons from the public may present data, information, or views, orally or in writing, on issues pending before the subcommittee.
Oncoceutics, Inc. is a clinical-stage drug discovery and development company with a novel class of compounds, called “imipridones,” that selectively target G protein-coupled receptors for oncology. The first lead compound to emerge from this program is ONC201, an orally active small molecule DRD2 antagonist. The company is supported by grants from NCI, FDA, Musella Foundation, XCures, Cancer Commons, and a series of private and public partnerships. Visit Oncoceutics or contact Press@oncoceutics.com for more information.