Phase I/II Clinical Study of ONC201 Begins in Japan
Philadelphia, PA (April 1, 2020) – Oncoceutics, Inc., announced that it was informed by its Japanese licensee, Ohara Pharmaceutical Co., Ltd., of the initiation of a Phase I/II clinical study of OP-10 (the Japanese name for ONC201) in Japan and the administration of the drug to the first patient.
ONC201 is a novel small molecule with a unique mechanism of action that has demonstrated anti-cancer activity and safety in preclinical models and in several ongoing clinical trials, including clinical trials in adult and pediatric patients with high-grade glioma. In February 2019, Oncoceutics outlicensed rights to ONC201 for Japan to Ohara. Under this strategic partnership, Ohara is responsible for conducting clinical trials required to obtain Marketing Authorization in Japan and the commercialization of ONC201 in the Japanese market.
“We are excited to continue to work with the dedicated team of experts at Ohara as we expand the development of ONC201 to important markets outside the U.S.,” said Lee Schalop, MD, Chief Operating Officer of Oncoceutics. “This clinical trial provides Japanese patients with high-grade glioma immediate access to ONC201, and data from this study will be an important part of working toward a Japanese market approval for ONC201.”
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 lead compound, ONC201, is an orally active small molecule DRD2 antagonist, currently in late Phase II clinical trials for patients with advanced cancers, such as H3 K27M-mutant high-grade glioma. The company is supported by grants from NCI, FDA, The Al Musella Foundation, The Michael Mosier Defeat DIPG Foundation, The Cure Starts Now, and a series of private and public partnerships.
Visit Oncoceutics for more information.
Ohara Pharmaceutical Co., Ltd. is one of the few Japanese pharmaceutical companies that engage in both the orphan drug and generic drug business. Its 3-year “Challenge 2020” business plan commenced in fiscal 2018, with one key objective of this plan being to challenge and address unmet medical needs. The company develops and markets orphan drugs mainly in the field of pediatric oncology and also operates an innovative generic drug business which takes careful consideration to prevent medical accidents. Ohara Pharmaceutical plans to further expand these businesses into emerging countries, primarily in the Asian region.