Hummelstown, PA – Oncoceutics announced that it has been awarded the second part of a Fast-Track Small Business Innovation Research (SBIR) award from the National Cancer Institute (NCI) to clinically evaluate its lead molecule, ONC201, in advanced brain cancer (glioblastoma multiforme or GBM). The company previously received the first part of the award in March 2015 and successfully completed part one.
Part two of the Fast-Track SBIR award totals $1.4 million over two years (September 2015-August 2017) and will support a phase II clinical trial with single agent ONC201 at the Dana-Farber Cancer Institute. Andrew Chi, MD, PhD, Assistant Professor of Neurology / Neuro-Oncology, will lead the study, which will enroll 30 patients with advanced GBM who have been treated previously with first-line therapy of radiation and temozolomide.
ONC201 is a first-in-class, orally active, small molecule that penetrates the blood brain barrier and exhibits strong anticancer activity in aggressive preclinical models of GBM. The company recently completed the first-in-man study of ONC201 at the Rutgers Cancer Institute of New Jersey and defined the recommended phase 2 dose (RP2D) that will be used in this trial and for subsequent clinical studies.
“We are delighted to receive this grant award from the NCI to advance the clinical development of ONC201 in GBM, which is one of the lead indications for this product,” said Wolfgang Oster, MD, PhD, Chief Executive Officer of Oncoceutics and the Principal Investigator of the award. “The SBIR award is an important indication of the significant clinical and commercial opportunity of ONC201. We are extremely grateful to the NCI for its continued support of ONC201 as we execute our development of this unique therapy.”
About Oncoceutics
Oncoceutics, Inc. is a clinical-stage drug discovery and development company targeting the most potent suppressor pathways in human cancer. The first lead compound to result from this program is ONC201, a small molecule drug with a unique mechanism of action that causes significant anti-tumor activity in a variety of types of human cancer. The Company is currently enrolling patients in clinical trials of ONC201 that began in January 2015, following acceptance by the U.S. Food and Drug Administration of the Company’s Investigational New Drug (IND) application for ONC201 in 2014. Oncoceutics and collaborative groups have received more than $5 million in grants over the last two years from the National Institutes of Health, the Pennsylvania Department of Health, and The Musella Foundation, and the company has leveraged additional funding from academic medical research partners that support multiple Phase I/II Clinical trials.
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