Hummelstown, PA (March 31, 2015) – Oncoceutics, Inc. announced that the company was awarded a Small Business Innovation Research (SBIR) grant by the National Cancer Institute (NCI). The combined Phase I/II Fast Track grant will support a clinical trial in ONC201 in advanced brain cancer, furthering the clinical development of the company’s lead compound.
ONC201 is a first-in-class small molecule with consistent antitumor activity in difficult-to-treat cancers. Preclinical research has demonstrated that ONC201 penetrates the blood-brain barrier and is robustly effective in models of glioblastoma multiforme (GBM), the most common and aggressive form of human brain cancer with very limited treatment options.
The Fast-Track SBIR grant is awarded in two parts to support multiple aspects of ONC201 clinical development over a two and a half year period. The first phase of the grant will support the development of formulation and GMP-manufacturing of ONC201. The second phase of the grant will support the evaluation of ONC201 in patients with advanced GBM in a Phase II clinical trial that will be conducted by Dr. Andrew Chi at Massachusetts General Hospital and the Dana-Farber / Harvard Cancer Center.
“ONC201 exhibits a compelling monoagent efficacy profile against several cancers with a particularly strong efficacy profile against GBM,” said Joshua Allen, PhD, VP Development, of Oncoceutics. “Multiple facets of the chemical and biological profile of ONC201 point to GBM as an ideal lead indication for this exciting first-in-class drug.”
“We greatly appreciate the NCI’s support and endorsement as we work with preeminent leaders in GBM research to evaluate the therapeutic potential of ONC201 for this indication, which is in dire need of meaningful treatment options,” commented Martin Stogniew, PhD, Chief Development Officer of Oncoceutics. “The chemical attributes of ONC201 are ideally suited to traverse the blood brain barrier. That dovetails with the powerful effect of the compound that we observed in preclinical testing of ONC201 in GBM.”
Oncoceutics, Inc. is a 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, which 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 approximately $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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