Hummelstown, PA (March 03, 2015) – Oncoceutics, Inc. is pleased to report that enrollment of the first patient in a clinical trial of ONC201, a novel small molecule anti-cancer drug, is now taking place at Rutgers Cancer Institute of New Jersey. The trial, identified as NCT02250781 on www.clinicaltrials.gov, is entitled “Oral ONC201 in Treating Patients With Advanced Solid Tumors.”
The Phase I trial will investigate the use of ONC201 in patients with solid tumors not amenable to treatment with standard chemotherapy. The trial will be led by Mark Stein, MD, a medical oncologist and member of the Phase I/Investigational Therapeutics Program at the Cancer Institute of New Jersey. Extensive preclinical studies conducted by both Oncoceutics and the Cancer Institute have demonstrated a high level of efficacy in both in vitro and in vivo models against a number of difficult-to-treat solid tumors with minimal side effects. Based on these results, the Cancer Institute has chosen to be the first site to conduct ONC201 clinical studies.
“Our extensive preclinical studies with ONC201 have demonstrated a unique profile for the drug, which acts selectively against cancer cells while sparing normal tissue,” said Dr. Stein, who is also a member of the Eastern Cooperative Oncology Group. “This trial provides us with an opportunity to offer a novel treatment for patients who have exhausted their therapeutic options.”
“As a National Cancer Institute-designated Comprehensive Cancer Center, it is part of our mission to bring novel therapeutics to clinical practice. With that, we are pleased to be the first clinical site to offer ONC201 to patients in need of new therapies,” said Chief Surgical Officer Howard L. Kaufman, MD, FACS, who is also the associate director for clinical science at the Cancer Institute.
“The beginning of our first clinical trial is a major milestone for Oncoceutics and its lead drug candidate ONC201,” said Wolfgang Oster, MD, PhD, CEO of Oncoceutics. “We are grateful to Rutgers Cancer Institute of New Jersey and its leadership team for quickly moving ONC201 into the clinic and are hopeful that ONC201 will offer new therapy options for patients suffering from some of the most difficult to treat cancers.”
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. On February 28, 2014 the U.S. Food and Drug Administration accepted the Company’s Investigational New Drug (IND) application for ONC201. Oncoceutics and collaborative groups have received $4.6 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 an additional $5 million in partnership funding from academic medical research partners.
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