Hummelstown, PA (May 26, 2015) – Oncoceutics, Inc. announced that details of a clinical phase I study in advanced solid tumors of its lead compound, ONC201, will be presented at the annual conference of the American Society of Clinical Oncology (ASCO) in Chicago on Saturday, May 30. The clinical study is being conducted at Rutgers Cancer Institute of New Jersey and will be presented by Mark Stein, MD, principal investigator of the clinical trial and medical oncologist at Rutgers Cancer Institute. The presentation (abstract #TPS2623; poster #328a) will take place from 8 AM until 11:30 AM in the section of “Developmental Therapeutics and Translational Research.”
The phase I dose escalation study that will be presented is designed with one patient per dose level using rigorous safety criteria that allows only Grade < 1 adverse events to permit subsequent dose escalation. As expected, based on the excellent preclinical safety profile of ONC201, the study advanced without delay through all five intended dose levels, i.e. from 125 mg through 625 mg. The wide therapeutic window of the drug also enabled a starting dose that has the ability to reach therapeutic concentrations based on the observed efficacy in preclinical advanced cancer models. Clinical safety, pharmacokinetics, pharmacodynamics and efficacy results are being collected. Once the study is completed, and a recommended phase II dose (RP2D) defined based on the study results, the company will initiate an efficacy-focused expansion phase.
“We are delighted that Rutgers Cancer Institute could serve as the initial site for this ‘first in human’ study of the ONC201 novel agent in oncology,” said Joseph R. Bertino, MD, Chief Scientific Officer and Medical Oncologist at Rutgers Cancer Institute of New Jersey and former President of both ASCO and the American Association for Cancer Research (AACR). “This new compound, ONC201, targets a novel therapeutic space that may allow for further analog development. The drug’s unique chemical structure suggests that it may address a target that has never been drugged before, and recent results indicate that ONC201 may solve many of the impediments we are facing with currently available therapies.”
“As a National Cancer Institute-designated Comprehensive Cancer Center we are the ideal site to conduct early phase clinical trials,” said Robert S. DiPaola, MD, Director of Rutgers Cancer Institute of New Jersey.
The link to the abstract is available here.
About Rutgers Cancer Institute of New Jersey
Rutgers Cancer Institute of New Jersey (www.cinj.org) is the state’s first and only National Cancer Institute-designated Comprehensive Cancer Center. As part of Rutgers, The State University of New Jersey, the Cancer Institute of New Jersey is dedicated to improving the detection, treatment and care of patients with cancer, and to serving as an education resource for cancer prevention. Physician-scientists at the Cancer Institute engage in translational research, transforming their laboratory discoveries into clinical practice, quite literally bringing research to life. The Cancer Institute of New Jersey Network is comprised of hospitals throughout the state and provides the highest quality cancer care and rapid dissemination of important discoveries into the community.
About Oncoceutics
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.
Visit Oncoceutics (www.oncoceutics.com) or contact Carinna Gano (cgano@bridgeny.com) for more information.
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