Oncoceutics, Inc. announced that enrollment has been completed in the first-in-man phase I dose escalation study of its lead compound, ONC201. The trial, identified as NCT02250781 on www.clinicaltrials.gov and entitled “Oral ONC201 in Treating Patients with Advanced Solid Tumors,” was carried out at Rutgers Cancer Institute of New Jersey (CINJ) under the leadership of principal investigator Mark Stein, MD.
The study was designed to allow for an increase to the next higher dose with only one patient per dose level based on stringent safety criteria, which required minimal side effects (i.e. no higher than a grade 1 adverse event). As a result of the excellent safety profile of ONC201, the clinical study advanced without delay through all five intended dose levels from 125mg through 625mg; a total of 10 patients were enrolled in the trial – four at the escalating doses and six at the top dose level of 625mg. With the completion of enrollment of the highest dose cohort, the study has defined the recommended Phase II dose (RP2D), which was the primary goal of the trial. The final results of this trial will be reported once full datasets are available for pharmacokinetics, pharmacodynamics, and clinical observations for all enrolled patients.
CINJ will now initiate an efficacy-focused expansion phase into solid tumors with the highest sensitivity to ONC201: prostate; colorectal; and endometrial cancers. Recruitment of patients for this expansion phase will begin shortly.
“I am delighted to see the rapid progress in the clinic with this promising new compound and the realization of several features predicted from preclinical results,” said Keith Flaherty, MD, Director of Developmental Therapeutics, Cancer Center, Massachusetts General Hospital, and a member of the Scientific Advisory Board of Oncoceutics. “It is rare to conclude a first-in-man study with a new cancer drug that exhibits a high degree of safety, reaches therapeutic dose levels in the lowest cohort, and shows early indications of tumor engagement.”
“We are delighted to conclude this clinical Phase I study with an RP2D for ONC201 and results that warrant the further advancement of clinical investigation of our lead molecule,” said Wolfgang Oster, MD, PhD, Chief Executive Officer of 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.
About Cancer Institute of New Jersey (CINJ)
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.
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