This study will allow brain tumor patients to participate. We funded some of the preclinical work on this. Great to see it move into human trials!
Enrollment Begins In Expansion Phase of ONC201 Clinical Trial
Hummelstown, PA (August 25, 2015) – Oncoceutics, Inc. announced that the first patients have been enrolled in the expansion phase of the first-in-man clinical trial with ONC201 at the Rutgers Cancer Institute of New Jersey (CINJ). Previously, Oncoceutics reported the completion of the dose escalation portion of the trial entitled “Oral ONC201 in Treating Patients With Advanced Solid Tumors” and identified as NCT02250781 on www.clinicaltrials.gov.
During this expansion phase, ONC201 will be administered at an oral dose of 625mg every three weeks, which is the recommended phase II dose (RP2D) as determined in the dose escalation portion of the trial. This study will confirm the safety and pharmacokinetic profiles of ONC201 in patients with advanced solid tumors and will also assess surrogate as well as clinical efficacy endpoints and biomarkers. Mark Stein, MD, a medical oncologist and member of the Phase I/Investigational Therapeutics Program at CINJ, who led the dose escalation portion of the trial, continues as principal investigator.
“We are thrilled with CINJ’s quick transition into the expansion phase with ONC201 following the encouraging results of the first-in-man study,” said Lee Schalop, MD, Chief Business Officer of Oncoceutics. “We expect a number of additional clinical studies to commence enrollment in the near future as we move Oncoceutics towards a broadly-positioned Phase II program.”
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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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