Philadelphia, PA (November 2, 2015) – Oncoceutics, Inc. announced that the results of the first-in-human dose escalation study of its lead compound, ONC201, will be presented at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference in Boston on Sunday, November 8. The results from the clinical study, which is being conducted at the Rutgers Cancer Institute of New Jersey, will be presented by Mark Stein, MD, principal investigator of the clinical trial and medical oncologist at Rutgers. The presentation (abstract #C137) will take place from 12:30-3:30pm in the session entitled “New Molecular Targets”, located in Exhibit Hall C-D.
The phase I dose escalation study that will be presented used an accelerated dose escalation design with one patient per dose level using rigorous safety criteria that allowed subsequent dose escalation only when there were no adverse events greater than Grade 1. As expected, based on the excellent preclinical safety profile of ONC201, the study advanced through all five intended dose levels, i.e. from 125 mg through 625 mg, with only one patient per dose level. At the highest dose level of 625 mg, six patients were enrolled. In addition, the study identified a recommended Phase II dose with excellent safety, PK levels in the therapeutic range, evidence of tumor engagement and prolonged PD.
“We are delighted that our lead compound exceeded our expectations in terms of predictable performance on safety, PK and early evidence of tumor engagement,” said Martin Stogniew, PhD, Chief Development Officer of Oncoceutics.
Meetings with Dr. Stein can be arranged for interested Individuals. Please contact Rohinton Tarapore.
Oncoceutics, Inc. is a clinical-stage drug discovery and development company targeting potent suppressor pathways in human cancer. The first lead compound that entered clinical development from this program is ONC201, a small molecule with an active angular structure and a unique mechanism of action that causes significant anti-tumor activity in a variety of human cancers. The company recently completed a successful Phase I study in solid tumors and has begun clinical Phase II programs in both solid and hematological malignancies. Oncoceutics has been awarded several competitive grants for its development programs with ONC201 and its other candidates in this new class of compounds. In addition, outside interest in company’s portfolio has resulted in several R&D alliance agreements between Oncoceutics and leading comprehensive cancer centers, including The University of Texas MD Anderson Cancer Center and the Fox Chase Cancer Center. The Company has established a robust Intellectual property position, including several issued patents.
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