Oncoceutics, Inc. announced the successful completion of the dose escalation phase of a clinical trial for the company’s lead molecule ONC201 using weekly dosing. Oncoceutics has previously reported the exceptional safety profile for ONC201 in multiple clinical trials using a dosing regimen of once every three weeks.
The weekly cohort was part of a trial entitled “Oral ONC201 in Treating Patients With Advanced Solid Tumors,” at Rutgers Cancer Institute of New Jersey, identified as NCT02250781 on www.clinicaltrials.gov.
The decision to pursue an intensified dose regimen of weekly administration was driven by the excellent safety profile demonstrated by ONC201 in this Phase I trial and subsequent expansion with a focus on those tumor types that showed signs of tumor engagement in Phase I. The protocol was then amended to enroll additional patients with advanced solid tumors in a dose intensified regimen utilizing weekly dosing. Patients were dosed with ONC201 at 375mg/week or 625mg/week, the previously established RP2D using every three week dosing. Oncoceutics is pleased to report that the safety profile with weekly administration was similar to that observed with the once every three week dose.
In addition to the weekly dose intensification program underway at Rutgers Cancer Institute of New Jersey, Oncoceutics is currently conducting three other clinical trials with weekly dosing, including a trial in advanced myeloid leukemias at the University of Texas MD Anderson Cancer Center, a trial in non-Hodgkin’s lymphomas, also at the University of Texas MD Anderson Cancer Center, and a trial at the Fox Chase Cancer Center.
“ONC201 continues to demonstrate an exceptional safety profile,” said Mark Stein, MD, medical oncologist at Rutgers Cancer Institute of New Jersey, and principal investigator of the study. “The excellent safety profile of ONC201 allowed us to pursue this dose intensification, and I look forward to continuing to treat patients with this new schedule.”
“ONC201 has an exciting therapeutic profile with its unusual safety, sustained biological activity, and novel mechanism of action,” said Bryce Istvan, Business Development and Finance Associate for Oncoceutics. “We are pleased to see the drug’s safety profile remains intact at weekly dosing.”
Oncoceutics, Inc. is a clinical-stage drug discovery and development company with a novel class compounds that selectively target G protein-coupled receptors for oncology. The first lead compound to result from this program is ONC201, an orally active DRD2 small molecule antagonist that is well-tolerated and effective against advanced cancers. The company recently completed a successful Phase I study in solid tumors and has begun additional Phase I/II and Phase II clinical programs in both solid and hematological malignancies. Oncoceutics and collaborative groups have received more than $7 million in grants over the last two years, including grants from the National Cancer Institute, the U.S. Food and Drug Administration, the Pennsylvania Department of Health, and The Musella Foundation. In addition, outside interest in the 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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