Philadelphia, PA (March 29, 2017) – Oncoceutics, Inc. announced that Massachusetts General Hospital (MGH) and the Dana Farber Cancer Institute are now enrolling patients in an expansion of the clinical trial “Oral ONC201 in Adult Recurrent Glioblastoma”. The Phase II Trial, identified as NCT02525692 on clinicaltrials.gov, began in early 2016 with recurrent glioblastoma (GBM) patients receiving ONC201 once every three weeks. Following the completion of an interim analysis of this first cohort of patients, the investigators elected to expand enrollment to an additional 36 patients at first recurrence and evaluate the clinical efficacy of ONC201 administered on a weekly schedule.
Results from the first cohort of patients, which will be reported in scientific forums throughout this year, show encouraging signs of clinical activity and a well-tolerated safety profile that has also been observed in other clinical trials with ONC201. In addition to weekly dosing, the expanded clinical trial includes a cohort of patients who will receive ONC201 before and after surgical removal of their tumor, facilitating molecular analyses of tumor specimens and allowing for an examination of the penetrance and mechanism of action of ONC201 directly in patients’ tumors.
The trial is supported by a Small Business Innovation Research (SBIR) grant from the National Cancer Institute of the National Institutes of Health.
In addition to this ongoing clinical trial in glioblastoma, Oncoceutics is evaluating other clinical trial opportunities to study ONC201 in additional neuro-oncology settings, with a focus on patients with specific subtypes of gliomas that may be particularly responsive to ONC201 based on the results of the patients in the first cohort.
“We are excited to begin enrolling patients in the expanded trial of ONC201 in recurrent GBM,” said Isabel Arrillaga-Romany, MD, PhD, Associate Clinical Director for Neuro-Oncology and the Principal Investigator of the study at Massachusetts General Hospital. “Results from the initial cohort of patients confirmed exceptional tolerability of the drug and suggested that it may have clinical activity in recurrent GBM.”
“There are currently no therapies that offer a proven survival benefit to patients with recurrent glioblastoma,” said John de Groot, MD, Chair of Neuro-oncology at MD Anderson Cancer Center. “The clinical results from the first cohort of recurrent glioblastoma patients treated with ONC201 suggest that, like the preclinical results indicated, it may be active in glioblastoma patients. In addition to the response, survival, and pharmacodynamic activities observed, the exceptional safety profile of this novel therapy would be a fantastic opportunity for patients who are ineligible for the limited treatments that we have to offer.”
Oncoceutics, Inc. is a clinical-stage drug discovery and development company with a novel class of 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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