Philadelphia, PA (December 20, 2016) – Oncoceutics announced that it will expand the ongoing study with ONC201 in recurrent glioblastoma at Massachusetts General Hospital (MGH) and Dana Farber Cancer Institute (DFCI) that is supported by a National Cancer Institute grant awarded to Oncoceutics.
Between January and April, MGH and DFCI enrolled 17 patients with glioblastoma, all of whose tumors had recurred one or more times on the standard of care therapy of radiation and chemotherapy. Based on emerging results from these patients, the trial warrants continuation and is being expanded to allow more patients to potentially benefit. Early results show promising signs of clinical activity, including improvements in disease burden, accompanied by an exceptional safety profile and dosing regimen that causes almost no patient burden. The results of this study will be reported in detail at future scientific forums.
As part of the expansion, the trial will enroll up to 36 additional patients who have had their glioblastoma recur on temozolomide and radiotherapy. Included in this expanded study is a 6 patient cohort who will receive ONC201 before and after surgical removal of their tumor, which will facilitate examination of the mechanism of ONC201 directly in patients’ tumors.
Glioblastoma is one of the most rapidly advancing and deadliest cancers, with only 37% of patients surviving one year from diagnosis and a five-year survival rate of almost zero. No drug has ever been shown prospectively to improve survival once the disease progresses after chemotherapy and radiation. The devastating nature of the disease and the lack of drugs make glioblastoma increasingly recognized as an unmet medical need of paramount importance. Glioblastoma research will be one of the major recipients of government funding from the newly passed 21st Century Cures Act.
“Therapeutic development for brain cancers has stagnated for decades due to the complex nature of these tumors and the drug delivery limitations imposed by the blood-brain-barrier. Glioblastoma possesses a relentless capability to survive despite intense chemotherapy and radiation, which often cause major toxicities. It has become clear that different therapeutic paradigms have to be explored,” said Minesh Mehta, MD, FASTRO, Deputy Director and Chief of Radiation Oncology at Miami Cancer Institute at Baptist Health South Florida and a leading expert on brain and other CNS tumors. “It is gratifying to see the need for innovative therapeutics such as ONC201 being recognized and supported nationally. ONC201’s unique and neuro-oncology relevant target, dopamine receptor D2 (DRD2), and its ability to achieve high concentrations in the CNS make the compound ideally suited for this disease.”
“It is rewarding to be able to offer our patients a treatment that does not impede their quality of life and has the potential to restrain the progression of this deadly disease. We are excited to be able to offer ONC201 to an expanded group of patients to further explore the activity this novel therapy,” said Isabel Arrillaga-Romany, MD, PhD, Associate Clinical Director for Neuro-Oncology at MGH and the Principal Investigator of the study.
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.
Contact Rohinton Tarapore for more information.