Oncoceutics, Inc. announced that patient enrollment has commenced for a clinical trial at the Massachusetts General Hospital (MGH) of the company’s lead compound, ONC201, in glioblastoma multiforme (GBM). The trial, identified as NCT02525692 on www.clinicaltrials.gov, is entitled “Oral ONC201 in Adult Recurrent Glioblastoma”.
The Phase II trial will investigate the use of single agent ONC201 in adult patients with glioblastoma who have relapsed or are refractory to other therapies and have not been treated with bevacizumab. Isabel Arrillaga-Romany, MD, PhD, an oncologist in the Department of Neurology at MGH, is the Principal Investigator for the trial, under the guidance of Tracy Batchelor, MD, MPH, Director, Division of Neuro-Oncology. The study will also enroll patients at the Dana-Farber Cancer Institute.
Since completing the first-in-man phase I dose escalation study at Rutgers Cancer Institute of New Jersey (CINJ) in July 2015 that established the safety and recommended Phase II dose (RP2D), Oncoceutics has enrolled patients in five additional clinical trials at four of the leading cancer centers in the United States:
|July 2015||Solid Tumors (expansion phase)||Rutgers Cancer Institute of New Jersey|
|Nov 2015||Solid Tumors and Multiple Myeloma||Fox Chase Cancer Center|
|Dec 2015||Non-Hodgkin’s Lymphoma||MD Anderson Cancer Center|
|Dec 2015||Acute Leukemias||MD Anderson Cancer Center|
|Jan 2016||Glioblastoma Multiforme||Massachusetts General Hospital|
These five trials will allow the company to enroll over 200 patients.
“We are extremely pleased to have opened five clinical trials at four of the leading cancer centers in the United States just months after completing our phase I trial,” said Lee Schalop, MD, Chief Business Officer and co-founder of Oncoceutics. “We are indebted to our scientific collaborators and Principal Investigators at these institutions for moving ONC201 so quickly into their clinical programs.”
Wolfgang Oster, MD PhD, CEO, Chairman and co-founder of Oncoceutics, added, “The efficacy and therapeutic index of ONC201, its activity on cancer stem cells and cancer cells that exhibit complex resistance mechanisms, along with a convenient oral intake regimen position this drug as a much needed and promising alternative therapy. Given the positive results from the completed phase I clinical trial and multiple pre-clinical models of challenging tumor types, we are optimistic that ONC201 will offer an opportunity for patients to experience real benefit without toxicity.”
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 first-in-class 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 Phase II clinical 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 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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