Oncoceutics, Inc. announced that patient enrollment for a clinical trial of the company’s lead compound ONC201 in non-Hodgkin’s lymphoma has started at The University of Texas MD Anderson Cancer Center (MDACC). The trial, identified as NCT02420795 on www.clinicaltrials.gov, is entitled “Phase I/II Study of Oral ONC201 in Patients with Relapsed/Refractory Non-Hodgkin’s Lymphoma.”
The Phase I/II trial will investigate the use of ONC201 in patients with various non-Hodgkin’s lymphomas, including mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), and transformed large cell lymphoma (TLCL) that have relapsed or are refractory to other therapies. Michael Wang, MD, Professor in the Department of Lymphoma/Myeloma at MD Anderson Cancer Center, is the Principal Investigator for the trial.
“ONC201 is a unique new chemical entity that has demonstrated a high level of efficacy in both in vitro and in vivo models against non-Hodgkin’s lymphoma in extensive preclinical studies conducted at MDACC,” said Dr. Wang. “We are excited to have the exclusive right under our agreement with Oncoceutics to offer this novel compound to our non-Hodgkin’s lymphoma patients in need, and we are hopeful that the compelling preclinical activity of ONC201 in MCL, DLBCL and TLCL translates into clinical usefulness.”
“We are pleased with the initiation of this important clinical program under our unique strategic alliance and research collaboration agreement for the clinical development of ONC201 that was put in place between Oncoceutics and MD Anderson earlier this year,” said Lee Schalop, MD, Chief Business Officer and co-founder of Oncoceutics. “We look forward to a fruitful collaboration under this agreement and continued expansion of our relationship with MD Anderson.”
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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