Philadelphia (December 14, 2015) – Oncoceutics, Inc. announced that patient enrollment has commenced for a clinical trial in acute leukemias at the University of Texas MD Anderson Cancer Center (MDACC) of the company’s lead compound, ONC201. The trial, identified as NCT02392572 on www.clinicaltrials.gov, is entitled “Phase I/II Study of Oral ONC201 in Patients with Relapsed/Refractory Acute Leukemias and High-Risk Myelodysplastic Syndromes.”
The Phase I/II trial will investigate the use of ONC201 in patients with relapsed or refractory acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS). Gautam Borthakur, MD, an Associate Professor in the Department of Leukemia at MDACC, is the Principal Investigator for the trial.
Extensive preclinical studies conducted at MDACC have demonstrated a high level of efficacy in both in vitro and in vivo models against acute leukemias, with an almost complete depletion of leukemic stem cells and no significant side effects, including no genotoxic effects. 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 promising addition to currently available therapies, according to Oncoceutics.
“ONC201 is a unique new chemical entity that has recently been introduced into clinical testing,” said Dr. Borthakur. “MDACC is pleased to have the exclusive rights to study this drug in hematological malignancies, including acute leukemias and MDS. We are committed to building our arsenal of drugs to combat hematologic cancers, and we are hopeful that the compelling preclinical activity of ONC201 in leukemias translates into clinical usefulness.”
Wolfgang Oster, MD PhD, CEO, Chairman and co-founder of Oncoceutics, added, “We are pleased with the activation of this important clinical study under the strategic alliance and research collaboration agreement between Oncoceutics and MD Anderson for the clinical development of ONC201 in both non-Hodgkin’s lymphomas and acute leukemias. We appreciate the significant resources MD Anderson will devote to these two clinical trials, and we’re confident that ONC201’s novel mechanism of action will offer a new therapy for patients who have exhausted their treatment options.”
About Oncoceutics
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.
The Phase I/II trial will investigate the use of ONC201 in patients with relapsed or refractory acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS). Gautam Borthakur, MD, an Associate Professor in the Department of Leukemia at MDACC, is the Principal Investigator for the trial.
Extensive preclinical studies conducted at MDACC have demonstrated a high level of efficacy in both in vitro and in vivo models against acute leukemias, with an almost complete depletion of leukemic stem cells and no significant side effects, including no genotoxic effects. 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 promising addition to currently available therapies, according to Oncoceutics.
“ONC201 is a unique new chemical entity that has recently been introduced into clinical testing,” said Dr. Borthakur. “MDACC is pleased to have the exclusive rights to study this drug in hematological malignancies, including acute leukemias and MDS. We are committed to building our arsenal of drugs to combat hematologic cancers, and we are hopeful that the compelling preclinical activity of ONC201 in leukemias translates into clinical usefulness.”
Wolfgang Oster, MD PhD, CEO, Chairman and co-founder of Oncoceutics, added, “We are pleased with the activation of this important clinical study under the strategic alliance and research collaboration agreement between Oncoceutics and MD Anderson for the clinical development of ONC201 in both non-Hodgkin’s lymphomas and acute leukemias. We appreciate the significant resources MD Anderson will devote to these two clinical trials, and we’re confident that ONC201’s novel mechanism of action will offer a new therapy for patients who have exhausted their treatment options.”
About Oncoceutics
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.
