Oncoceutics Release: Clinical Trial For ONC201 Begins At Fox Chase Cancer Center
Philadelphia (November 30, 2015) – Oncoceutics, Inc. announced that enrollment of patients with various solid tumors as well as multiple myeloma has commenced for a clinical study of the company’s novel first-in-class lead compound, ONC201, at Fox Chase Cancer Center (FCCC). The study is designed as a dose escalation study that explores the administration of ONC201 on a weekly basis in addition to the once every three-week schedule that was used in the recently completed first Phase I study. The FCCC study, identified as NCT02609230 on www.clinicaltrials.gov, will be led by Anthony Olszanski, MD, Director of the Phase I Experimental Therapeutics Program at FCCC.
This clinical trial builds on the experience of the completed Phase I study and related extension phase at the Rutgers Cancer Institute of New Jersey that confirmed the compelling safety profile of ONC201. Data from this study was recently presented at the 2016 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (available here). This trial is evaluating the safety, pharmacokinetics and pharmacodynamics of ONC201 in types of cancer that were not evaluable in the completed Phase I study. This study will also allow patients to receive a longer duration of therapy using different dose frequencies.
ONC201 exhibits a remarkably benign safety profile at doses conferring blood concentrations that exceed therapeutic thresholds in preclinical settings. This safety profile encourages more frequent and prolonged dosing to potentially optimize the efficacy of the drug. Recent data generated in the laboratory Wafik El-Deiry, MD, PhD, FACP, Professor of Oncology at Fox Chase Cancer Center and Scientific Founder of Oncoceutics, suggest that such intensified exposure can have a significant effect on metastatic spread and overall response of highly refractory tumors.
“This clinical study is part of a larger collaborative effort between Oncoceutics and FCCC that has added significant momentum and value to the translational research effort between both teams,” said Wolfgang Oster, MD PhD, CEO, Chairman and co-founder of Oncoceutics. “We greatly appreciate that ONC201’s unique features have garnered the interest of leading cancer centers that support an unusually broad development program to exploit the many therapeutic opportunities of the drug.”
“We are delighted to open this clinical program at FCCC that has the opportunity to demonstrate the drug’s usefulness in multiple indications,” said Lee Schalop, MD, Chief Business Officer and co-founder of Oncoceutics. “The study positions ONC201 as a novel therapeutic with significantly more flexibility on administration schedules than offered by other drugs with toxic side effects, inconvenient administration requirements and resistance against therapy. In contrast, ONC201 offers excellent tolerability, oral bioavailability and effectiveness in preclinical settings against resistance mechanisms.”
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.
Visit Oncoceutics or contact Carinna Gano for more information.
This clinical trial builds on the experience of the completed Phase I study and related extension phase at the Rutgers Cancer Institute of New Jersey that confirmed the compelling safety profile of ONC201. Data from this study was recently presented at the 2016 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (available here). This trial is evaluating the safety, pharmacokinetics and pharmacodynamics of ONC201 in types of cancer that were not evaluable in the completed Phase I study. This study will also allow patients to receive a longer duration of therapy using different dose frequencies.
ONC201 exhibits a remarkably benign safety profile at doses conferring blood concentrations that exceed therapeutic thresholds in preclinical settings. This safety profile encourages more frequent and prolonged dosing to potentially optimize the efficacy of the drug. Recent data generated in the laboratory Wafik El-Deiry, MD, PhD, FACP, Professor of Oncology at Fox Chase Cancer Center and Scientific Founder of Oncoceutics, suggest that such intensified exposure can have a significant effect on metastatic spread and overall response of highly refractory tumors.
“This clinical study is part of a larger collaborative effort between Oncoceutics and FCCC that has added significant momentum and value to the translational research effort between both teams,” said Wolfgang Oster, MD PhD, CEO, Chairman and co-founder of Oncoceutics. “We greatly appreciate that ONC201’s unique features have garnered the interest of leading cancer centers that support an unusually broad development program to exploit the many therapeutic opportunities of the drug.”
“We are delighted to open this clinical program at FCCC that has the opportunity to demonstrate the drug’s usefulness in multiple indications,” said Lee Schalop, MD, Chief Business Officer and co-founder of Oncoceutics. “The study positions ONC201 as a novel therapeutic with significantly more flexibility on administration schedules than offered by other drugs with toxic side effects, inconvenient administration requirements and resistance against therapy. In contrast, ONC201 offers excellent tolerability, oral bioavailability and effectiveness in preclinical settings against resistance mechanisms.”
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.
Visit Oncoceutics or contact Carinna Gano for more information.