Onconova Therapeutics, Inc. announced two advances in the clinical development of ESTYBON (rigosertib, ON 01910.Na) in presentations at the annual meeting of the American Society of Clinical Oncology (ASCO), June 3-7, 2011, in Chicago, Illinois. Based on the positive trial results presented at the meeting, Onconova also announced the initiation of a Phase II/III study for pancreatic cancer.
“The tolerability of the rigosertib/gemcitabine combination has allowed patients to begin treatment with a full dose of each agent in the proposed randomized Phase II/III trial.”
The first study presented at ASCO highlights the positive results of a Phase I clinical trial in patients with advanced pancreatic cancer and other solid tumors treated with a combination of rigosertib and gemcitabine. This combination will be studied in a new Phase II/III trial. In addition, a second report published by ASCO presents positive results of a Phase I study in solid tumor patients treated with a combination of oxaliplatin and rigosertib.
"This research being presented at ASCO signifies the commitment of Onconova to find novel treatment solutions and improve the lives of patients with cancer," said Robert Maguire, M.D., Distinguished Clinical Fellow for Onconova. "We are excited to present data on the safety, tolerability, and preliminary efficacy of rigosertib with promising results in the treatment of pancreatic cancer and other advanced solid tumors. We are pleased that this study has led to the design and the initiation of the Phase II/III study for pancreatic cancer."
The new clinical trial, designated ONTRAC (ON 01910.Na TRial in Patients with Advanced Pancreatic Cancer), is a Phase II/III, multicenter, randomized, controlled study to compare the efficacy and safety of gemcitabine alone vs. gemcitabine combined with rigosertib (ON 01910.Na) in patients with previously untreated metastatic pancreatic cancer.
The ONTRAC trial represents the most advanced clinical trial to date of rigosertib in combination with chemotherapeutic agents. Previous published non-clinical studies have suggested additive or synergistic activity when various chemotherapeutic agents are used in combination with rigosertib.
"The ability to overcome resistance to chemotherapy, which is commonly encountered in pancreatic cancer, with the addition of a novel agent, would be an important step forward for patients," said Antonio Jimeno, M.D., Ph.D., Associate Professor, University of Colorado Hospital, who has explored combination therapy with rigosertib in pancreatic cancer. "The tolerability of the rigosertib/gemcitabine combination has allowed patients to begin treatment with a full dose of each agent in the proposed randomized Phase II/III trial."
Rigosertib is also being evaluated in a pivotal Phase III trial in myelodysplastic syndrome (MDS), the ONTIME (ON 01910.Na Trial In Myelodysplastic SyndromE) trial. This trial is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Additional information on all Onconova clinical trials is available at www.clinicaltrials.gov.
ASCO presentations on ESTYBON (rigosertib):
"Final results of a phase 1 study of the combination of a novel cell cycle inhibitor ON 01910.Na with gemcitabine in patients with advanced pancreatic and other solid tumors"
Ma WW, Messersmith WA, Dy GK, Freas E, Whitworth A, Wilhelm F, Eckhardt SG, Adjei A, Jimeno A.
Category: Developmental Therapeutics - Experimental Therapeutics
Sub-category: PI3-Akt-mTOR Pathway