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AACR news: Rigosertib Phase 1 results lead to disease-focused Phase 2 development
Date:4/9/2013

Results of a phase 1 clinical trial reported at the American Association for Cancer Research (AACR) annual conference show that orally administered Rigosertib is well tolerated in patients with advanced solid tumors. This is the first trial in which orally administered Rigosertib, a dual kinase inhibitor, was studied in solid tumors. Intravenously rigosertib is already in phase 3 clinical trials for myelodysplastic syndrome and pancreatic cancer and oral rigosertib is being studied in a pair of Phase II trials in lower-risk transfusion dependent MDS patients. The drug candidate is being developed by Onconova Therapeutics, Inc., of Pennington, NJ.

Overall, 48 patients were included in the Phase I trial with oral rigosertib, and 7 remained on study for at least six months. Six head and neck cancer patients included in this study had failed platinum-based therapies, and 2 of these patients showed a response to Rigosertib one with the disappearance of lung metastasis and another with greater than 50 percent decrease of liver metastasis. These 2 patients have received oral rigosertib treatment for 98 and 48 weeks.

"The results from the head and neck cancer patients are interesting, revealing that the drug worked in a subset of patients," says Antonio Jimeno, MD, PhD, investigator at the University of Colorado Cancer Center and director of the university's Head and Neck Cancer Medical Oncology Program. "To learn more about the relationship between response and genetic make-up of the tumor, we've been investigating molecular correlates in a surrogate Phase 2 trial in patient-derived animal models of head and neck cancer."

As highlighted in the AACR presentation, genetic analysis of tumor samples from the Phase 1 trial and continuing genetic analysis of animal models, performed at both the Colorado Molecular Correlates Laboratory (CMOCO) and Dr. Jimeno's research laboratory, detected several potential biomarkers, including the genes PIK3C
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Contact: Garth Sundem
garth.sundem@ucdenver.edu
805-559-2023
University of Colorado Denver
Source:Eurekalert

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