Data Presented Supporting Precision Therapeutics’ GeneFx® Colon Signature as a Significant Predictor of Risk of Recurrence in Stage II Colon Cancer

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Data Presented Supporting Precision Therapeutics’ GeneFx® Colon Signature as a Significant Predictor of Risk of Recurrence in Stage II Colon Cancer

Precision Therapeutics, a leading life-science company committed to improving the outcomes of cancer patients, announced today the presentation of pivotal data in early-stage colon cancer. The study, performed in conjunction with the Alliance for Clinical Trials in Oncology (Alliance) comprised of investigators from renowned institutions such as Duke University, Dana-Farber Cancer Institute, University of Chicago, Brigham and Women's Hospital, among others, demonstrates that the ColDx assay (Almac Diagnostics, Craigavon, Northern Ireland) is a significant, independent predictor of recurrence-free interval (RFI) in stage II colon cancer. Findings were presented at the 2014 Gastrointestinal Cancers Symposium (ASCO-GI), held January 16-18th, in San Francisco, California.

This large, independent clinical validation study utilized data and samples from 393 stage II colon cancer patients enrolled in the phase III CALGB (Alliance) 9581 clinical trial to assess the ability of the prognostic, 634-probe gene expression signature (ColDx) to improve upon current methods of differentiating patients as higher versus lower risk of recurrence within five years post-surgery. The signature remained significant after adjustment for conventional prognostic risk factors (hazard ratio = 2.1; 95% CI, 1.3-3.4; p < 0.01), including micro-satellite instability (MSI), T-stage and number of nodes examined. These findings confirm previous independent validation results published in the Journal of Clinical Oncology in 2011 (Kennedy, et al.). The ColDx assay has been licensed from Almac Diagnostics to Precision Therapeutics, Inc. and will be marketed under the name GeneFx® Colon in the United States.

“We are delighted that the ColDx assay has, once again, been validated as a prognostic biomarker for early stage colon cancer,” says Richard Kennedy, MD, PhD, McClay Professor in Medical Oncology, Queens University, Belfast and VP and Medical Director, Almac Diagnostics. “We believe this assay has the potential to help clinicians personalize the treatment of this disease and look forward to its full commercial launch this year by Precision Therapeutics.”

Period28 Jan 2014

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  • TitleData Presented Supporting Precision Therapeutics’ GeneFx® Colon Signature as a Significant Predictor of Risk of Recurrence in Stage II Colon Cancer
    Date28/01/2014
    PersonsRichard Kennedy