PITTSBURGH--(BUSINESS WIRE)--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.”
About GeneFx® Colon
GeneFx Colon is a microarray-based gene signature developed for FFPE tissue from stage II colon cancer patients. GeneFx Colon is performed on a small amount of tissue, removed during surgery and identifies patients at higher risk of recurrence within 5 years following initial surgery. GeneFx Colon is expected to provide better-informed and more personalized treatment decisions for the physicians and patients facing this disease.
About The Alliance for Clinical Trials in Oncology
The Alliance for Clinical Trials in Oncology is a national clinical trials network sponsored by the National Cancer Institute that consists of a network of nearly 10,000 cancer specialists at hospitals, medical centers, and community sites across the country and Canada. The Alliance is dedicated to developing and conducting clinical trials with promising new cancer therapies, and utilizes the best science to develop optimal treatment and prevention strategies for cancer, as well as researching methods to alleviate side effects of cancer and cancer treatments. To learn more about the Alliance, visit http://www.allianceforclinicaltrialsinoncology.org/.
About Precision Therapeutics
Precision Therapeutics, a leading life-science company based in Pittsburgh, Pennsylvania, is dedicated to personalizing cancer care and improving patient outcomes. Precision offers a portfolio of products developed to help guide physicians with difficult clinical decisions throughout the cancer care continuum.
In addition to GeneFx Colon, Precision’s leading personalized medicine products include:
- ChemoFx®, a proprietary drug response marker which categorizes an individual patient’s tumor response to a range of standard chemotherapeutic options. Recently published data demonstrates a 14-month improvement in overall survival (OS) when recurrent ovarian cancer patients are treated with ‘responsive’ therapies as indicated by ChemoFx®.
- BioSpeciFx®, a portfolio of clinically relevant molecular tests that provide information about drug response and patient prognosis.
- Precision also offers the microRNA-based Rosetta Genomics Cancer Origin Test®, which identifies 42 tumor origins with overall specificity up to 99% and overall sensitivity up to 85%.
About Almac Group
‘Partnering to Advance Human Health’
The Almac Group is an established contract development and manufacturing organization that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately owned organization that has organically grown over 30 years and now employs in excess of 3,300 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with US operations based in Pennsylvania, North Carolina and California.
Almac Diagnostics is a division of Almac Group Ltd focusing on the
discovery, development and delivery of novel prognostic and predictive
Almac Diagnostics has a pipeline of oncology based tests in development in therapeutic areas including breast, colon, ovarian, prostate and lung cancer.
In addition Almac Diagnostics partners with the biopharmaceutical industry supporting the discovery, development and delivery of companion diagnostics.