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Data Presented Supporting Almac Group Developed Colon Signature As A Significant Predictor Of Risk Of Recurrence In Stage II Colon Cancer


1/28/2014 8:52:59 AM

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CRAIGAVON, UK – January 28, 2014 – Almac’s Diagnostics business unit today announced the presentation of an external validation of their ColDx signature for stage II colon cancer recurrence. Following publication of the initial validation study in the Journal of Clinical Oncology (JCO) in November 2011, Almac subsequently out-licensed the test to Precision Therapeutics, Inc. for further independent validation and commercialisation in the USA.

The study performed by Precision Therapeutics 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 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 utilised 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 the previous independent validation results published in the Journal of Clinical Oncology in 2011 (Kennedy, et al.). The ColDx assay will be marketed by Precision Therapeutics, Inc. 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 personalise 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 personalised 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 Almac Group

‘Partnering to Advance Human Health’

The Almac Group is an established contract development and manufacturing organisation 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 organisation 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 tests.

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.

Visit www.almacgroup.com, e-mail info@almacgroup.com

About Precision Therapeutics

Precision Therapeutics, a leading life-science company based in Pittsburgh, Pennsylvania, is dedicated to personalising 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 personalised medicine products include:

- ChemoFx®, a proprietary drug response marker which categorises 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%.

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