Study demonstrates prognostic value of DiagnoCure's Previstage GCC Colorectal Cancer Staging Test

Jan 20 2011

Data to be Presented at the American Society of Clinical Oncology (ASCO) 2011 Gastrointestinal Cancers Symposium by Daniel Sargent, Ph.D., of Mayo Clinic

DiagnoCure Inc. (TSX: CUR), a life sciences company commercializing high‐value cancer diagnostic tests and delivering lab services, today announced positive initial results of a multi-center clinical study of 241 stage II colon cancer patients, a population categorized as low risk by traditional methods yet with an average recurrence rate of 20%.  In this population, the study demonstrated that DiagnoCure's Previstage^TM GCC Colorectal Cancer Staging Test can stratify patients into high and low risk of recurrence groups, thereby providing relevant and more accurate clinical information for physicians to make more personalized treatment decisions.

"Our new study demonstrates the prognostic value of our Previstage^TM GCC assay. In a group of patients currently thought at low risk of recurrence, our test discriminates between those who have a very low risk of recurrence similar to a stage I cancer, and patients who have a higher risk of recurrence similar to a stage III cancer," said Dr Yves Fradet, President and Chief Medical Officer of DiagnoCure.  "We believe that the Previstage^TM GCC test has the potential to significantly improve the treatment decisions by identifying patients whom likelihood of colon cancer recurrence is very low and could be safely managed without chemotherapy."

The first phase of the study, called VITAR (Validating Indicators To Associate Recurrence Risk), included 241 stage II colon cancer patients from six North American clinical sites. All patients had surgery in the prior ten years and had at least three years of follow-up; none received adjuvant chemotherapy.  In a subset of 181 patients with traditionally favorable prognostic factors (T3 tumor and 12 or more lymph nodes examined), the Previstage^TM GCC test classified 1/3 of patients as having a high risk of recurrence following surgery and 2/3 of patients at low risk of recurrence.  In this subset, the high risk group had a 6 times greater likelihood of recurrence than the low risk group (27% versus 4%).

"These results are promising and very relevant.  Prognostic risk stratification in stage II colon cancer remains a very clinically important issue in 2011, as we continue to face the challenge of attempting to identify those patients most likely to benefit from adjuvant chemotherapy," commented Dr. Sharlene Gill, Medical Oncologist at the BC Cancer Agency in Vancouver, also co-investigator of the study.

The initial VITAR study results will be presented by the Principal Investigator, Daniel Sargent, PhD, Professor of Biostatistics and Oncology at Mayo Clinic, at the American Society of Clinical Oncology (ASCO) 2011 Gastrointestinal Cancers Symposium being held on January 20-22 in San Francisco (Abstract #369).  DiagnoCure intends to pursue the second phase of the study to further validate these positive initial results.