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Data From a New Study on DiagnoCure (CUR)'s GCC Assay Show Positive Results for Predicting Risk of Colon Cancer Recurrence


6/3/2013 11:10:30 AM

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PrevistageTM GCC colorectal cancer test featured at the 2013 ASCO Annual Meeting

QUEBEC CITY, June 3, 2013 /PRNewswire/ - DiagnoCure Inc. (TSX: CUR) (OTCQX: DGCRF) today reported that results of a new study were presented on Sunday, June 2, during the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago, Illinois. The abstract of the presentation entitled "Guanylyl cyclase C (GCC) expression in lymph nodes (LNs) as a determinant of recurrence in stage II colon cancer (CC) patients (pts)" (Abstract #3639), by Dr. Daniel J. Sargent, Professor of Biostatistics and Oncology at Mayo Clinic, and colleagues, is now available on the American Society of Clinical Oncology's website, www.asco.org.

"We believe this new study provides very strong evidence that measuring the expression level of GCC in lymph nodes is central to improved staging for patients diagnosed with node-negative colon cancer." said Dr Yves Fradet, President and Chief Medical Officer of DiagnoCure. "Prognostic risk stratification in stage II colon cancer remains a very clinically important issue and the ability of our PrevistageTM GCC test to predict recurrence independently of traditional histopathology risk factors should have significant clinical impact for physicians treating colon cancer and their patients."

The VITAR retrospective study (Validating Indicators To Associate Recurrence) had been designed to assess the relationship between GCC gene expression in formalin fixed (FFPE) LNs and time to recurrence (TTR) in stage II Colon Cancer patients not treated with adjuvant chemotherapy. The second phase (called VITAR II), the results of which were presented at the 2013 ASCO meeting, focused on the positive lymph node ratio (LNR), defined as the number of nodes in which cancer cells were identified with the GCC assay, divided by the total number of nodes examined to provide recurrence risk stratification. On a validation set including 463 untreated stage II (T3N0) colon cancer patients from North American and European sites, the study showed that molecular staging based on GCC LNR status was able to predict higher recurrence risk for 195 patients (42%) treated by surgery alone. All patients had not been treated with adjuvant chemotherapy mainly because their lymph nodes appeared cancer-free by examination under the microscope, yet 10% of them had a disease recurrence or died from cancer afterwards.

Outcome associations were also strengthened when considering a 3-level GCC categorization. In the final study cohort (n=366), the PrevistageTM GCC test classified 21.8% of patients as having a high risk of recurrence following surgery, 17.5% at intermediate risk and 60.7% of patients at low risk of recurrence. In this subset analysis, the 5-year recurrence risk was estimated at 8% and 22% for the low and high risk groups respectively, with a hazard ratio of 2.7 (p=0.006) supporting the prognostic capabilities of the GCC nodal status as an independent risk factor.

These findings complement those obtained during the first phase of the prospectively specified multi-center VITAR study performed on 241 stage II CC patients which were published in 2011 (Sargent, Annals Surg Onc 2011).

About Colorectal Cancer and PrevistageTM GCC

Every year in the United States and Canada, 165,000 people are diagnosed with colorectal cancer. Of that number, 69,000 are considered at low risk after surgery. Nonetheless, up to 20% of them suffer recurrence of a more advanced cancer. To date, results of published studies totaling over 1,000 patients have shown that, compared with traditionally-used factors, the GCC biomarker is a better predictor of disease recurrence in earlystage colorectal cancer patients. PrevistageTM GCC is currently the only colorectal cancer staging test that provides prognostic information based on the tumor burden measured at the molecular level in the lymph nodes. Tumor burden in the lymph nodes has become more widely recognized by treating physicians as a key prognostic factor to determine the risk of recurrence of cancer patients, and hence, to determine which patients might benefit most from adjuvant chemotherapy and which could be safely managed without chemotherapy.

About DiagnoCure

DiagnoCure (TSX: CUR; OTCQX: DGCRF) is a life sciences corporation that develops and commercializes high-value cancer diagnostic tests that increase clinician and patient confidence in making critical treatment decisions. In 2008, the Corporation launched a colorectal cancer staging test through its U.S. CLIA laboratory. PrevistageTM GCC is currently available for licensing. The Corporation has granted a worldwide exclusive license to Gen-Probe, now a wholly-owned subsidiary of Hologic Inc. operating as Hologic Gen-Probe, for the development and commercialization of a prostate cancer test using PCA3, DiagnoCure's proprietary molecular biomarker. Hologic Gen-Probe's PROGENSA® PCA3 test is commercialized in Europe under CE mark and is approved for commercialization in Canada and the United States. For more information, please visit www.diagnocure.com.

Forwardlooking statements

This release may contain forwardlooking statements that involve known and unknown risks, uncertainties and assumptions that may cause actual results to differ materially from those expected. Forward-looking statements can be identified by the use of the conditional or forward-looking terminology such as "anticipates", "assumes", "believes", "estimates", "expects", "intend", "may", "plans", "projects", "should", "will", or the negative thereof or other variations thereon. Forward-looking statements also include any other statements that do not refer to historical facts. All such forward-looking statements are made pursuant to the "safe-harbour" provisions of applicable Canadian securities laws. By their very nature, forwardlooking statements are based on expectations and hypotheses and also involve risks and uncertainties, known and unknown, many of which are beyond DiagnoCure's control. Forward-looking statements are presented for the purpose of assisting investors and others in understanding certain key elements of the Corporation's current objectives, strategic priorities, expectations and plans, and in obtaining a better understanding of the Corporation's business and anticipated operating environment. Readers are cautioned that such information may not be appropriate for other purposes and that they should not place undue reliance on these forwardlooking statements. For instance, any forward-looking statements regarding the outcome of research and development projects, clinical studies and future revenues, including those related to PROGENSA® PCA3, are based on management expectations and such outcome may vary materially depending on global political and economic conditions, dependence on collaboration partners, uncertainty of healthcare reimbursement, and marketing and distribution challenges. In addition, the reader is referred to the applicable general risks and uncertainties described in DiagnoCure's most recent Annual Information Form under the heading "Risk Factors". DiagnoCure undertakes no obligation to publicly update or revise any forwardlooking statements contained herein unless required by the applicable securities laws and regulations.


SOURCE DiagnoCure inc.



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