New findings validate clinical utility in Colorectal Cancer Staging
MONTREAL, May 16, 2013 /PRNewswire/ - DiagnoCure Inc. (TSX: CUR) (OTCQX: DGCRF) (the "Corporation"), today announced that results from a large validation study of the Previstage TM GCC Colorectal Cancer Staging Test have been selected for presentation at the 2013 American Society of Clinical Oncology ® (ASCO ®) Annual Meeting, taking place in Chicago, Illinois from May 31 to June 4, 2013. The results of the second phase of the VITAR (Validating Indicators To Associate Recurrence Risk) study, which included 463 untreated stage II (T3N0) colon cancer patients from North American and European clinical sites will be presented during this annual meeting. These 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.
The presentation titled "Guanylyl cyclase C (GCC) expression in lymph nodes (LNs) as a determinant of recurrence in stage II colon cancer (CC) patients (pts)" (Abstract #3639), will be exhibited on Sunday, June 2, 8:00 AM - 11:45 AM, S Hall A2.
"Our new study supports the prognostic value of our Previstage TM GCC assay independently of traditional histopathology risk factors. In order to establish a risk of recurrence for the stage II patients, the study focused on the positive LN ratio (LNR), defined as the number of nodes in which cancer cells were identified with the Previstage TM GCC test, divided by the total number of nodes examined," said Dr Yves Fradet, President and Chief Medical Officer of DiagnoCure. "We believe that Previstage TM GCC has the potential to improve management of untreated stage II colon cancer."About Colorectal Cancer and Previstage TM 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 early‐stage colorectal cancer patients. Previstage TM 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. Previstage TM GCC is currently available for licensing. The Corporation has also 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. Forward‐looking statements This release may contain forward‐looking 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", "support", "validate", "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, forward‐looking 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 forward‐looking 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 forward‐looking statements contained herein unless required by the applicable securities laws and regulations.