Based on recent advancements, RPC anticipates it will complete the clinical trial with Mayo in the first quarter of 2011.
The clinical trial represents the largest study conducted to date for RPC's Onko-Sure® IVD cancer test. Approximately 1,000 colorectal patient samples with various disease stages are being tested in parallel by RPC and Mayo to directly compare the efficiency of the Onko-Sure® test with the Carcinoembryonic Antigen (CEA) test. Patients with confirmed clinical diagnoses are tested across six clinically distinct patient groups that include: (1) Stage I colon cancer; (2) Stage II colon cancer; (3) Stage III colon cancer; (4) Stage IV colon cancer; (5) Control subjects who are confirmed negative for colon cancer; and (6) Control subjects with benign polyps of the colon. Many distinct patient groups are included in the trial in order to add multiple layers of data and conclusions to the analyses.
Topline goals of the study include: (1) validation of the overall effectiveness of Onko-Sure® for the detection of colorectal cancer as compared with normal and benign controls; (2) assessing the efficiency of Onko-Sure® in each independent colorectal cancer stage; (3) assessing the overall efficiency of RPC's Onko-Sure® IVD test as compared with that of the CEA test; and (4) comparing the stage-specific efficacy of Onko-Sure® versus CEA; especially early cancer stages. According to industry reports, CEA is reported to misdiagnose a disproportionate number of early stage cancers with 68-97% of biopsy positive patients unable to be monitored with CEA because their CEA values are below the manufacturer's cut-off. Clinical data also confirms detecting cancer in earlier stages can lead to improved accuracy in the treatment, monitoring and recurrence monitoring of the disease in cancer patients.
According to the World Health Organization (WHO) cancer accounts for 7.4 million deaths (around 13 per cent of all deaths) worldwide every year, making it a leading cause of death globally. "We are proud to have reached this important milestone," commented Douglas MacLellan, Chairman and CEO of Radient Pharmaceuticals. "RPC's executive team has been aggressively cultivating relationships across a broad base of oncology and healthcare practitioners and the consistent feedback we've received in regards to the long-term potential of Onko-Sure® test has been overwhelmingly positive. To have internationally recognized leaders in oncology take such great interest in Onko-Sure® is a testament to the importance of the test and we look forward to the long-term and positive impact these relationships and results of the Mayo study can potentially have for cancer physicians and their patients, our Company and shareholders."
RPC's Onko-Sure® IVD cancer test is a simple, non-invasive and regulatory-approved in vitro diagnostic (IVD) test used for the detection and monitoring of the treatment and/or recurrence of various types of cancer. The test enables physicians and healthcare professionals to effectively detect and/or monitor certain types of cancers by measuring the accumulation of Fibrin and Fibrinogen Degradation Products (FDP) in the blood. FDP levels rise dramatically with the progression of cancer. Onko-Sure® is cleared by the US FDA for detection during colorectal cancer treatment and/or for recurrence monitoring in colorectal cancer patients and by Health Canada for the detection, treatment and/or recurrence monitoring of lung cancer.