TUSTIN, CA--(Marketwire - March 08, 2011) - In response to 'TheStreet.com' news article published earlier this week regarding Radient Pharmaceuticals Corporation (RPC) (NYSE Amex: RPC), RPC confirmed today its post-launch trial "Evaluation of AMDL-ELISA DR-70" (RPC's Onko-Sure® in vitro diagnostic cancer test) is on track.
This project is designed to further validate the efficiency of Onko-Sure® relative to the Carcinoembryonic Antigen (CEA) marker in colorectal cancer patients. Specifically, RPC's study compares the effectiveness of RPC's Onko-Sure® IVD cancer test to the CEA marker in a large population of patients (N=976), including non-cancer patients (normal) and patients in stages I through IV (Dukes A through D) with colorectal cancer. A single study using serum samples from a large population of colorectal patients has never been conducted, and it is anticipated this study will further clarify the efficacy of Onko-Sure® compared to CEA, and/or, in comparison to potentially combining these two markers. The study has market significance because of the large number of early stage colorectal cancer patients globally that can potentially benefit from a diagnostic test offering an effective tumor marker for early detection of a recurrence of colorectal cancer.
As part of a collaboration agreement with Mayo Validation Support Services (MVSS), MVSS provided RPC with 976 biospecimens and annotation that were tested by Mayo with the standard CEA cancer screening test. Radient completed the testing of the biospecimens using its Onko-Sure® IVD cancer screening test on March 4, 2011 and will submit the data from its Onko-Sure® tests, along with the CEA tests performed on the same samples by MVSS, to a third party statistical analysis service for sample decoding. The final study results will be part of RPC's clinical post-launch validation of Onko-Sure®. Under the agreement, the final RPC study data and corresponding results will be returned to MVSS.
The FDA-cleared Onko-Sure® in July 2008 and it has been independently validated by six different peer-reviewed studies with results published in various scientific journals. In 2010 alone, there have been two post-launch validation studies published on Onko-Sure®. The following is the link to the FDA website for RPC's Onko-Sure® clearance.
TheStreet.com article implied that MVSS was not involved with the study or any clinical study with RPC based upon Mayo samples. Mayo's spokesperson Kathy Anderson stated correctly that all services required by MVSS under the agreement with RPC have been fulfilled. MVSS provided these services in exchange for pre-determined fees, which were paid in full in February 2011.
For additional information on Radient Pharmaceuticals Corporation and its products visit: www.radient-pharma.com or send e-mail to info@radient-pharma.com. For Investor Relations contact Kristine Szarkowitz at IR@RadientPharma.com or 1.206.310.5323.
About Radient Pharmaceuticals:
Headquartered in Tustin, California, Radient Pharmaceuticals is dedicated to saving lives and money for patients and global healthcare systems through the deployment of its FDA-cleared In Vitro Diagnostic Onko-Sure® Test Kits for colon-rectal cancer recurrence monitoring. The company's focus is on the discovery, development and commercialization of unique high-value diagnostic tests that help physicians answer important clinical questions related to early disease-state detection, treatment strategy, and the monitoring of disease progression or recurrence. To learn more about our company, products, and potentially life-saving cancer test, visit www.radient-pharma.com.
About Mayo Validation Support Services
Mayo Validation Support Services, an affiliate of Mayo Clinic, assists pharmaceutical, biotechnology and diagnostic companies in testing emerging biomarkers and technologies. Mayo's contribution of well-annotated biospecimens and clinical follow-up data support the development of individualized medicine, one of Mayo's strategic initiatives.
www.mayovalidation.com
Forward-Looking Statements:
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: The statements contained in this document include certain predictions and projections that may be considered forward-looking statements under securities law. These statements involve a number of important risks and uncertainties that could cause actual results to differ materially including, but not limited to, the performance of joint venture partners, as well as other economic, competitive and technological factors involving the Company's operations, markets, services, products, and prices. With respect to Radient Pharmaceuticals Corporation, except for the historical information contained herein, the matters discussed in this document are forward-looking statements involving risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements.
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