WASHINGTON, April 8, 2013 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that the Company's humanized antibody, clivatuzumab, is specifically reactive with pancreatic ductal adenocarcinoma (PDAC) and does not react with chronic pancreatitis (CP) tissues. Dr. David V. Gold, Director of Laboratory Administration and Senior Member of the Garden State Cancer Center in Morris Plains, NJ, presented the study at the 2013 Annual Meeting of the American Association for Cancer Research in Washington, DC. "These data have strong implications for the clivatuzumab-based blood test, suggesting that individuals diagnosed with CP who are found to be positive for this blood test, may in fact have cancer, and should be followed closely for further indications of PDAC," commented Dr. Gold. The clivatuzumab-based blood test has previously been shown to correctly identify nearly two thirds of patients with early stage pancreatic cancer. (For more information, please refer to the Company press release at www.immunomedics.com/pdfs/news/2012/pr01182012.pdf). According to the American Cancer Society, pancreatic cancer is the 10 th most common cancer diagnosis among men and the 9 th most common among women in the U.S. In 2013, an estimated 45,220 new cases will be diagnosed nationwide. The malignancy is one of the deadliest cancer types, accounting for about 7% of all cancer deaths and is the fourth leading cause of cancer death among both men and women. In 2013, approximately 38,460 people are expected to die from pancreatic cancer nationwide. The prognosis of pancreatic cancer is largely determined by the stage of the disease at diagnosis, with median survival ranges from 4.5 months for the most advanced stage to 24.1 months for the earliest stage. However, only about 7% of pancreatic cancer cases are diagnosed at the early stages. It is, therefore, generally recognized that better tests to diagnose pancreatic cancer earlier, before it has metastasized, are needed.
In the current study, 64% of patients with confirmed early-stage disease and 85% with advanced disease were found to have the PAM4-antigen detected by clivatuzumab. Overall specificity was 80% with respect to benign pancreatic disease. Of 120 patients diagnosed with benign conditions of the pancreas, 24 (20%) were positive for the PAM4-antigen, with the majority of these cases being diagnosed with CP (18 of 80 positive or 23%), all of whom had surgical resection performed for severity and/or duration of disease activity.This latter group would at first appear to constitute a rather large number of false positives. However, immunohistochemistry data have shown the PAM4-biomarker is absent from normal pancreas and benign, non-neoplastic lesions of the pancreas. In over 50 surgical specimens of CP, the PAM4-biomarker was identified only within pancreatic intraepithelial neoplasia lesions (precursors to PDAC) that are associated with long-term CP, and not by the inflamed tissue. These results suggest that PAM4-positive CP patients, and likely other PAM4-positive patients diagnosed with benign conditions of the pancreas, may very likely have pancreatic neoplasia (invasive and/or precursor lesions), and therefore should be followed closely. Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics, remarked: "We believe this blood test has the potential to become a companion diagnostic for our clivatuzumab-directed radiation therapy we are developing for pancreatic cancer. The Phase Ib study of yttrium-90-labeled clivatuzumab has completed the enrollment of pancreatic cancer patients with 2 or more prior therapies. Results from this study have been submitted for presentation at an upcoming medical conference." About Immunomedics Immunomedics is a New Jersey-based biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases. We have developed a number of advanced proprietary technologies that allow us to create humanized antibodies that can be used either alone in unlabeled or "naked" form, or conjugated with radioactive isotopes, chemotherapeutics, cytokines or toxins, in each case to create highly targeted agents. Using these technologies, we have built a pipeline of therapeutic product candidates that utilize several different mechanisms of action. We also have a majority ownership in IBC Pharmaceuticals, Inc., which is developing a novel DOCK-AND-LOCK™ (DNL™) method with us for making fusion proteins and multifunctional antibodies, and a new method of delivering imaging and therapeutic agents selectively to disease, especially different solid cancers (colorectal, lung, pancreas, etc.), by proprietary, antibody-based, pretargeting methods. We believe that our portfolio of intellectual property, which includes approximately 220 active patents in the United States and more than 400 foreign patents, protects our product candidates and technologies. For additional information on us, please visit our website at www.immunomedics.com. The information on our website does not, however, form a part of this press release. This release, in addition to historical information, may contain forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements, including statements regarding clinical trials, out-licensing arrangements (including the timing and amount of contingent payments), forecasts of future operating results, potential collaborations, and capital raising activities, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. Factors that could cause such differences include, but are not limited to, risks associated with any cash payment that the Company might receive in connection with a sublicense involving a third party and UCB, which is not within the Company's control, new product development (including clinical trials outcome and regulatory requirements/actions), our dependence on our licensing partners for the further development of epratuzumab and veltuzumab for non-cancer indications, competitive risks to marketed products and availability of required financing and other sources of funds on acceptable terms, if at all, as well as the risks discussed in the Company's filings with the Securities and Exchange Commission. The Company is not under any obligation, and the Company expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.
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