SAN FRANCISCO, Jan. 18, 2012 (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 a blood test based on the Company's humanized antibody, clivatuzumab, correctly identified nearly two thirds of patients with early stage pancreatic cancer. 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 2012 Gastrointestinal Cancers Symposium media presscast. The scientific presentation will be given on January 20, 2012.
"Early detection, in addition to better therapeutics, is urgently needed for patients with pancreatic cancer," said Dr. Gold, who developed the first antibody form of clivatuzumab. "Pancreatic cancer symptoms are vague, and the disease tends to develop and grow silently. By the time it is detected, it has often spread to other parts of the body, making it nearly impossible to cure. These study results are extremely encouraging and may eventually lead to improved detection and treatment of the disease in high-risk individuals," he added.
While advances in cancer screening and treatment have prevented more than one million cancer deaths and contributed to the lowering of cancer death rates, according to recent cancer statistics from the American Cancer Society, the lack of early detection and effective treatments for pancreatic cancer have resulted in a dismal 5-year survival rate of only 2% for patients diagnosed with advanced disease, with most patients expected to die within 6 months of diagnosis.?At present, there is no test approved by the U.S. Food and Drug Administration for the detection and diagnosis of pancreatic cancer.
The clivatuzumab-based test examined more than 600 individual blood samples including patients with pancreatic ductal adenocarcinoma (PDAC), which constitutes approximately 90 percent of all pancreatic cancers, and other forms of pancreatic cancer, as well as patients with cancers of the surrounding organs, patients with benign pancreatic disease, such as pancreatitis, and healthy adult volunteers.
Overall, the blood test has a sensitivity of 76% in detecting patients with PDAC.?When combined with CA19-9, another tumor marker commonly tested in blood specimens to monitor pancreatic cancer progression, sensitivity (true-positive rate) improved to 85%, without compromising the true-negative (specificity) rate. Thus, the combination of both assays significantly improved the detection of pancreatic cancer as compared to use of either marker alone. For patients with stage-1, early disease, two-thirds (64%) were accurately identified by the clivatuzumab blood test. The test also detected 50% of patients with extrahepatic biliary and 48% of patients with periampullary adenocarcinomas. Detection of these cancers was not unexpected since these tissues are derived from closely-related organs in early embryonic development.
When tested in tissue specimens, clivatuzumab appears to be able to discriminate PDAC from inflamed pancreatic lesions, but does disclose certain abnormal changes that are considered to be precursors of PDAC (PanINs or pancreatic intraepithelial neoplasias).
"These results demonstrate that reactivity of clivatuzumab is highly restricted to PDAC, with the biomarker present at the earliest stages of neoplastic development," Dr. Gold stated. "To the best of our knowledge, there are no other biomarker or target antigens that are expressed at similarly high frequency and concentration in PDAC, and show such high specificity," Dr. Gold further remarked.
Dr. Gold plans to extend his study to screen for the presence of PDAC at an early stage of tumor growth in individuals who are at high risk for pancreatic cancer, such as patients with chronic pancreatitis, with a history of familial pancreatic cancer, or new-onset diabetes at age over 50.
Commenting on these encouraging results, Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics, said, "In addition to detecting early-stage disease in patients with a high risk of pancreatic cancer, the blood test may also serve as a companion test to monitor patients being treated for this deadly disease."
Leveraging on the specificity for PDAC, the Company is also developing clivatuzumab as a therapy for pancreatic cancer by labeling it with the powerful therapeutic radioisotope, yttrium-90.?Final results from the current Phase Ib/II study will be reported later in the Symposium.?
The Symposium is co-sponsored by the American Gastroenterological Association Institute, the American Society of Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology.
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) methodology 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 189 patents issued 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 for autoimmune indications 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.
CONTACT: Dr. Chau Cheng Director, Investor Relations & Grant Management (973) 605-8200, extension 123 ccheng@immunomedics.com
Source: http://www.globenewswire.com/newsroom/news.html?ref=rss&d=243046
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