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Biotech / Medical : Immunomedics (IMMU) -- Ignore unavailable to you. Want to Upgrade?

To: jluker who wrote (229)	3/20/1998 3:58:00 PM
From: jluker	Respond to of 371

First Commercial In-Vitro Diagnostic Test to Detect and Measure Immune Response in Patients Receiving Mouse Monoclonal Antibody MORRIS PLAINS, N.J., March 20 /PRNewswire/ -- Immunomedics, Inc. (Nasdaq: IMMU) today announced it has received approval from the Center for Devices and Radiological Health branch of the Food and Drug Administration (FDA) to market its ImmuSTRIP(R)-HAMA IgG immunoassay. The ImmuSTRIP-HAMA IgG ELISA test system is intended for the detection and semi-quantitation of human antibodies against mouse protein. Significant serum levels of human anti-mouse antibody (HAMA) have been associated with patients receiving injections of mouse monoclonal antibodies for diagnostic and/or therapeutic purposes. Patients with high HAMA levels may be at risk for anaphylatic or other allergic-type reactions. Circulating levels of HAMA can complex the injected antibody and adversely affect the imaging and/or therapy that was intended. Furthermore, patients developing HAMA can be at serious risk of having aberrant in-vitro laboratory results obtained with mouse monoclonal-based immunoassays. The ImmuSTRIP-HAMA IgG assay is a simple, two-step test performed in about 45 minutes. "We have been using this immunoassay for research purposes to detect and quantitate HAMA levels in patients entered into our clinical trials for imaging and therapy of cancer and infectious diseases. We believe this is an important product for patient safety. Recommended use includes determining baseline HAMA levels prior to the initiation of therapy with mouse monoclonal antibodies and determining HAMA levels at various intervals post-injection," stated Dr. Hansen, V.P. Research and Development at Immunomedics. "Determining which blood samples contain HAMA should also be of value to clinical laboratories measuring test substances in the blood of patients receiving mouse-based products," he added. Immunomedics plans to sell the product through distributors or a corporate partner. Immunomedics is a biopharmaceutical company focused on the development, manufacture and commercialization of diagnostic imaging and therapeutic products for the detection and treatment of cancer and infectious diseases. Integral to these products are highly specific monoclonal antibodies and antibody fragments designed to deliver radioisotopes and chemotherapeutic agents to tumors and sites of infection. The Company's first product, CEA-Scan(R) for the detection of colorectal cancer, has been approved in the United States, Canada, and Europe. The Company's second diagnostic imaging product, LeukoScan(R), has been approved for sale in Europe for the diagnosis of 0steomyelitis (bone infection). This product is presently under regulatory review by the U.S. Food and Drug Administration. Immunomedics also has several other diagnostic imaging products; and two therapeutic products in clinical trials. This news release contains forward-looking statements that involve risk and uncertainties. The development and commercialization of the Company's imaging and therapeutic programs and products may differ materially from the Company's expectations. Among other factors that could result in a materially different outcome are the inherent uncertainties accompanying new product development and marketing, action of regulatory authorities concerning product approval, actions of government and private organizations concerning reimbursement, the impact of competitive products and pricing, and the results of further clinical trials. SOURCE Immunomedics, Inc. /CONTACT: Cynthia Sullivan, Executive Director of Immunomedics, Inc.,973-605-8200 ext. 109/ /Company News On-Call: prnewswire.com or fax, 800-758-5804,ext. 113121/ (IMMU)