Data presented at ASCO meeting supports the benefits of Immunomedics' colorectal diagnostic imaging product in pre-surgical patient evaluation; Data submitted to FDA in support of licensing application.MORRIS PLAINS, N.J.--(Health Wire)--May 23, 1995--Immunomedics Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : IMMU IMMU Independent Munitions Maintenance Unit ) today announced that its colorectal diagnostic imaging product, CEA-Scan(TM), has been shown to provide surgical oncologists with diagnostic information that is clinically useful in the pre-surgical evaluation of recurrent colorectal cancer colorectal cancer Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat. patients. The data were presented today at the American Society of Clinical Oncologists meeting in Los Angeles. These clinical results were derived from the Phase III study performed for CEA-Scan(TM) and were prepared in response to the FDA's request to demonstrate a clinical setting for use of CEA-Scan (TM). Data regarding the clinical utility of CEA-Scan(TM) in determining patient resectability were submitted to the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. in early March 1995. In a study involving 208 assessable patients who had the results of computed tomography Computed tomography (CT scan) X rays are aimed at slices of the body (by rotating equipment) and results are assembled with a computer to give a three-dimensional picture of a structure. (CT) and CEA-Scan(TM) correlated with surgery, CEA-Scan(TM) alone demonstrated 60 percent accuracy in predicting tumor resectability in patients with known or suspected recurrent colorectal cancer, as compared to 47 percent for CT alone. When CT and CEA-Scan(TM) indicated differing assessments of resectability, CEA-Scan(TM) was correct more often than CT (69 percent vs. 31 percent, respectively). When both imaging procedures indicated that the patient is not resectable re·sect·a·ble adj. Suitable for resection. , the accuracy of that prediction is 94 percent, potentially alleviating the need for additional diagnostic procedures. "This study suggests that CEA-Scan(TM) is a valuable tool in determining resectability in colorectal patients," said Kevin Hughes, Surgical Oncologist, Lahey Clinic. "CEA-Scan(TM) has the potential to improve the cost-benefit ratio Cost-benefit ratio The net present value of an investment divided by the investment's initial cost. Also called the profitability index. of surgical treatment of colorectal patients by providing more accurate preoperative pre·op·er·a·tive adj. Preceding a surgical operation. preoperative preceding an operation. preoperative care the preparation of a patient before operation. information helping to ensure that surgery will be performed only for patients most likely to benefit from the surgical procedure." Immunomedics is a biopharmaceutical company applying innovative technology in antibody selection, modification and chemistry to the development of products for the detection and treatment of cancer and infectious diseases. Integral to these products are highly specific monoclonal antibodies designed to deliver radioisotopes and chemotherapeutic agents to tumors and sites of infectious or other diseases. The company's colorectal cancer imaging agent, CEA-Scan(TM), is under review for marketing approval by the U.S. Food and Drug Administration, as well as by regulatory agencies in Europe and Canada. In addition, Immunomedics currently has a therapeutic product and several other diagnostic imaging products in clinical trials. CONTACT: Immunomedics Inc. Amy Factor, 201/605-8200 |
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