Immunomedics and FDA planning Medical Imaging Drugs Advisory Committee hearing for CEA-Scan.MORRIS PLAINS, N.J.--(HealthWire)--Nov. 1, 1995--Immunomedics Inc. (Nasdaq: IMMU IMMU Independent Munitions Maintenance Unit ) today announced progress in the regulatory review of its 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. imaging agent, CEA-Scan(TM), by the U.S. Food & Drug Administration (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. ). The company reported that it is working with the FDA to schedule a review, as soon as practicable, of the company's application and clinical data by FDA's Medical Imaging Drugs Advisory Committee (MIDAC MIDAC Michigan Digital Automatic Computer ). The company previously announced that on Oct. 17, 1995 the FDA's Oncologic Drugs Advisory Committee (ODAC ODAC Old Dominion Athletic Conference ODAC Oracle Data Access Components ODAC Oil Depletion Analysis Centre ODAC Oncologic Drugs Advisory Committee ODAC Open Democracy Advice Centre ODAC Open Document Architecture Consortium ODAC Old Dominion Aquatic Club ) deferred a decision on the approvability of CEA-Scan(TM) for recurrent colorectal cancer imaging and recommended that the product may be more suited for review by MIDAC and select oncology consultants. "We are pleased with the cooperative effort on the part of the FDA to facilitate a balanced, well-planned review of our application for CEA-Scan(TM) by MIDAC," said Dr. David M. Goldenberg, chairman of Immunomedics Inc. "The deferment deferment Delaying of an obligation. See Default, Medical student debt. Cf Forbearance. of the decision by ODAC has given the FDA and Immunomedics the opportunity to resolve certain differences in both data and imaging interpretation that were presented during the October 17 meeting. The FDA and Immunomedics want to prepare a cohesive presentation to MIDAC as well as give the Committee members sufficient time to review the materials prior to the hearing," Dr. Goldenberg added. CEA-Scan(TM) is also currently under regulatory review for marketing approval for the same indication in Europe and Canada. As with all regulatory filings, the company cannot predict if or when any approval for marketing CEA-Scan(TM) will be forthcoming. 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. In addition to CEA-Scan(TM), the company's infectious disease imaging agent, LeukoScan(R), is undergoing regulatory review in Europe for imaging osteomyelitis osteomyelitis (ŏs'tēōmī'əlī`tĭs), infection of the bone and bone marrow. Direct infection of bone usually occurs through open fractures, penetrating wounds, or surgical operations. (bone infections). Immunomedics also has several other diagnostic imaging products and a therapeutic product in human clinical trials. CONTACT: Immunomedics Inc., Morris Plains Amy Factor, 201/605-8200 |
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