Printer Friendly

FDA APPROVES ONCOSCINT AND INDICLOR FOR COLORECTAL AND OVARIAN CANCER DETECTION; FIRST CANCER IMAGING AGENT BASED ON A MONOCLONAL ANTIBODY

 ARLINGTON HEIGHTS, Ill., Dec. 30 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved OncoScint(R) CR/OV, a monoclonal antibody (MAb) product, together with INDICLOR(TM) (indium-111 chloride), a highly purified radio-imaging agent, as a new approach to identifying the location and extent of colorectal and ovarian cancers.
 Colorectal cancer is the second most common malignancy in the world, striking an estimated 150,000 individuals in the United States annually. Ovarian cancer is the leading cause of gynecological cancer death in the United States, with an estimated 21,000 new cases each year.
 The introduction of OncoScint, developed by Cytogen Corporation (NASDAQ-NMS: CYTO), Princeton, N.J., is the first FDA approval of a cancer imaging agent based on in vivo monoclonal antibody techniques. The approval is also the first commercial application of the radio- imaging agent INDICLOR, developed by Amersham International and marketed by Medi-Physics, Inc., Amersham Healthcare, Arlington Heights, Ill., which made the announcement today.
 The two new products work together and consist of a genetically engineered protein or antibody and an innovative imaging agent: the OncoScint CR/OV MAb binds to colorectal and ovarian cancer cells, while the radioactive INDICLOR provides an image of the extent and location of the cancers, detected by specialized gamma cameras.
 Accurate Imaging Crucial to Detection, Treatment
 The prognosis for colorectal and ovarian cancers depends first on the timing and the accuracy of the detection and staging, and secondly on the accuracy and thoroughness of medical and surgical treatment.
 The OncoScint CR/OV-INDICLOR technique offers an easy-to-use, whole body non-invasive yet sensitive imaging technique that, in combination with other appropriate tests, can greatly improve the amount and quality of information available for the diagnosis and treatment of these cancers.
 Although INDICLOR has been used in clinical trials for more than four years, its introduction with OncoScint CR/OV marks the first FDA- approved application of the agent. Additional applications of the imaging agent with other MAb products are currently under FDA review. Furthermore, Cytogen is using its patented and proprietary antibody "linker" technology to develop additional specific cancer diagnostic imaging and cancer therapeutic products.
 Biotechnology Reshaping Medical Patient
 The joint introduction of OncoScint CR/OV and INDICLOR represents not only a new type of product but also a new concept, calling for several pharmaceutical companies and medical specialists to work in concert.
 "The joint approval of OncoScint and INDICLOR underscores the Cytogen and Amersham combined efforts in realizing the potential of biotechnological medicine," said Al Herbert, president, Amersham Healthcare. "It also heralds a new era in medical practice -- an era in which alliances among specialists in surgery, cancer, nuclear medicine and radiology will be enhanced toward optimal care of cancer patients through innovative technology."
 OncoScint CR/OV will be marketed jointly by Cytogen and Knoll Pharmaceutical Company, the U.S. based pharmaceutical operation owned by B.A.S.F., AG and its subsidiary, Knoll, AG, a worldwide pharmaceutical company. INDICLOR is among the diagnostic and therapeutic radiopharmaceutical products marketed by Medi-Physics, Inc., Amersham Healthcare, a leader in growing the fields of nuclear healthcare by providing, through profitable partnerships with customers, innovative products and services which significantly enhance the quality of human life. INDICLOR was developed by Amersham International plc., the U.K. based health science group and a world leader in the supply of advanced products and specialized technologies for use in life science research, healthcare and industrial quality and safety assurance.
 INDICLOR is available to qualified hospitals and other facilities from Medi-Physics, Inc., Amersham Healthcare and MPI Pharmacy Services, Inc., a wholly owned network which provides radiopharmacy services.
 -0- 12/30/92
 /CONTACT: Bill Ehmig, vice president - professional affairs of Medi-Physics, 708-593-6300, ext. 244; or Joan Reisman of Makovsky & Company, 212-532-6300, for Medi-Physics, Inc., Amersham Healthcare/
 (CYTO)


CO: Medi-Physics, Inc., Amersham Healthcare; Cytogen Corporation ST: Illinois, New Jersey IN: MTC SU: PDT

GK-OS -- NY025 -- 0630 12/30/92 13:22 EST
COPYRIGHT 1992 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1992 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Dec 30, 1992
Words:652
Previous Article:LIDAK PHARMACEUTICALS REPORTS YEAR-END FINANCIAL RESULTS
Next Article:OCCIDENTAL CHEMICAL TO ACQUIRE ACL BUSINESS OF MONSANTO
Topics:


Related Articles
CYTOGEN AND CETUS ANNOUNCE UNITED KINGDOM AND THE NETHERLANDS APPROVALS FOR ONCOSCINT CR103 CANCER IMAGING AGENT
CYTOGEN AND CETUS ANNOUNCE DENMARK APPROVES ONCOSCINT(R) CR103 CANCER IMAGING AGENT
CYTOGEN CORPORATION ANNOUNCES DIVIDEND PAYMENT ON CONVERTIBLE EXCHANGEABLE PREFERRED STOCK
CYTOGEN INITIATES CLINICAL TRIALS FOR IMAGING BREAST CANCER
CYTOGEN AND CETUS ANNOUNCE SPAIN APPROVES ONCOSCINT(R) CR103 CANCER IMAGING AGENT
CYTOGEN AND CHIRON ANNOUNCE ITALY APPROVES ONCOSCINT(R) CR103 CANCER IMAGING AGENT
CYTOGEN INITIATES CLINICAL TRIALS OF THROMBOSCAN(TM), THE WORLD'S FIRST MRU PRODUCT
IMMUNOMEDICS FILES FOR PRODUCT MARKETING APPROVAL IN CANADA; PRODUCT CONSISTS OF ADVANCED CANCER DETECTION METHOD
CYTOGEN ANNOUNCES REVISION OF STRATEGIC PLAN
CYTOGEN: FDA APPROVES ONCOSCINT(TM) CR/OV FOR REPEAT ADMINISTRATION

Terms of use | Copyright © 2016 Farlex, Inc. | Feedback | For webmasters