AEGiS-PRn: IGEN Licenses HIV-1 p7 Capsid Assay From National Institutes of Health; Potential New Marker of AIDS Progression

Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.

IGEN Licenses HIV-1 p7 Capsid Assay From National Institutes of Health; Potential New Marker of AIDS Progression

PR Newswire, 18 December 1996.

GAITHERSBURG, Md., Dec. 18 /PRNewswire/ -- IGEN International, Inc. (Nasdaq: IGEN) announced today that it has obtained worldwide rights to a novel immunoassay for detection and quantitation of human immunodeficiency virus (HIV-1) from the U.S. National Institutes of Health (NIH). IGEN intends to develop the test for clinical research use in combination with its proprietary ORIGEN(R) detection technology. The HIV-1 p7 immunoassay, which detects levels of a protein known as nucleocapsid antigen p7, promises to have advantages over existing HIV-1 quantitation methods.

Plasma viral load, or viremia, is currently recognized as the single most important indicator of successful anti-AIDS drug treatment and as a more accurate indicator of disease progression than CD4 levels. According to Dr. Richard Massey, IGEN's President and Chief Operating Officer, "The current commercial assays for quantitation of viral load are nucleic acid-based, requiring amplification of HIV RNA. Since immunoassays are faster, less expensive and less complex to perform than nucleic acid-based assays, we believe that the p7 assay, in combination with IGEN's highly sensitive ORIGEN technology may prove to be an accepted marker for AIDS progression and prognosis, and for determining the effectiveness of new AIDS drug treatments."

The HIV-1 p7 assay is covered by a U.S. patent and is based on the work of Dr. Larry O. Arthur and Dr. Louis E. Henderson of the AIDS Vaccine Development Program at the National Cancer Institute's Research and Development Center in Frederick, Maryland. IGEN has worked with Dr. Arthur, using its ORIGEN technology to enhance the sensitivity of his assay. Preliminary results show increased sensitivity over the commercially available p24 capture immunoassay.

According to Dr. Arthur, "The immunological assay currently used to measure plasma virus loads is an HIV-1 p24 capture assay, and antibodies to p24 present in infected persons interfere with this assay. The HIV-1 p7 capture assay does not suffer from this complication. Since p7 is found in equal molar quantities to p24 in the virus, it may be possible to develop a clinical HIV-1 p7 capture assay for quantitation of plasma levels of HIV-1 in infected persons." This property makes p7 a promising candidate for developing a more sensitive HIV-1 screening test, and may enable detection of blood borne virus at an earlier stage than is possible with existing clinical immunoassays.

The assay will be developed in collaboration with virologist Frank de Wolf at the University of Amsterdam. Professor de Wolf commented, "Because I am currently involved in a number of international HIV therapeutic trials, I am interested in developing the HIV-1 p7 assay as a faster, less expensive alternative to the RNA-based assays we are currently using for HIV quantitation."

IGEN develops, manufactures and markets diagnostic systems utilizing its patented ORIGEN technology, which is based on electrochemiluminescence. ORIGEN provides uniform assay formats to conduct a multitude of diagnostic tests including immunoassay, nucleic acid probe and clinical chemistry tests. Products using the IGEN technology include systems marketed by IGEN and its corporate partners, Boehringer Mannheim and Organon Teknika.

STATEMENTS IN THIS RELEASE THAT RELATE TO PRODUCT PERFORMANCE AND CUSTOMER ACCEPTANCE AND NEW PRODUCT PLANS ARE FORWARD-LOOKING STATEMENTS. ACTUAL RESULTS MIGHT DIFFER MATERIALLY FROM THESE STATEMENTS DUE TO RISKS AND UNCERTAINTIES, INCLUDING THE IMPACT OF COMPETITIVE PRODUCTS AND PRICING, THE TIMELY DEVELOPMENT AND ACCEPTANCE OF NEW PRODUCTS AND MARKET CONDITIONS. A MORE DETAILED DESCRIPTION OF THESE RISKS APPLICABLE TO IGEN APPEARS IN IGEN'S ANNUAL REPORT ON FORM 10-K FOR THE YEAR ENDED MARCH 31, 1996, FILED WITH THE SECURITIES AND EXCHANGE COMMISSION AND AVAILABLE UPON REQUEST FROM IGEN. IGEN DISCLAIMS ANY INTENT OR OBLIGATION TO UPDATE THESE FORWARD-LOOKING STATEMENTS.

IGEN and ORIGEN are registered trademarks of IGEN International, Inc.

CONTACT: George Migausky, Vice President and Chief Financial Officer of IGEN, 301-984-8000; or Amy Martini, investors, 212-696-4455, ext. 255, or Neil Cohen, media, 212-696-4455, ext. 205, of Noonan-Russo Communications/ 09:28 EST

Keywords: HIV; IMMUNODEFICIENCY; AIDS DRUGS; CD4

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