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 KRAKOW, Poland, Aug. 18 /PRNewswire/ -- Epigen, Inc. (AMEX-ECM: EPN.EC), a biopharmaceutical company organized to develop and commercialize cancer products, announced today that its founding scientist, Dr. John Codington, Boston Biomedical Research Institute and Department of Biological Chemistry and Molecular Pharmacology, Harvard Medical School, presented data on the company's cancer marker and "COD" test to the XII International Symposium on Glycoconjugates in Krakow, Poland.
 The COD Test is Epigen's proprietary product currently in pre- clinical testing. It is an immunoassay for determining the concentration of the carcinoma-specific antigen discovered by Dr. Codington, the Human Carcinoma Antigen (HCA), in the blood of cancer patients. Epigen research has shown a correlation between the amount of HCA shed into the bloodstream and cancer burden.
 Dr. Codington said that "Immunoassays for the quantitative determination of a human carcinoma-specific antigen (HCA) in the blood of patients with epithelial derived cancer have been developed." These assays were made possible by the discovery that HCA shares a common epitope with the mucin-type glycoprotein, epiglycanin, present at the surface of the mouse mammary carcinoma ascites cell, TA3-Ha, and is present in the blood of mice bearing this tumor in ascites form.
 The assays reported on by Dr. Codington utilized monoclonal antibodies prepared from the B cells of immunized mice as well as polyclonal antibodies prepared in rabbits. Assays employing monoclonal and polyclonal antibodies, as well as lectins, in a sandwich format were developed by Epigen's scientists. In addition, competitive binding immunoassays have been successfully used. These include radioimmunoassays in which the radioactively labeled antigen is used to determine the inhibition of the formation of a radioactive antigen- antibody complex when human serum is used for measuring the concentration of HCA in the bloodstream. Competitive binding assays have employed antigen immobilized on solid supports. The concentration of antibody bound to the antigen is determined by the use of a second antibody labeled with an enzyme such as alkaline phosphatase.
 Epigen is developing the COD test to be used to monitor cancer patients. This test will have a higher degree of sensitivity and specificity than other blood tests currently available. In a double blind study using a polyclonal antibody radioactive immunoassay of the plasma of 87 women with breast disease, a correlation was shown between tumor burden and the concentration of HCA in the blood. Data was presented which demonstrates that for monoclonal antibody enzyme immunoassays, it now appears possible to detect with the COD Test all carcinomas (100 percent sensitivity) with a specificity of greater than 80 percent.
 These results are important since carcinomas, which represent the common cancers such as breast, colon, lung, and prostate, constitute approximately 84 percent of all cancer in the United States. At present, no adequate assays exist for the detection of all carcinomas.
 Dr. Svein Haavik, Department of Pharmacognosy, Institute of Pharmacy, Oslo, Norway, and a member of Epigen's Scientific Advisory Board with Dr. Codington, presented data on the characterization of Epigen's Human Carcinoma Antigen at the same conference.
 Dr. Haavik's presentation "Isolation and Characterization of Glycoproteins from Human Carcinomas which cross-react with Epiglycanin" demonstrates that antibodies prepared against epiglycanin bind to glycoproteins on the surface of human carcinoma cells and that these glycoproteins are present in the blood of patients with epithelial cancers (carcinomas). Human Carcinoma -- specific antigen (HCA) was isolated from the spent medium of a human endometrial carcinoma cell line grown in culture and from the ascites fluid of a patient with ovarian carcinoma. HCA was purified from both sources by combined use of Filtron Ultrasette, gelfiltration chromatography on columns of Sepharose CL-2B, and by immunoaffinity chromatography using columns with immobilized mouse monoclonal IgM antibodies raised against epiglycanin. The majority of the HCA active materials were high molecular weight (1-2 million kDa) mucin-type glycoproteins. Smaller fragments were made of the isolated HCA by incubation with trypsin and/or Pronase. The formed glycopeptides were fractionated and characterized with special emphasis on the glycopeptide structures of their epiglycanin-cross reacting epitopes.
 This benchmark work to characterize Epigen's HCA, which led to Epigen's recent patent filing, was supported by both Epigen and the Norwegian Council for Science and the Humanities.
 Epigen expects to begin clinical trials for the COD test in the fourth quarter of 1993. Other Epigen products, based upon production of monoclonal antibodies to HCA, include a tissue staining test to be used by pathologists as a way of determining whether a patient has prostate cancer which is expected to be available in the fourth quarter, an in vivo imaging agent to confirm a carcinoma diagnosis and stage patients for which an IND is expected to be filed in the fourth quarter with clinical trials beginning shortly thereafter, and a vaccine to treat carcinomas for which clinical trials are expected to begin in 1994.
 -0- 8/18/93
 /CONTACT: James F. Mongiardo, president of Epigen, Inc., 617-237-9102, or William Doyle of Strategic Marketing Systems, 212-888-3883, for Epigen, Inc./

CO: Epigen, Inc. ST: Massachusetts IN: MTC SU:

LD-TM -- NY003 -- 3779 08/18/93 08:51 EDT
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Publication:PR Newswire
Date:Aug 18, 1993

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