Epigen Inc. (ASE:EPN.EC) announced Tuesday that it has filed aU.S. patent application covering its proprietary humancarcinoma antigen (HCA), HCA antibodies, HCA immunoassaysand novel methods of imaging and therapy.
HCA is a mucin glycoprotein generally found in large quantitieson the cell membranes of carcinomas but not in normal tissue.
The Wellesley, Mass. firm's first three products are covered bythis patent application. The first is an in vitro test--termed theCOD test-- to measure the level of HCA in thebloodstream.Epigen researchers have found that not only isHCA present in ther bloodstream, but that there is a correlationbetween the amount of HCA and the patient's tumor burden.
Epigen has designed this test to measure the effectiveness ofcancer treatment, and once the patient is in remission, to revealwhether the cancer is recurring. Patients will be monitoredmonthly for at least a year following treatment. The first targetwill be breast cancer.
Although there are approved tests for detecting and/ormonitoring colon, ovarian and prostate cancers, "there is noapproved product in the U.S. to monitor breast cancer patients,"according to James Mongiardo, Epigen's president and chiefexecutive officer. He predicts those clinical trials should beginin the first half of 1993.
Epigen is also developing an in vivo imaging agent. The HCA-monoclonal is tagged with 111Indium, and will be injected intothe patient so the tumor's location can be plotted byscintographic imaging. The agent could also be used as a post-operative check to determine if all the cancerous tissue hasbeen removed. Mongiardo said that the company expects to filean investigation new drug (IND) in the second quarter of 1993and should begin combined Phase I/II trials at New York'sColumbia Presbyterian Medical Center sometime in the thirdquarter.
The FDA has to date approved only one monoclonal antibody-based in vivo imaging agent--Cytogen Corp.'s (NASDAQ:CYTO)OncoScint, for detecting colorectal and ovarian cancer. And nowthat FDA has decided what the appropriate standards are forapproval for this type of product, "it makes it much clearer"what FDA requires, Mongiardo told BioWorld.
Epigen's patent application also covers anti-idiotypicmonoclonal antibodies to be used as vaccines to treatcarcinomas. The "anti-ids" are designed to behave like purifiedHCA and activate an immune system response to attackmalignant tumors, including breast, lung, prostate and coloncancers. The vaccine program is "still in the research stage,"said Mongiardo.
Epigen, whose shares are traded in the American StockExchange's Emerging Company Marketplace, closed Tuesday at$1.88, down 13 cents a share. The firm has 4.67 million sharesoutstanding, and had $3 million in cash at the end of 1992,Mongiardo said.
-- Jennifer Van Brunt Senior Editor
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