Subject: EPO May Ease Effect of AZT, Researchers Say Date: Published: 10/14/88 79 lines Source: Wall Street Journal. Copyright Dow Jones & Co. Inc. Technology and Medicine: EPO May Ease Effect of AZT, Researchers Say ---- By Michael Waldholz Staff Reporter of The Wall Street Journal The highly promising drug EPO may help counter the severe anemia that often accompanies the use of AZT, the only drug approved for treating AIDS, according to a preliminary study. EPO is an experimental, genetically engineered version of a natural human hormone called erythropoeitin. Several companies are intensively studying EPO as a treatment for serious forms of anemia that result from a variety of health problems. AZT can cause an anemia so severe that many AIDS patients must receive monthly blood transfusions or quit using the drug. The study of the drug in combination with AZT is being sponsored by Johnson & Johnson's Ortho Pharmaceutical Corp. unit. Ortho is studying EPO under a license from Amgen Inc., the Thousand Oaks, Calif., biotechnology company that produced the gene-spliced version. The preliminary review looked at 63 patients with acquired immune deficiency syndrome who are receiving AZT at nine medical centers around the country. In a "large subset" of the patients, there was about a 60% to 70% reduction in blood tranfusions after three months of treatment with EPO. Details of the study were released Wednesday by Seth Rudnick, an Ortho official, at the annual meeting of the American Association of Blood Banks in Kansas City, Mo. A spokesman for Ortho said the company released the data after consultation with officials at the U. S. Food and Drug Administration. Ortho and the FDA were concerned that news of the drug's effectiveness might be misinterpreted to mean that EPO was, on its own, a treatment for AIDS. A spokesman for the FDA acknowledged that "since the study looked good," it was appropriate to release the preliminary findings. The Ortho spokesman said that the company will continue enrolling more patients in the EPO-AZT study and that it hopes to seek FDA approval "soon" to market the drug. Johnson & Johnson, based in New Brunswick, N. J., has the rights to market EPO in the U. S. under the brand name Eprex for treating most forms of anemia that result from surgery-related infections and other ailments. Johnson & Johnson already has approval to sell Eprex in several European countries. Amgen is awaiting FDA approval to market EPO for one use, as a way to counter the anemia that accompanies kidney dialysis. AZT, which is marketed by BurroughsWellcome Co., a unit of London-based Wellcome PLC, often causes bone marrow suppression and a drop in certain white and red blood cells. EPO naturally stimulates the bone marrow to produce red blood cells. Another genetically engineered agent, called GM-CSF, is being tested as a way to boost white cell production. EPO is widely considered by securities analysts to be a potentially big-selling drug, perhaps the next big product to come out of the biotechnology industry. Many analysts estimate that the U. S. market for EPO will exceed $200 million annually by the early 1990s. The drug is also being developed by Genetics Institute Inc. of Cambridge, Mass., which has licensed its version to a joint venture between Upjohn Co. of Kalamazoo, Mich., and Chugai Pharmaceuticals Inc. of Japan. In September, the joint venture applied for FDA approval of the drug for sale under the name Marogen. In New York Stock Exchange composite trading yesterday, Johnson & Johnson shares rose $1 to close at $86. In national over-the-counter trading, Amgen shares closed at $31.50, up 25 cents. [This article is made available here by Dow Jones Co. for the personal and non-commercial use of callers to this bbs, in the hope that it will be of some help to those who are suffering from the disease and others who are seeking to help them.]