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Executive Summary

BRISTOL-MYERS INVESTING IN HUMAN SUPEROXIDE DISMUTASE DEVELOPMENT through an agreement with Bio-Technology General. Bristol-Myers is "undertaking responsibility for a clinical program to determine superoxide dismutase's therapeutic potential in the treatment of cardiac ischemia and in kidney transplantation," Bio-Technology General announced in a June 30 release. In return, Bristol-Myers has an option to acquire an exclusive worldwide license to sell human superoxide dismutase (hSOD) for human and veterinary uses. Bio-Technology General filed an IND in April, and FDA subsequently authorized clinicals for cardiac ischemia and kidney transplantation, the company said. Studies are scheduled to begin within 60-90 days at Johns Hopkins University, the University of Michigan and the University of Minnesota, Bio-Technology General said. The firm's sole IND is in the U.S. Noting the results of cardiac studies in rabbits, Bio-Technology General said that "rabbit hearts previously subjected to total blockage of blood flow retained only 30% of normal heart function when blood flow was restored (i.e., reperfusion)." However, when hSOD was administered at reperfusion, "heart function recovered to 75% of normal levels." The company noted that "comparably dramatic results have been achieved in experiments with dogs subjected to localized ischemia, simulating a heart attack. In those experiments, a greater than 50% reduction of heart tissue damage (infarct) was demonstrated." Bio-Technology General commented that "should hSOD's efficacy in humans match the activity so far demonstrated in animal models, the agent could prove to have significant medical potential in conjunction with clot-dissolving . . . agents such as streptokinase and TPA [tissue plasminogen activator] or with mechanical methods for the removal of clots (i.e., angioplasty)." The company plans to file an IND for use of the agent in treatment of oxygen toxicity in premature infants. Bio-Technology General noted that future research will consider hSOD for such indications as arthritis, lung disease and generalized shock. Human superoxide dismutase, which is derived from yeast or microbe sources through genetic engineering, is also being developed by Chiron and Pharmacia for tissue protection either during inflammation or following ischemia. The two companies announced completion of a 50-50 joint venture in February. A bovine-derived superoxide dismutase is being developed by DDI Pharmaceuticals for treatment of osteoarthritis. Approved in several European countries, an IND for the product is pending at FDA. SmithKline has first option to license the product from DDI.

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