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Executive Summary

SYNERGEN's IL-1ra CLINICALS FOR SEPTIC SHOCK expected to begin during the first week of December, Synergen Chairman Larry Soll, PhD, told a Nov. 28 Robertson Stephens Medical Conference in New York City. "The FDA has approved our protocols" for the interleukin-1 receptor antagonist, he said, and two trials "will begin next week." The Boulder, Colo.-based company filed an IND for the sepsis indication last month. Sepsis is the second indication Synergen will investigate with Il-1ra; the company began Phase I testing for rheumatoid arthritis "in September," Soll reported. The first trial involving a single dose in patients "showed the drug to be quite safe," Soll indicated. "Sometime during December we will begin multiple dose trials which will be a combination safety and efficacy." Soll described one "pleasant surprise" from the first trial: the half-life of the drug was four times longer than expected, raising the possibility that the product could be dosed once a day or once every two days. Synergen reacquired worldwide rights to IL-1ra this year. The product was previously licensed for joint development with Hoffmann-La Roche in May of 1989. Roche had the rights to develop oral analogs of the product. Two more INDs for IL-1ra are planned for early next year: first for inflammatory bowel disease and then for two "relatively rare" forms of leukemia -- acute myelogenous and chronic myelogenous leukemia. The first week of December will apparently be a busy one for Synergen. Company President and CEO Jon Saxe earlier told the Robertson Stephens conference that the company "should hear momentarily" from FDA regarding two INDs filed in October for SLPI. The human elastase inhibitor will be examined in 15 cystic fibrosis patients and in 15 genetic emphysema patients, Saxe said. The company expects to begin those trials "next week" and to have results "late in the first quarter or early in the second quarter" of next year, Saxe added. SLPI is another product which Synergen reaquired: it regained worldwide rights to the product from Ciba-Geigy in February. Synergen's first product, Trofak, a basic fibroblast growth factor (bFGF), is in advanced clinicals for diabetic and venous stasis ulcers. Saxe indicated that Phase III trials are under way, with 175 out of an eventual 200 patients recruited for one study, and the first dosings for a second trial having begun "two days ago." The product has moved through clinicals at a rapid clip. Saxe said the company expects to file an NDA for Trofak by the end of 1991 or the beginning of 1992. Trofak was the first recombinant fibroblast growth factor to reach clinicals, in May of 1989.

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