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CHIRON INSULIN GROWTH FACTOR CLINICAL STUDIES

Executive Summary

CHIRON INSULIN GROWTH FACTOR CLINICAL STUDIES are underway in Switzerland as part of a joint venture with Ciba-Geigy, Chiron President Edward Penhoet told a recent financial seminar sponsored by Cowen & Company in Boston. Penhoet indicated that the first use under study is the treatment of a subpopulation of dwarfs (Laron Dwarfs) that do not respond to human growth hormone. The product is being studied in Zurich by Dr. Froesch. The company has not filed an IND yet for U.S. studies. IGF, Penhoet told the analysts, "is directly involved in growth in the body -- actually when human growth hormone causes growth it does so primarily by stimulating the liver to make IGF. And it is IGF that actually interacts with bone and muscle mass to cause growth." The long-term goal of the Chiron/Ciba-Geigy venture with IGF, Penhoet said, is "to impact the great diseases of aging -- primarily loss of muscle mass or bone mass." Specifically, Penhoet identified osteoporosis as "one of the major targets of this program." Chiron's development effort on epidermal growth factor (EGF) is further advanced than the early IGF clinical work. Penhoet noted a recent report on the efficacy of EGF in 12 skin transplant patients to heal donor site wounds. The donor site study was conducted at the University of Louisville, Emory and Vanderbilt. The studies compared Silvadene cream and EGF with Silvadene cream alone. An abstract of the study was reported recently, Penhoet said, at the Keystone Conference in Colorado. "Dr. Brown's study showed that the epidermal growth factor treatment of the human donor site wounds resulted in about a 30% acceleration in the rate of wound healing in those studies," Penhoet reported. "So, whereas the control group healed in about 11 days, the group treated with EGF as a whole healed in an average of 8 days." Penhoet maintained that "this is a significant increase in the rate of wound healing in a simple model." Penhoet also noted that "there is also a very real possibility . . . that EGF will also result in the treatment of . . . decubitus ulcers and wounds of that class." The Chiron exec said that the company is "doing clinical studies now on those uses also." Chiron also is involved with J&J's Ethicon division in the development of EGF for products for the wound closure market -- currently estimated at a $750 mil. per year market. Suspended ophthalmologic studies on EGF may be restarted by "midyear," Penhoet told the Cowen group. The company halted trials on the substance for corneal defects at the beginning of this year ("The Pink Sheet" Jan. 25, T&G-6). Reiterating the public reports by the company at the time of the study halt, Penhoet said that "in contrast to the general wound healing program . . . where there was a decrease in pain, in our clinical trials in ophthalmology, a number of patients treated with the growth factor have actually reported more pain in their eyes as a result of the administration of the growth factor." In January, the company speculated that the formulation of the product might be to blame; to the Cowen group, Penhoet said the most likely" explanation is interaction between EGF and other drugs being used by the patients in their eyes.
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