Thursday, Sep 14, 1989
South San Francisco, Calif. -- September 14, 1989 --Genentech, Inc. announced today that human clinical trials of insulin-like growth factor (IGF-I) began last week. Genentech plans to investigate the activities of IGF-I in a variety of nutritional and growth disorders as well as in the area of tissue repair.
A Phase I human study is being conducted at the University of Utah Drug Research Center in Salt Lake City. The study, which will last about six months, will examine the safety and pharmacokinetics, or drug levels, of IGF-I use in humans.
IGF-I is Genentech's third product to begin human clinical trials in the last three months. In July, Genentech began trials of Argatroban, a blood clot-inhibiting agent, and in August the company began testing CD4-IgG, a second generation potential AIDS therapeutic.
IGF-I may be able to benefit severely ill persons such as those with extensive burns, or suffering from wasting conditions that deprive them of their normal ability to transform nutrients into products needed to support life. Current therapy is not always successful in treating patients who require intravenous nutritional support, because of severe illness or trauma. Animal studies indicate that IGF-I has the potential to help these patients, although that potential remains to be proven clinically.
Studies in animal models have shown that IGF-I facilitates transport of protein building blocks known as amino acids, into cells where they are used and that IGF-I further inhibits protein breakdown in cells. These results indicate that IGF-I may be able to preserve and restore muscle mass even in severely malnourished persons.
Since IGF-I is the chemical mediator of growth hormone action, it may be useful for the treatment of growth retardation due to growth hormone resistance, although this effect needs to be established in clinical trials.
IGF-I is in early investigational stages and must be proven in extensive human clinical trials over a period of several years.
Genentech, Inc. is a leading biotechnology company focusing on the development, manufacture and marketing of pharmaceuticals produced by recombinant DNA technology.
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