Wednesday, Feb 28, 1990
South San Francisco, Calif. -- February 28, 1990 --Genentech, Inc. today announced that human clinical trials of relaxin have begun. The company plans to investigate the effects of the hormone, now produced by recombinant DNA technology, in facilitating childbirth.
The Phase I studies are being conducted at three centers: The University of North Carolina at Chapel Hill, University of California, San Francisco and University of Utah, Salt Lake City. In order to conduct these safety trials, non-pregnant women volunteers will be studied.
Relaxin is a naturally-occurring hormone that is produced in highest levels by the female reproductive organs during pregnancy. It appears to have a role in childbirth by relaxing, or softening, the cervix and birth canal. Through a series of clinical trials, Genentech will be evaluating relaxin's potential to facilitate safe and natural childbirth in women who, near the end of pregnancy, suffer complications of toxemia or diabetes, or who are more than 3 weeks post-due.
Barry Sherman, M.D., vice president of medical affairs at Genentech cautions that relaxin is in early investigational studies and must undergo extensive human clinical trials over a period of several years. "If relaxin is proven to be safe and efficacious in child bearing women, it may provide a cost-efficient and non-invasive alternative to cesarean section delivery in certain women."
Relaxin is Genentech's fourth product to begin human clinical trials in the last 7 months; the first new product into the clinic in 1990. In the third quarter of 1989, Genentech began Phase 1 trials of Argatroban, a blood clot-inhibiting agent; CD4-IgG, a second generation potential AIDS therapeutic; and IGF-1, a protein which is believed to have a role in treating a variety of nutritional and growth disorders.
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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