Human Genome hopeful on tests

Skin drug appears effective

new set of trials also OK's

Biotechnology

May 24, 2000|By Julie Bell | Julie Bell,SUN STAFF

Human Genome Sciences made double-barreled announcements yesterday about its protein wound-healer repifermin, saying the treatment showed promise and was "well-tolerated" in Phase II tests on skin-ulcer patients and - separately - that it had been approved for Phase II testing on patients with a painful gastrointestinal disease.

Dr. David C. Stump, the company's senior vice president for drug development, called the two developments "great announcements for our product." But the company's shares dropped $9.25, or nearly 11.5 percent, to close at $71.25 on the Nasdaq stock market as the overall market fell.

Phase II trials are the second step in a three-part human testing sequence required by the U.S. Food and Drug Administration to prove the safety and effectiveness of a proposed treatment. The Rockville company also is testing repifermin in Phase II trials on cancer patients to help determine whether it is safe and can prevent mucositis - characterized by painful mouth and throat sores - caused by chemotherapy.

Human Genome Sciences Inc. released only generalities yesterday about the Phase II results in patients with venous ulcers, the skin lesions that can appear over varicose veins on the ankle or lower leg. The company said it would provide the final data in September at the World Wound Healing Congress in Australia.

But Dr. Martin Robson, a professor of surgery at the University of South Florida and a clinical trial investigator for repifermin who will present the final data, said in a statement that the results were "very promising." The company said a full analysis of the data would be done over the summer.

In the trials, a measured dose of liquid repifermin was spritzed twice weekly on patients' ulcers. About 94 patients were involved in the trials. Thirty-one patients were given a lower dosage; 32, a higher dosage; and 31, a placebo.

Stump said the company was encouraged by the results, which showed "positive drug activity" as measured by parameters such as the percentage of patients achieving partial wound closure.

Repifermin, also known as Keratinocyte Growth Factor-2 or KGF-2, is a naturally occurring growth factor activated when there is a wound in the epithelial tissue, which lines the body's mouth, throat, gastrointestinal tract and several other organs.

The Phase II clinical trials should help HGS determine whether the treatment is safe and effective against ulcerative colitis. About 325,000 people in the United States suffer from that disease, which is characterized by abdominal pain, rectal bleeding, diarrhea, fever and fatigue.

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