Gene research yields drug that helps heal chronic ulcers, company announces

WASHINGTON (CNN) - The study of human genes has yielded a medicine that hastens healing of tissues in patients with chronic and often painful leg and feet ulcers.

The new drug also may help millions of people with diabetes, inflammatory bowel disease or swollen and reddened mucous membranes. Oral mucositis often plagues cancer patients receiving chemotherapy or radiation therapy.

Officials of Human Genome Sciences Inc. (HGS) of Rockville, Maryland, announced on Wednesday promising results from clinical trials of repifermin, a protein also known as Keratinocyte Growth Factor-2 or KGF-2.

"Repifermin accelerates healing of chronic venous ulcers, and its safety profile is excellent," said Dr. Martin Robson, professor of surgery at the University of South Florida and principal investigator for the trials.

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Citing the drug's "strong potential as a wound-healing agent," Robson presented clinical data on repifermin to participants in the World Wound Healing Congress, in Melbourne, Australia.

Patients in the double-blind study were randomly assigned to one of three treatment groups, said Dr. David C. Stump, HGS senior vice president for drug development. Thirty-one patients were treated with topically applied repifermin at 20 micrograms (mcg) of the drug per square centimeter of open venous wound. Thirty-two patients received the drug at 60 mcg, and 31 patients got a placebo.

After two applications a week for up to 12 weeks, the groups' rates of wound closure were measured. Stump said 53 percent of the 60-mcg patients, 55 percent of the 20-mcg patients and 36 percent of the placebo patients had at least 90 percent wound closure.

Venous ulcers are caused by blood pooling in the extremities. Swelling, often over a varicose vein, occurs along with redness and scaling of the skin. As the skin becomes inflamed, it ulcerates into open wounds that may take months to heal. Reinfection is common, and some venous ulcers do not heal.

An estimated 600,000 patients in the United States suffer from such ulcers - "a major unmet medical need," said Stump.

The key chemical in the medication is "a natural substance that your body uses to heal wounds to the skin and the inner lining of the intestine," said William Haseltine, chairman and chief executive officer of HGS.

"We isolated the gene that makes the substance," he said. "We manufacture it and put it on wounds to the skin."

Repifermin prompts a proliferation of tissue-growth cells and cells that give a protective covering or lining to injured tissue. The drug is expected to work with other problem wounds, especially those with inadequate blood and nutrient supply.

"We think this new drug holds promise for the treatment for chronic wounds such as pressure ulcers and diabetic foot ulcers," said Stump.

The medication is being tested in other clinical trials, including treatment for patients with ulcerative colitis, a type of inflammatory bowel disease, and patients with damaged mucosal tissues, a common reaction to cancer treatments.

"We are currently finalizing the details of the next trial, which will be a study in over 600 patients evaluating the efficacy of repifermin for complete healing of venous ulcers," said Stump.

About 6 million people worldwide suffer from chronic wounds, he said. Venous ulcers, pressure ulcers and diabetic foot ulcers account for most of the chronic wounds.

Stump said pressure ulcers occur when too much pressure is applied to one area of a person's body for a prolonged period, often while bedridden. Buttocks, backs of heels and hips are common areas.

Diabetic foot ulcers, he said, occur in 10 percent to 15 percent of the 16 million diabetics in the United States, frequently caused by vascular and neurological complications.

Further testing and federal approval may take three to five years before the medicine is publicly available, said Stump.

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National Center for Chronic Disease Prevention and Health Promotion

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