By Lisa Seachrist
WASHINGTON — Following positive Phase I results, Human Genome Sciences Inc. will move its wound-healing protein, keratinocyte growth factor-2 (KGF-2) into Phase II studies by the end of this year.
"This is the second product to come out of the genomics program [and enter efficacy testing]," said Craig Rosen, senior vice president of research and development for Rockville, Md.-based HGS. "We had several dozen growth factors that we identified. This one appeared to be the least likely to cause unwanted side effects."
In June, the company announced that its bone marrow sparing drug, myeloid progenitor inhibitory factor-1 (MPIF-1) would enter Phase II testing sometime this year.
One of many growth factors that stimulate a wound to heal, KGF-2 has very specific activity, Rosen noted. Whereas other growth factors stimulate the growth of a variety cell types, KGF-2 only acts on epithelial tissue — skin, the gastrointestinal tract and the lining of the mouth and lungs. As a result, KGF-2 is less likely to cause side effects.
In order to test how well KGF-2 is tolerated, the company compared the topical application of the drug in a number of doses to placebo. HGS tested the drug in 36 healthy volunteers who were wounded with punch skin biopsies. None of the subjects withdrew from the study or required a reduction in dose because of adverse events.
As a result, HGS will move to Phase II studies to test the effectiveness of KGF-2 in wound healing and to determine optimal doses. Rosen said the company envisions a series of small Phase II studies testing the drug in acute surgical wounds, pressure wounds, venous ulcers and burns in order to determine the indication the company will pursue first for marketing.
Could Work As Skin-Substitute Alternative
HGS also is testing the drug's safety as a systemic therapy in Phase I trials. While those studies have yet to be completed, Rosen said that the company is looking into systemic delivery to heal mucosal tissues that are damaged as a result of chemotherapy or inflammatory disorders. Patients on chemotherapy often develop mucositis of the mouth and gastrointestinal tract as a result of their therapy. A systemic version of the drug could one day treat lung damage and inflammatory bowel disease.
Alex Arrow, vice president of research for Wedbush Morgan Securities, in Los Angeles, called KGF-2 an extremely promising product in the field of wound healing.
"HGS got through their Phase I trials pretty quickly, so this could be very good news," Arrow said. "And they're going after the big wound care market. This product could become the front runner in the treatment of wounds because of the scope of indications."
Arrow said investors have favored skin substitutes as the blockbuster treatment of the future. However, he noted that Apligraf, the FDA-approved skin product from Organogenesis, Inc. of Canton, Mass., has had weaker sales than expected, and Dermagraft, a product developed by Advanced Tissue Sciences Inc., of La Jolla, Calif., has hit regulatory snares. (See BioWorld Today, Aug. 7, 1998, p. 1.)
If KGF-2 continues to progress rapidly, Arrow said, it could be a promising alternative to skin substitutes.
HGS's stock (NASDAQ:HGSI) closed Wednesday at $31, down $2.688. *