The first data from Human Genome Sciences Inc.'s repifermin keratinocyte growth factor-2 for venous ulcers are hardly overwhelming. However, neither are the data for the two approved products, implying that the hurdles HGSI has to overcome may not be all that high. Thus while Phase IIa data released last week imply that the company will have to do some careful trial design to come up with an approvable product, similar experiences at other companies should provide some guideposts.

Ulcers in general, both diabetic and venous, have proved difficult. In clinical trials, patients get best standard care and compliance is monitored, which in and of themselves are fairly effective in healing ulcers. "Wound healing trials are notoriously difficult to perform," noted Gail Naughton, president and COO of Advanced Tissue Sciences Inc. (ATIS, La Jolla, Calif.). "Patient compliance is so key."