Agennix Inc. Presents Positive Results Showing Accelerated Wound Healing and Wound Closure with Topical Recombinant Human Lactoferrin

HOUSTON, June 18, 2003 - Agennix, Inc. announced results from animal experiments showing that topical recombinant human lactoferrin (rhLF) gel increased the rate and incidence of wound closure, relative to placebo and to the approved drug therapy. These results were presented by Dr. Jose Engelmayer and Dr. Atul Varadhachary in Seattle, at the 13th Annual Meeting of the Wound Healing Society. An abstract of the results was published in the March-April issue of the journal Wound Repair and Regeneration (volume 11, No. 2, A25).

There are 12.5 million people worldwide with chronic wounds (diabetic ulcers, venous ulcers, and pressure ulcers). Many of these patients suffer from severe complications such as leg amputations. Current therapy is only partially effective. RegranexT (recombinant-human platelet-derived growth factor-BB, becaplermin) is the only approved pharmaceutical product and shows 9-23% improvement over placebo and 4-22% improvement over good ulcer care alone in published studies of diabetic foot ulcers. Thus, there is an unmet clinical need for more effective drugs.

RhLF accelerates wound healing in animal models, with a novel mechanism of action. Agennix tested the efficacy of rhLF in mice with open, full thickness wounds, using both healthy mice and diabetic mice with impaired healing. RhLF consistently increased the rate of wound healing and the incidence of closure relative to mice treated with placebo as well as those treated with the approved drug.

Healthy mice treated with 1% topical rhLF had a 38% increase in the incidence of wound closure over placebo, and a 36% increase over the approved drug, which was highly statistically significant (p<0.01). In diabetic mice, rhLF treated animals had an 83% increase in incidence over placebo treatment (p<0.01). Healing was also evaluated in mice with infected wounds, a clinically relevant condition that contributes to the blocking of healing. In these animals, rhLF treated animals had an 86% increase in incidence over placebo and a 71% increase over the approved drug, both of which were statistically significant. RhLF treatment also significantly increased the percent of wound closure on each of the measurement days, compared to both placebo and the approved drug.

RhLF treatment appears to be safe and well tolerated. RhLF has been administered to over 300 people (149 topically and 200 orally) without a single serious drug related adverse event. Agennix has a blinded, multi-center Phase 1/2 clinical trial currently underway at Joslin-Beth Israel Hospital (Harvard University) and New York University School of Medicine, to evaluate the safety and efficacy of topical rhLF in patients with diabetic foot ulcers. After the initial dose escalation phase, which has completed enrollment, patients will be randomized between placebo and two doses of rhLF. Results from the efficacy phase of the trial are expected in early 2004.