Agennix's Topical Talactoferrin Improved Healing Of Diabetic Ulcers

Results from a Randomized, Placebo-Controlled, NIH-Sponsored, Phase II Trial Presented at ADA

Houston -June 13, 2005- Agennix Incorporated announced results from a randomized, placebo-controlled, NIH-sponsored, multi-center Phase II clinical trial evaluating topical talactoferrin alfa (talactoferrin) in diabetic neuropathic ulcers. The trial met its primary endpoint -- incidence of at least 75% healing at the end of dosing (week 12) relative to baseline. Results from the trial will be presented today at the 2005 Annual Meeting of the American Diabetes Association (ADA) in San Diego.

Patients receiving talactoferrin had double the incidence of 75% or greater healing compared to patients receiving placebo gel. There were no talactoferrin related adverse events or laboratory abnormalities.

Dr. Aristidis Veves, Research Director of the Joslin-Beth Israel Deaconess Foot Center and Associate Professor of Surgery at Harvard Medical School, who was a principal investigator in the trial, commented: "This data is very encouraging. It shows that topical talactoferrin may substantially improve wound healing in diabetic ulcers. There is a tremendous and growing need for new drug therapies in this indication. Assuming confirmation of these results in a Phase III trial, I would expect talactoferrin to be broadly used."

About the Study
The goal of this randomized, placebo-controlled Phase II study was to determine if topical talactoferrin increases the incidence of wound healing in patients with diabetic neuropathic ulcers. A total of 55 patients participated in the two-part study. In part one, groups of three patients each received 1%, 2.5% or 8.5% talactoferrin gels in a sequential design, with twice-daily administration to the ulcer for 30 days. No drug-related adverse events were found at any dose level, and no patient had any infection of the target ulcer during the dosing period. Part two of the study was a randomized, placebo-controlled evaluation of 2.5% and 8.5% talactoferrin gels. Patients were equally divided between the three arms (two talactoferrin concentrations and placebo). In combination with good wound care, the gels were administered directly on the ulcers twice daily for 12 weeks. The study was supported by $850,000 in grant funding awarded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at the National Institutes of Health (NIH).

About Topical Talactoferrin Alfa
Topical talactoferrin alfa is a novel agent that has demonstrated wound healing activity in animals and in patients with diabetic ulcers in a Phase II trial. In healthy animals with either uninfected or infected wounds, and in diabetic animals with impaired healing, topical talactoferrin consistently and dramatically increased the rate of wound healing and the incidence of closure relative to animals treated with placebo. Talactoferrin was also shown to be more effective than becaplermin (Regranex(TM)) in animal experiments. Talactoferrin has been administered to over 500 people and appears to be safe and well tolerated.

About Chronic Wounds And Diabetic Ulcers
There are approximately 12.5 million patients worldwide with chronic wounds that do not repair or that do so extremely slowly. Chronic wounds are a major burden on society with estimated costs of over $5 billion per year. These costs are expected to increase by 10% annually. Diabetic foot ulcers, venous ulcers, and pressure ulcers comprise the majority of chronic wounds. About 16 million people in the United States have diabetes and over 50% of all lower extremity amputations in the United States are related to diabetes. Approximately one in every seven diabetics suffers at some time from one or more diabetic foot ulcers. About 800,000 people per year in the United States require treatment for diabetic foot ulcers.

About Agennix
Agennix, a privately owned Houston-based biopharmaceutical company, is developing patented protein and peptide drug candidates including talactoferrin alfa (talactoferrin), an immunomodulatory protein. Talactoferrin appears to be safe and well tolerated after administration to over 500 people, and appears to be effective in treating cancer and diabetic foot ulcers. Agennix holds 76 patents including broad composition of matter coverage. The Company has seven Phase II human clinical trials currently underway in the treatment of cancer and diabetic foot ulcers, with company sponsored U.S. INDs in both areas.

More information about Agennix is available on the Company's web site at http://www.agennix.com.