Agennix Inc. raised $22 million privately to fund continued clinical development of its recombinant human lactoferrin (rhLF) in cancer and diabetic foot ulcers.

Existing shareholders participated in the financing, along with new investors that included biotech company executives and several corporations. To date, the private company has raised about $86 million.

The latest round will fund Phase II trials and the initiation of Phase III trials of Agennix's most advanced compounds based on rhLF, a multifunctional protein found in human milk and other endocrine secretions, CEO Rick Barsky said.

"It will also extend our cash life into the middle of 2007," he told BioWorld Today.

Agennix has seven ongoing Phase II trials, including four trials in patients with non-small-cell lung cancer and renal cancer. Barsky said he expects to start seeing data from those trials within the next few months. Based on the results, the company plans to move forward in pivotal trials of rhLF in those indications.

"When we start those, we may look to bring in some more financing," he said, adding that Agennix had no definite plans to go public, though "that is something we'll consider once we have the data."

Studies of lactoferrin are based on its immunostimulatory mechanism of action. In cancer treatment, rhLF is designed as an orally administered liquid that binds to specific receptors in the gastrointestinal tract, leading to a cascade of events that involves the attraction and maturation of dendritic cells, and stimulates the production of cytokines such as interferon-gamma, interferon-alpha, IL-18 and IL-12. That cytokine production then stimulates the activation of immune cells, including CD4+, CD8+ and NK cells that, ultimately, kill cancer cells, Barsky said.

"Because of the mechanism involving the stimulation of immune responses, it really is a drug that could have applicability to a lot of different cancer types," he said, adding that the potential for a broad application is "one of its attractions."

Another attraction is its safety. In preclinical and clinical studies to date, the company has reported no lactoferrin-related serious adverse events.

"We are likely to do some additional trials in some other cancer types, both with lactoferrin as a single agent and in combination with approved chemotherapies," Barsky said.

In addition to cancer, Agennix also is investigating rhLF in wound healing, specifically in patients with diabetic foot ulcers. In those studies, the product is administered as a topical gel, and its immunostimulatory mechanism increases the production of GM-CSF, which accelerates wound healing.

With its recombinant technology, Houston-based Agennix is the first to produce commercial quantities of human lactoferrin for pharmaceutical purposes. The company has 76 issued patents and more than 50 patents pending to protect its recombinant protein, manufacturing process and clinical applications.

Barsky described Agennix as "somewhat of a virtual company" that handles the design for experiments, clinical trials and the manufacturing process "but really outsources most of the work in all three areas." The company has about 15 full-time employees.