Senior Staff Writer

Agennix Inc. raised $20 million privately to fuel a series of clinical trials being planned with its lactoferrin-based platform.

"We'll use the funds in two main categories," said Rick Barsky, CEO of Houston-based Agennix. "One is clinical trials and the second is scaling up our manufacturing. We are moving into a larger manufacturing facility that will use a 35,000-liter fermenter - we're using a 15,000-liter fermenter now."

The additional manufacturing capacity will come in handy, as Agennix expects to have five Phase II or Phase I/II trials under way by the end of the third quarter. The company holds 40 patents and has 65 pending and says it is "the first and only company to manufacture substantial quantities of human lactoferrin."

Lactoferrin is a multifunctional protein found in human milk and other endocrine secretions. It helps stimulate the immune system to fight cancer and infections, and protect against asthma and other allergic diseases.

"The mechanism of action here we believe is that lactoferrin up-regulates interleukin-18," Barsky told BioWorld Today. "And that up-regulation stimulates production and increases the effectiveness of immune cells that kill cancer cells and harmful pathogens."

Agennix is applying that mechanism of action to an array of diseases. It has a double-blind, placebo-controlled Phase II study ongoing in 15 centers in the UK, Germany and Belgium to test oral lactoferrin against mucositis in patients undergoing myelosuppressive regimens of chemotherapy. Interim data from 80 patients should be available in August, Barsky said, with enrollment scheduled to complete in September.

The company expects to start two Phase II trials - one this quarter and one next quarter - examining oral lactoferrin in "a variety of solid tumors," Barsky said. Agennix is expected to initiate a Phase I/II trial in asthma patients next quarter, as well.

Agennix's fifth expected trial is in graft-vs.-host disease, also a Phase II study, giving it five Phase II or I/II trials ongoing or completed by the end of 2002, with potentially more on the way.

"We do have other indications in the pipeline," Barsky said. "We have patented peptides that are in preclinical development." Barsky added that Agennix might license out certain indications in the early stages.

Agennix began operations in 1993 and has been funded through smaller rounds of financing since then, Barsky said. The $20 million round is its largest and gives the company a raised-to-date total of $64 million. It won't be long until Agennix is looking for more, perhaps as early as the end of the year, he added.

"The next step will probably be another round," Barsky told BioWorld Today. "And shortly after that, we'll consider an [initial public offering], based on market conditions."

The company's largest shareholder is Gordon Cain, the lead investor in the $20 million round and also Agennix's chairman. He and others "who have been involved in the company and believe in the technology," Barsky said, were the key to raising the funds in a difficult financial environment. With the trials on the horizon, 2003 could be a pivotal year for the company.

"We have a substantial amount of data that say that human lactoferrin given orally is safe," he said. "More than 240 patients have been given it [worldwide.] The question is efficacy in the indications we are targeting. We think the Phase II data will add a lot of value to Agennix."

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