Arriva Pharmaceuticals Inc. stands on the precipice of its first clinical trials and, after closing its $28 million Series D round of financing, has the necessary funds to support them.

“This year we are going into the clinic with our programs,” said Martin Preuveneers, CEO and chairman of Arriva. “We are taking alpha 1-antitrypsin into the clinic for hereditary emphysema. Also, we will initiate trials in asthma. And we have developed a gel formulation [of alpha 1-antitrypsin] for atopic dermatitis [that will enter the clinic].”

Arriva, of Alameda, Calif. formerly AlphaOne Pharmaceuticals Inc. is partnered with the Baxter Bioscience unit of Baxter Healthcare Corp., of Deerfield, Ill., for the development of recombinant alpha 1-antitrypsin (rAAT) in hereditary emphysema, asthma and other respiratory indications. It has formed a joint venture with ProMetic Life Sciences Inc., of Montreal, called Arriva ProMetic, for the use of rAAT in dermatological purposes, including for atopic dermatitis. Preuveneers said it was those collaborations, among other things, that helped smooth the fund-raising trail in a difficult financial environment.

“It was hard work,” he told BioWorld Today. “You’ve got to demonstrate that you have something of substance in the company, and some prospects, too. But we’ve overcome many of the manufacturing issues, and we have two strategic corporate partnerships, as well.”

Not to mention rAAT on the verge of clinical trials. AAT is a naturally occurring protein that already is being used to treat hereditary emphysema under the name Prolastin, marketed by Bayer AG, of Leverkusen, Germany. That product is used as a replacement therapy for patients with little circulating AAT. However Bayer’s product is plasma-derived and given intravenously, which is where Arriva and its 20 employees see an opportunity.

Arriva’s product is recombinant AAT, derived from yeast. For the respiratory indications, the product will be administered to the lung via a “readily available” nebulizer, Preuveneers said. By manufacturing large amounts of the product for aerosol delivery, Arriva plans to sidestep the supply limitations of plasma-derived AAT, as well as the dangers of infectious diseases associated with blood products.

Baxter has worldwide rights for the respiratory indications and would market any approved products. Trials for emphysema are planned for the U.S., the asthma trials for Europe. For the dermatological indications, trials are scheduled for Canada, and Arriva is looking to bring aboard a third party for marketing purposes. Preuveneers said discussions are ongoing in that area.

The $28 million is expected to last Arriva “well into clinical development,” Preuveneers said. As far as future financings, like most private companies that have had several rounds of fund raising, Arriva aspires to be public. However, any decisions on that front will “depend on market conditions and the progress we are making through the clinic,” he said.

Founded in 1997 by Phil Barr, Allan Wachter and David Kent, the company then named AlphaOne Pharmaceuticals added Preuveneers in January 1999, before the corporate deals were done. The company changed its name to Arriva in January 2001. In April 2001, Arriva and Baxter said Arriva’s European patent on the use of AAT and other protease inhibitors was upheld in amended form. Bayer, Aventis SA and Genzyme Transgenics Corp. had filed oppositions.

With that behind it, Arriva has the clinical trials to focus on, as well as other indications to consider. Others besides Arriva are evaluating AAT in different areas, which Preuveneers said Arriva “may or may not take on.” But the financing, with lead investor MPM Capital LP, of Boston, and including AIG Global Investments, of New York, and CIBC Capital Partners, also of New York, speaks well for Arriva, Preuveneers said.

“We are very excited and pleased to have the investment from a premier league of investors,” he said. “They are in the top tier, as far as I’m concerned.”