Transave Inc. raised $12 million in a Series B financing round, funds intended to help the company move forward its technology and products in the area of therapies for lung diseases.

"Our management has probably 75 years of combined pharmaceutical and biotech experience, and we've developed a number of commercial products," Transave President, CEO and founder Frank Pilkiewicz told BioWorld Today. "What we're doing is very unique, so we're a low-risk investment."

He said the funds should last into 2005, well into clinical study stages of Transave's lead candidates. Since its 1997 inception, the Monmouth Junction, N.J.-based company has raised $15.75 million.

Transave plans to direct the latest funds toward Phase I and Phase II studies of its two lead inhaled products. The company aims to develop products to treat diseases that begin in the lung.

Transave's site-specific therapeutics focus on lung diseases that include cancer and infectious diseases. The early product candidates, reformulated versions of already approved drugs, were developed in an updated form through its SLIT (sustained-release lipid inhalation targeting) technology.

"This technology lets us keep things in the lung and target it to the site of the disease," Pilkiewicz said. "Doing that, we can take a variety of products that are normally used to treat lung disease by injection or oral delivery, and give you a site-specific treatment."

Drugs reformulated through the SLIT technology are designed to work as improved versions of their current injectable, inhaleable or oral versions.

Transave said its technology provides prolonged therapy and targets a drug's uptake into diseased cells, while reducing local and systemic toxicity. Also, Transave said such a sustained release requires lower overall doses of a drug, potentially reducing the downstream effect of resistance.

"You can take a product you normally get by injection, and very little would get to the lung," Pilkiewicz said. "I'll give you a way in which you'd give a lot less, deliver it to the lung, and keep it there. And I also give you a way to target it to a disease site."

He said the first applications of Transave's technology involve restructured injectable small molecules. Preclinical work is under way, with clinical studies in lung cancer and pulmonary Gram-negative infected patients scheduled to begin early next year.

The 14-employee company has remained relatively stable since its outset as an early stage firm awaiting patents. But with Transave's lead products now on the cusp of clinical trials, the company appears poised for growth.

Pilkiewicz said Transave finds itself in a position to choose whether to continue internal development or look for collaborative partnerships.

"We have the ability to develop the products ourselves since they are already approved, and we've developed safer, more effective versions of them," Pilkiewicz said. "But this also could attract the attention of partners."

He added that the technology itself also could prove valuable to an outside partner, as it enables reformulations not only of small molecules, but also of larger molecules and gene vectors.

"The technology is very applicable to classic pharmaceuticals, as well as the peptides, proteins and genes of tomorrow," Pilkiewicz said. "It could be very attractive to someone who has developed a chemical entity or a biological that would be used to treat a lung disease, whether it be cystic fibrosis, a Gram-negative infection, a lung cancer, asthma or emphysema, if they don't have a viable way of giving the drug."

New York-based Easton Hunt Capital Partners and ABN AMRO Capital, of Amsterdam, the Netherlands, led the round. Other investors included Series A leader Techno Venture Management, of Boston; Sycamore Ventures, of Princeton, N.J.; CDIB Bioscience, of Taiwan; and Musket Research Associates, also of Boston. Concurrent with the financing, Transave appointed a pair of investor representatives to its board - John Friedman, Easton's managing partner, and Geert-Jan Mulder, AMRO's director.