Biosynexus Inc. was created in 1999 to develop drugs to prevent and treat hospital-acquired infections, an area its CEO said is growing as more and more nosocomial infections have become resistant to existing antibiotics.

The privately held company was born as a spin-off of Virion Systems Inc., of Rockville, Md., and Sunol Molecular Corp., of Miramar, Fla. Gerry Fischer was named the new company's founding CEO and president.

Rockville, Md.-based Biosynexus today has three protein-based platforms: monoclonal antibodies, enzymes and peptides.

"At this point, we are focusing on bacterial infections," Fischer said.

Fischer was president and CEO at Virion before leaving to take the helm of Biosynexus to attempt to develop drugs to fight infections. For example, the company said that the annual market for Staphylococcus infections in neonates is $500 million in the United States.

Biosynexus' lead drug candidate is BSYX-A110, a chimeric anti-lipoteichoic acid antibody that initially is being developed to prevent coagulase-negative staph infections in premature infants. The antibody is in Phase I/II trials in neonatal patients to prevent neonatal staphylococcal infections. The company had successfully completed a Phase I trial in adult patients, a study that met the primary endpoints of safety and tolerability. It also produced opsonic activity, which translates into a high level of potency, Fischer said.

The Phase I trial was an open-label, dosing-ranging study involving eight healthy patients who were divided into two dosage groups.

Preclinical studies showed that the antibody provided protection in what the company called "highly lethal" animal models.

In the enzyme area, Biosynexus has lysostaphin, an intranasal cream to fight staph infections that have colonized in the nose. That product is in Phase I trials. In December 2000, AMBI Inc., of Purchase, N.Y. - now Nutrition 21 - licensed rights to nisin and lysostaphin antibacterial technologies to Biosynexus.

Biosynexus' peptide platform is still in the preclinical phase, Fischer said.

The company has raised about $25 million to date, and Fischer said that has provided sufficient funds to continue clinical trials of its lead product.

Privately held Biosynexus now has 35 employees, but that number may grow, especially in the clinical area.

Biosynexus is evaluating whether or not to partner BSYX-A110, Fischer said. The company is in conversations with pharmaceutical companies, and Fischer said he anticipates that the company would partner in the areas of manufacturing of monoclonal antibodies and in co-promotion and co-sales.

"At this time we're evaluating a number of scenarios," he said.

In the short term, the monoclonal antibody Phase I/II trial of BSYX-A110 will continue over the next year.

"We're very excited to be able to move a product forward in this area of great need," Fischer said.