Washington Editor

WASHINGTON - The federal government continues to stress the need for cooperation in moving the fight against avian influenza forward, and two news items in and around here Monday underscored that theme.

At the same time that national public health figures met with state and local officials on bird flu preparations, Cel-Sci Corp. agreed to let federal government researchers evaluate one of its investigational anti-infective drugs. That sparked a 19 percent jump in the company's shares, (AMEX:CVM), which gained 10 cents to close at 62 cents.

Cel-Sci, based in the Washington suburb of Vienna, Va., signed a cooperative agreement with the National Institute of Allergy and Infectious Diseases to test CEL-1000 against the H5N1 virus in animal models to determine whether the product could be used as a potential treatment and/or preventive agent. Previous animal-challenge studies showed CEL-1000 to be protective against herpes simplex virus, viral encephalitis, malaria and other unpublished diseases, and to enhance survival against cancer in animals.

"It seems, in its most simplistic form, to be supercharging your immune response to more effectively deal with a disease when it's first presented," Cel-Sci CEO Geert Kersten told BioWorld Today, adding that a specific vaccine would be hard to build now, since "we don't even know what the thing is going to look like."

Therefore, he concluded, it could prove better to employ something with less specificity that could exhibit a more broad ability to work. CEL-1000 appeared to activate innate and Th1-type immune responses and induced a broad-spectrum protection against infection in those animal studies, some of which received previous government support.

"We have reason to believe that it is working on the innate immune system, most likely on a dendritic cell, or it could be CD4," said Daniel Zimmerman, Cel-Sci's senior vice president of research, cellular immunology. "We're still doing work on that to get more information as to which of the first events that are occurring after it does its initial binding reaction."

CEL-1000, derived from the beta chain of human MHC-II, is a modified version of a human immune-based protein known to bind to both human and mouse immune cells and appears to act by enhancing the host's protective immune response. It stems from a technology referred to as L.E.A.P.S. (Ligand Epitope Antigen Presentation System) to selectively stimulate the human immune system.

Future study details have yet to be worked out, Kersten said, but the groundwork has been laid for delivering the peptide to researchers at the NIAID, a part of the National Institutes of Health in Bethesda, Md.

Fostering the development of new drugs, vaccines and technologies has been a goal of federal health officials, who repeated that message to representatives from state and local agencies.

Armed with President Bush's proposed $7.1 billion pandemic flu preparedness plan these days, they also stressed the importance of cooperation among all levels of government, as well as the ability of federal, state and local officials to effectively communicate with the general population.

"The best government is within driving distance," Mike Leavitt, the secretary of the Department of Health and Human Services, told an audience of state and local officials.

Encouragingly for drug companies that have shied away from the vaccine space, he and others repeated calls for better incentives to stimulate more entrants into the market. For example, Leavitt and Anthony Fauci, the director of the NIAID, both emphasized the need to develop better production and dose-sparing technologies, but conceded that companies need better enticements to offset costs for developing such new manufacturing techniques.

So to establish market certainty, Leavitt said, all levels of government must work "to build a demand for the annual flu vaccine." Removing the yearly dilemma over supply worries also would eliminate concerns about a lack of surge capacity, with more modern production methods in place to solve both problems. He also voiced his support for drug companies' appeals for liability protection and regulatory improvements for inspecting manufacturing facilities that would be built domestically.

The one-day pandemic planning conference also included representatives from the White House Homeland Security Council, the Department of Homeland Security, the Agriculture Department, the Centers for Disease Control and Prevention and the National Vaccine Program Office.