Travelers' vaccine in works Maryland company trying to develop diarrhea preventative

Biopharmaceuticals

November 07, 1997|By Mark Guidera | Mark Guidera,SUN STAFF

When the Centers for Disease Control and Prevention warned two weeks ago that a bacteria that is a leading cause of severe diarrhea and other intestinal distress is increasingly found in chicken products, the announcement received widespread news coverage.

But the CDC's alarm bells weren't news to V. M. "Vic" Esposito. The company he heads, Antex Biologics Inc. in Gaithersburg, is the only U.S. company attempting to develop a vaccine for the bacteria, Campylobacter.

The company's effort to develop a vaccine against the food-borne microbe, which is said to infect as much as 80 percent of the poultry raised in the United States, was launched three years ago.

"We have all along recognized that food-borne illnesses are a growing problem," said Esposito, Antex's president and chief executive officer.

"Campylobacter is definitely an emerging global disease, not just a problem in the U.S."

In fact, health experts believe Campylobacter to be the most common cause of diarrhea worldwide -- even more so than E.coli, the microbe found in beef, and Salmonella, another bacteria found in poultry.

Antex, which is developing treatments for infectious bacterial diseases, sees the largest potential market for the vaccine, if it is fully developed and approved by the Food and Drug Administration, among the estimated 35 million U.S. citizens who travel internationally annually.

"We are developing this as a travelers' vaccine. Conceivably, you could also carry it with you as a booster," said Esposito. The vaccine for Hepatitis A, another serious food-borne illness, is largely sold to the same traveling market.

Dr. Dennis Lang, program officer for enteric diseases at the National Institute for Allergy and Infectious Diseases and a food-borne-disease expert, said vaccines against emerging food-borne diseases, such as Campylobacter, Salmonella and E.coli, are badly needed.

The reason: While most people who get sick from the bugs respond well to good antibiotic treatments, serious and sometimes life-threatening complications are triggered in others.

For example, said Lang, Campylobacter can trigger Guillain-Barre syndrome, which can lead to paralysis of the lungs. Those affected must be put on respirators until the reaction clears.

However, commercial interest in developing such vaccines for people is thin, Lang said. The reason: A big hurdle faced by companies working on vaccines against food-borne diseases is convincing the most lucrative potential market -- Americans who travel -- that they should get the vaccine.

"That's where the government's role in funding research and clinical trials is so critical," Lang said. "Without that support, there may not be interest in some of these vaccines."

His office has an active vaccine research program for a number of food-borne diseases, including Salmonella and Campylobacter. Other government agencies also are funding food-borne disease research; the Navy is financially supporting some of Antex's research.

Antex, which has no approved products, declined to disclose specific estimates of the potential market value of the vaccine. But it could be a multimillion-dollar revenue generator if ever approved by the FDA, said Esposito.

One potentially significant market for the vaccine would be U.S. and foreign military outfits, said Esposito. Public health services in developing countries are another potential market.

The CDC estimates that as many as 2 million people in the United States are infected with the bug annually and get sick. But world health officials estimate that as many as 400 million worldwide, primarily in developing countries, come down with illnesses from Campylobacter.

Handling raw poultry or eating undercooked chicken is a culprit for transmission, but the pathogen is also found in unclean water and unpasteurized milk.

To ensure that the vaccine generates strong interest among physicians and the potentially lucrative travelers' market in the United States, the company is working to produce it in tablet or capsule form, said Theresa M. Stevens, vice president for corporate development. The pill form would not only make the vaccine easy to use, but make it very potable for booster use, and potentially lower its cost, she said.

Drug giant SmithKline Beecham has licensed the rights to market the Campylobacter vaccine if it is successfully developed.

As part of the joint venture, the company has pledged $30 million to assist Antex with research and development on the vaccine.

The vaccine is being studied in a human trial conducted by the Army and Navy at Fort Detrick near Frederick.

Antex hopes to see a pivotal large-scale human trial on the vaccine launched next year. It would take about two more years to get the FDA to consider the vaccine.

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