Biotech firm plans to test vaccine on humans by year's end.

2003 APR 2 - (NewsRx.com & NewsRx.net) -- A San Diego biotechnology firm says it hopes to begin human testing of its experimental anthrax vaccine by year's end.

Several companies and government researchers are racing to create a better anthrax vaccine than the one now available and manufactured by BioPort, Inc. of Lansing, Michigan.

Vical, Inc. executives presented data March 10, 2003, that showed their novel DNA vaccine protected rabbits that inhaled anthrax with little side effect, building upon their successful work with mice. Now the company hopes to convince the U.S. Food and Drug Administration (FDA) to allow it to test the two-injection regimen on a handful of people to prove the vaccine is safe.

It is highly unethical to purposely expose experiment volunteers to diseases like anthrax. So the FDA said it will approve some vaccines that protect at least two different animal species and prove safe in human experiments.

Vical head Vijay Samant said company executives and FDA officials are still discussing if the rabbit and mice data are strong enough to support human experiments or if tests on monkeys will be required first. An FDA spokeswoman declined to comment on the talks.

Vical's vaccine is created with genetic material of the anthrax bacterium that codes for two of the disease's telltale proteins. The vaccine provokes a mild immune response and primes the body to defend against a more virulent ...