VaxGen defends phase 2 anthrax trial results, claims facts distorted in article

By Elaine Rigoli

Tampa, Fla., March 17 - VaxGen, Inc. alleges that an article about the company's anthrax vaccine published in the Friday edition of The Washington Post mischaracterized phase 2 trial results.

The trial's objectives were to assess the safety and immunogenicity of a number of different formulations in order to identify the best one to be used in the final product, according to a company news release.

Although not all the objectives were met, the trial did confirm the strong safety and immunogenicity of the vaccine seen in the phase 1 trial. The phase 2 results and subsequent non-clinical investigations led to a better understanding of the vaccine formulation, the release said.

The Washington Post published a story Friday under the headline "No Hope for Stockpile of New Anthrax Vaccine by November." In the article, the Post said the government's $1 billion effort to develop a new anthrax vaccine has "run into difficulty" and that VaxGen had reported "failure in a major human test."

VaxGen said the phase 2 data showed an unexpected interaction between the vaccine's protein, rPA, and a standard Food and Drug Administration-approved adjuvant, aluminum hydroxide, used in other vaccines.

Using a new assay and a number of analytical tools, in 2005 the company said it began a large number of small-scale and large-scale formulation studies that enabled VaxGen to fully understand the properties and stability profile of the vaccine.

Based on the scientific data generated, VaxGen said it believes to have improved the vaccine by introducing changes to its formulation process.

"In regard to the anthrax contract, VaxGen continues to believe that the government is fully committed to purchasing 75 million doses of rPA102 at a total price of at least $877.5 million, as per the contract we were awarded in November 2004. As we have previously stated, discussions leading to an update to our contract are ongoing and will be announced when an amendment has been finalized," said Lance K. Gordon, president and chief executive officer, in a statement.

"We continue to estimate that we will have an anthrax vaccine available for delivery to the Department of Health and Human Services in the fourth quarter of 2006."

Based in Brisbane, Calif., VaxGen is a biopharmaceutical company engaged in the development, manufacture and commercialization of biologic products for the prevention and treatment of human infectious diseases, including anthrax, smallpox and Meningitis B.

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