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FDA clears IND for an attenuated smallpox vaccine candidate.
2004 OCT 6 - (NewsRx.com & NewsRx.net) -- VaxGen, Inc., (VXGN.PK) announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for the company's candidate smallpox vaccine, LC16m8.
The effective IND will allow VaxGen to begin clinical development of LC16m8 with the objective of meeting the U.S. government's stated interest in acquiring an emergency stockpile of an attenuated smallpox vaccine and licensing the product for commercial sales. The U.S. government has indicated that it anticipates spending $1.9 billion to establish and maintain a stockpile of attenuated smallpox vaccine over a 10-year period.
The IND clears the way for a phase I/II human clinical trial to evaluate the safety and immunogenicity of LC16m8 and compare it to Dryvax, the smallpox vaccine currently licensed for use in the United States. The trial is expected to begin before the end of this year. It will involve approximately 150 volunteers at 4 leading medical centers: Saint Louis University Health Sciences Center, Stanford University, University of Kentucky, and Vanderbilt University Medical Center.
"LC16m8 was extensively evaluated during its development in ...
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Source: HighBeam Research, FDA clears IND for an attenuated smallpox vaccine candidate.