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2002 MAR 6 - (NewsRx.com & NewsRx.net) -- Epimmune Inc., (EPMN) provided an update on the status of its initial HIV vaccine candidate including clinical trial plans.
The company stated that, as additional time is necessary to complete all of the animal safety studies that were contemplated in its pre-IND discussions with the U.S. Food and Drug Administration, it anticipates filing an Investigational New Drug (IND) application for its initial vaccine candidate, a therapeutic HIV vaccine, during the second quarter of 2002. Clinical trials could begin approximately 1 month after filing the IND, pending FDA review.
The initial clinical trials, supported by an NIH grant which was recently increased by approximately $500,000, will be conducted at the University of Colorado Health Services Center under the direction of Constance Benson, MD, and Cara Wilson, MD, and will involve approximately 40 infected individuals on HAART therapy. Endpoints of the initial Phase I/II trial will be safety and immunogenicity.
"We continue to believe that our HIV vaccine approach is on the right track," said Mark Newman, PhD, Epimmune. "Epimmune studies, as well as recent results by others ...
Source: HighBeam Research, Epimmune provides HIV vaccine program update.(Brief Article)