Responding to an NIH Advisory Panel’s Unanimous Vote to Recommend that the Department of Defense Proceed with Large Phase III Trials of a Potential AIDS Vaccine, Franklin Volvovitz...

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-MicroGeneSys, Inc..... 8IOPHARMACEUTICALS
o, 1Q00 Research Parkways Meriden, CT 06450-7159"USA...,--Telephone: [phone]aFacsimile: [phone]
BETHESDA, Maryland, November 23 --Responding to an NIH advisory panel's
unanimous vote to recommend that the Department of Defense proceed with large
phase IU trials of a potential AIDS vaccine, Franklin Volvovitz, Chairman and
President of MicroGeneSys, said he was "delighted" with the decision. The
principal drug to be tested, gpl60, is made by MicroGeneSys under the name
VaxSyn.
Volvovitz acknowledged the pioneering research of Dr. Robert Redfield and
researchers in the U. S. Army who have been conducting comparative studies of
vaccine candidates for over two years. The NIH advisory panel on gpl60 heard
reports of data from Redfleld and others, and decided to recommend continuation
and expansion of the drug trials.
Volvovitz emphasized the Importance of caution In the design of clinical protocols
for Inclusion of other vaccines In the trials. "The success to date of gpl60 should
be the focus of continued research because it is farthest along the development
path, and because of its proven safety and compelling data on immunogenicity
and CD4 cells." Unless additional funding is available to enlarge the study
endorsed by the NIH advisory panel, Inclusion of other vaccines will dilute the
power of the study to arrive at a definitive answer. "We don't want to be back
here scratching our heads and wondering about the data two years from now,"
according to Volvovttz.
"The scientific process worked," Volvovltz added, "and NIH should be proud of
its decision."
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