Monday, March 4, 1996
By Karen Bernstein
Genentech Inc.'s plans for a spinoff, Genenvax Inc., to run Phase III trials of its gp120 AIDS vaccine, has sparked dissent in certain quarters of the clinical research community.
GNE last month announced that it plans to invest $2 million in the new company, which hopes to raise $18 million from private investors, in order to run studies in the U.S. and Thailand (see BioCentury, Feb. 26).
Last week, in response to comments made in BioCentury by Genevax Chairman Robert Nowinski, two AIDS researchers challenged the potential clinical value of the GNE vaccine.
John Moore, a staff scientist at the Aaron Diamond AIDS Research Center in New York, noted that the NIH had decided to drop development of both gp120 HIV vaccines from GNE and Chiron Corp. Moore, who is part of the CHIP group - Correlates of HIV Immune Protection - that has been analyzing trial participants who have been infected with the virus, said NIH had made the correct decision.
Although Moore specifically declined to characterize the efficacy of the vaccines in trials to date, he provided data showing the occurrence of breakthrough infections in two studies.
According to Moore, a total of 596 individuals from both high and low risk groups have been treated in Phase II studies with both vaccines, including 276 given GNE's MN-gp120 vaccine, 234 who received CHIR's SF2-gp120 vaccine and 86 placebo recipients. He said there were 19 breakthrough infections, including 10 in the MN