By Lisa Seachrist
Just one month after starting a Phase III trial testing Remune's ability to induce T cell responses to HIV infection, the researchers conducting the trial have stopped the trial to tweak the protocol.
Remune's developers - The Immune Response Corp. (IRC) and Agouron Pharmaceuticals Inc. - announced the study had been halted by the AIDS Clinical Trials Group (ACTG) to reassess the protocol design. Since May, the study has enrolled 131 patients who will continue on the trial therapy until the new protocol can be put into place.
"We don't really know much right now," said Joy Schmitt, spokeswoman for La Jolla, Calif.-based Agouron, a wholly owned subsidiary of Warner-Lambert Co., of Morris Plains, N.J. "The protocol team has only told us the trial was halted. They did emphasize, however, that there were no safety issues."
Amendments to the protocol often occur when investigators believe there's a need to change the number of patients involved or the length of the trial, Schmitt said. While the companies don't know why the study was stopped, Schmitt said the ACTG noted the study protocol is expected to be developed quickly.
Remune is an inactivated form of HIV lacking its envelope. It is combined with a mineral oil-based adjuvant and is designed to stimulate a patient's own immune defenses to keep the virus in check.
The Phase III study started last month was to test whether Remune added to highly active antiretroviral therapy (HAART) can prolong the durability of these therapies. The trial was designed to enroll patients who had achieved a stable regimen of HAART and test whether Remune could prolong the effectiveness of that regimen.
The study as originally designed was to enroll 472 patients and last for 96 weeks. Those parameters could change following the decision of the ACTG study protocol team.
Agouron and Carlsbad, Calif.-based IRC signed a $77 million pact to develop Remune six months before Agouron was acquired by Warner-Lambert in a $2.1 billion deal. (See BioWorld Today, June 12, 1998, p. 1, and Jan. 27, 1999, p.1)
In other news, Agouron launched a collaboration with PPD Discovery, a wholly owned subsidiary of PPD Inc., to identify new targets for selectively eradicating cancer cells. The deal focuses on the discovery and validation of novel drug targets that control survival of cancer cells, and will use PPD Discovery's GSX System functional genomics platform.
The companies will be searching for genetic suppressor elements (GSEs) capable of inducing programmed cell death.
Financial terms were undisclosed, but the deal will include up-front, research and milestone payments to PPD Discovery's Menlo Park, Calif.-based genomics facility. A PPD spokesperson said if one product is approved for sale, the value for PPD could exceed $30 million.
IRC's stock (NASDAQ:IMNR) closed Friday at $7.719 down 78.12 cents. PPD's stock (NASDAQ:PPDI) closed at $18.125, up 25 cents.