Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.

Reuters NewMedia - Monday May 17, 1999
Ransdell Pierson

Earlier Monday, the company said an independent data safety monitoring board advised ending a Phase III trial evaluating the benefit of adding Remune to conventional anti-HIV therapies such as cocktails of protease inhibitors and reverse transcriptase inhibitors (RTIs).

The Carlsbad, Calif., company said the panel advised that the 2,500-patient trial be scrapped because differences in clinical "endpoints", or outcomes, were not seen in patients who added Remune to their conventional therapies and those not adding Remune.

Immune Response said the number of people progressing to AIDS or dying in both groups was far less than expected because many participants began taking the new life-saving protease inhibitors and RTIs after the trial was initiated several years ago.

However, the company said studies of a subset of 250 of the patients showed that those taking Remune did appear to benefit in other ways, although they did not have fewer deaths or less progression to disease.

Specifically, Immune Response said the subset group had greater reduction of HIV virus levels and greater increases of virus-fighting lymphocytes in their bloodstream after up to 96 weeks of treatment.

Based on positive results in the subset group of patients, Immune Response said it and development partner Agouron Pharmaceuticals (Nasdaq:AGPH - news) would begin two new Phase III studies of Remune using viral load and lymphocyte levels as endpoints upon which success of the new trials would hinge.

OrbiMed Advisors drug analyst Michael Sheffery said Immune Response's shares were pounded because it will take at least 18 months to design and complete the new Phase III trials -- a delay that will push back possible commercialization of Remune to 2002.

Sheffery said Immune Response spends about $25 million more each year than it takes in from revenues. With about $28 million in cash on hand, he said the company would therefore run out of money within about a year unless it manages to cut costs and/or seeks private financing.

"Remune is Immune Response's lead product so a delay in getting to market will put them in a hard place. It gives them a real cash problem," Sheffery said. Sheffery said Remune consists of HIV viruses that are killed by radiation and stripped of their outside coating. The hope is that proteins from the core of the killed virus will awaken the immune systems of patients already infected with HIV.

He estimated the vaccine might generate annual revenues of $300 million to $500 million if it ultimately proves effective in bettering patient outcomes and is approved by U.S. regulators.

Agouron is scheduled to be acquired Monday by Warner- Lambert Co. (NYSE:WLA - news), which will continue with Remune co-development.

Agouron, cushioned by substantial revenues from already marketed drugs such as the anti-HIV protease inhibitor Viracept, rose 37 cents to $59.44 on the Nasdaq.
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