Agouron and Immune Response to Commercialize Remune (TM) Immune-Based Treatment
On June 11 Agouron Pharmaceuticals, Inc. and The Immune Response Corporation announced that they have agreed to collaborate on the final development and commercialization of Remune, an immune-based treatment for HIV.Remune is the HIV treatment vaccine developed by the late Dr. Jonas Salk. It is currently in a phase III trial in which 2500 patients were randomized to receive the treatment or not once every three months--in addition to standard antiretroviral therapy. The trial finished enrollment in May 1997, and is expected to be completed in April 1999.
Immune-based treatments have been difficult to test, because there is no surrogate marker (like viral load for antiretrovirals) which is well-established for quickly telling if a drug is working, and predicting long-term clinical benefit. Without a surrogate marker, trials must wait for "clinical endpoints"--persons becoming ill--to see if those with the new treatment do better than those without it. That is why a Remune trial with 2,500 volunteers is now being conducted.
Agouron decided to get involved after reviewing the data available, including "encouraging preliminary results from a small study of Remune taken in combination with highly active antiretroviral drugs--results that will be presented at the upcoming 12th World AIDS Conference in Geneva later this month" (Agouron press release, June 11; the reference is to a report to be presented by Fred Valentine, M.D., of New York University).
