Five biotechnology and pharmaceutical drug companies on both sidesof the Atlantic will join forces to strengthen the arsenal of weapons inthe ongoing battle against AIDS.
The Immune Response Co., of Carlsbad, Calif., Glaxo Wellcome plc,of Middlesex, U.K. and Merck & Co., of Whitehouse Station, N.J.,will collaborate on a Phase II trial using two antiviral drugs incombination with Remune, a type of immune-based therapy.
Hoffman-La Roche Ltd., of Basel, Switzerland, and AgouronPharmaceuticals Inc., of La Jolla, Calif., will combine two proteaseinhibitors with the goal of providing a potent and well-toleratedtreatment option.
Glaxo will provide zidovudine (AZT) and lamivudine (3TC) andMerck will provide its protease inhibitor crixivan (Indinavir) to beused for the Phase II trial. Both drugs will be used in conjunctionwith Remune, which is produced by Immune Response.
The 32-week trial will begin in January at sevenmedical centers in the U.S. and will involve 150 individuals withCD4 counts greater than 400. The study is a double-blind, placebo-controlled trial and will consist of three separate arms: Remune usedwith AZT, 3TC and Indinavir; Remune used alone; and AZT, 3TCand Indinavir used together.
The goal, said Chuck Cashion, chief financial officer of ImmuneResponse, is to determine whether the combination of Remune, AZT,3TC and Indinavir will act synergistically to lower the viral load,while simultaneously boosting the immune system.
"We believe that using Remune in combination with these antiviraldrugs will provide HIV-infected individuals with an expanded courseof therapy to treat the disease," said Dennis Carlo, CEO of ImmuneResponse. "The antiviral drugs attack the virus itself, while Remunestimulates the immune system to attach the cells which manufacturethe virus. The two forces, when combined, may be able to retarddisease process."
Remune is composed of inactivated HIV, depleted of its outerenvelope, and emulsified in Incomplete Freund's Adjuvant, an agentwhich elicits a more potent immune response by more effectivelypresenting the inactivated virus to the immune system. Remune isproduced through a culture of HIV-infected human T cells, purifiedfrom this cell culture and inactivated.
Hoffman-La Roche will provide its protease inhibitor Invirase, to beused in combination with Agouron's protease inhibitor Viracept, inthe European trials to begin at the end of the year. The study will takeplace in Belgium, France, Germany, the Netherlands, Switzerlandand the U.K.
One hundred fifty patients will be enrolled in four treatment arms:Invirase and nucleoside analogues (25 patients), Viracept andnucleoside analogues (25 patients), Invirase and Viracept withoutnucleoside analogues (50 patients) and Invirase and Viracept withnucleoside analogues (one of which is new to the patient, 50patients).
The study is slated to last 48 weeks after the last participant isenrolled.
Invirase has been cleared for marketing in both the U.S. and Europe.Viracept has yet to be approved. n
-- Frances Bishopp
(c) 1997 American Health Consultants. All rights reserved.