Immune Response Corp. and Rhone-Poulenc Rorer have contributedanother $10 million to their joint effort to develop a drug aimed atpreventing or slowing the onset of AIDS in HIV-infected patients bystimulating their immune systems to fight the virus.Each contributed $5 million to Immunization Products Ltd., the jointventure formed in 1988 to develop the HIV immunotherapeuticvaccine. The companies have invested equally in the effort andfinancing now totals $55 million.The product, which has not been named officially, has completed PhaseII/III clinical trials. The companies are hoping to begin Phase III trialsby then end of this year and they are urging the FDA to qualify thedrug for accelerated review. A manufacturing facility in King ofPrussia, Pa., also is complete and awaiting licensing by the FDA.The joint venture has continued despite a dispute over management ofthe project between Immune Response, of Carlsbad, Calif., and Rhone-Poulenc, of Collegeville, Pa. The disagreement has focused on controlof the drug's development through clinical trials and regulatoryapproval.In June, Immune Response filed a petition in U. S. District Court inIllinois contending Rhone-Poulenc was violating a May 11 arbitrationruling giving Immune Response management rights over clinical andregulatory activities. No hearing date has been set.The arbitration was sought to resolve differences over interpretation ofthe 1988 agreement forming Immunization Products. The arbitratorruled that the agreement gave Immune Response control of researchand development and granted Rhone-Poulenc management ofmarketing and distribution.Manufacturing is to be shared through Immunization Products andsales revenues are to be split equally.Cindy Rollins, Immune Response's corporate communicationsassistant, said the management issue has not interfered with thedevelopment of the drug. Robert Partridge, Rhone-Poulenc's managerof product communications, agreed. He said the additional financing isfurther proof of the companies' commitments.Results of Phase II/III trials were released last year. The study of 103asymptomatic HIV-positive people was encouraging. The vaccineappeared to stabilize the decline of white blood cells (CD4 cells) thathelp the immune system fight the infection and slowed the virus' rateof increase in the blood. But the statistical results were consideredinconclusive.Details of the Phase III trial protocol have not yet been revealed.The drug, originally proposed by Jonas Salk, has been in clinical trialssince 1987 and has been judged safe. n
-- Charles Craig
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