Thursday, Jan 18, 1990
South San Francisco, Calif. -- January 18, 1990 --Genentech, Inc. today announced that it will concentrate the clinical research program for CD4-IgG, under contract from Genentech Clinical Partners IV (GCP IV), on studies aimed at preventing the spread of disease from human immunodeficiency virus (HIV)-infected pregnant women to their fetuses. GCP IV has no current plans to continue its clinical trials of CD4-IgG as a stand-alone therapy for HIV-infected adults. Genentech also will conduct further preclinical research directed toward improving understanding of the AIDS infection and developing CD4-based products for the treatment of HIV infections.
The decision, made by the GCP IV Board of Directors, was based on the results of several preclinical and Phase I clinical studies conducted with both CD4-IgG and soluble CD4, GCP IV's original product. Symptomatic HIV-positive patients who received CD4-based therapy in Phase I studies conducted to date have not shown consistent clinical improvements. Studies currently underway in this population will be completed soon.
Clinical trials to investigate the potential of CD4-IgG to prevent maternal-fetal transfer of HIV, including safety studies in young, HIV-infected infants, have begun. Previously published animal data confirming placental transfer of CD4-IgG supports further evaluation of CD4-IgG's potential to inhibit the transfer of HIV from a mother to her unborn child. Two Phase I studies in this patient group are expected to begin soon. The first, an extension of a multicenter pediatric study currently underway with CD4-IgG, will involve pregnant HIV-infected women. The second will be a single-center study aimed at evaluating higher doses of the agent in HIV-infected adults prior to testing pregnant women with these higher doses at a later date.
Genentech Clinical Partners IV is a limited partnership which was formed in June 1989 for the purpose of conducting activities related to the research, development, clinical testing, manufacturing and marketing of recombinant CD4 products as therapeutic agents for HIV. The partnership has contracted with Genentech, Inc. for the development of these potential products.
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