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| | | ![]() Preliminary Data Suggests Investigational Anti-HIV Compound Promising VANCOUVER, British Columbia, July 11, 1996 -- Glaxo Wellcome today issued the following: An investigational anti-HIV compound known as 1592U89 has a potentially significant effect on the markers of human immunodeficiency virus (HIV), according to preliminary data from a small phase I/II study presented today. The study, presented today at the XI International Conference on AIDS, evaluated the effects of multiple doses of 1592U89 given alone for four weeks, followed by eight weeks in combination with either Retrovir(R) (zidovudine; AZT) or a placebo. The study enrolled approximately 80 patients who were followed for an additional four weeks after termination of therapy. 1592U89 is a nucleoside analogue reverse transcriptase inhibitor. At four weeks, treatment with 1592U89 (200 mg or 400 mg three times daily) resulted in a 1.5 to 2.2 log (nearly 99 percent) decrease in the amount of HIV in the blood, and an average increase of 79 to 127 CD4 cells over baseline. Following eight more weeks of treatment in which patients received either 1592U89+AZT or 1592U89+placebo, the reductions in viral load and increases in CD4 cells were sustained. In this study, 1592U89 was generally well tolerated with the most commonly reported adverse events including nausea, headache, asthenia and rash. 1592U89 was discovered and is being developed by Glaxo Wellcome. "While we are encouraged by these data, we also realize that they are very early and in small numbers of patients," said Richard Kent, M.D., vice president and director of worldwide clinical research for Glaxo Wellcome. "There is much we need to learn about optimal dosing of the compound, its potential synergy with other antiretrovirals, and its tolerability profile before we can draw any conclusions regarding its ultimate role in therapy." Glaxo Wellcome is the industry leader in developing therapies for HIV infection and AIDS. In 1987, Retrovir became the first drug released by the FDA for use in treating HIV and AIDS. Eight months ago, Epivir(R) (lamivudine; 3TC) was released by the FDA under accelerated approval regulations for use in combination with Retrovir for the treatment of HIV and AIDS. In addition, Glaxo Wellcome discovered, developed and markets several products for the treatment of HIV-related opportunistic infections.
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