European Phase II/III study indicates sustained effect of 3TC in combination with AZT on surrogate markers of HIV for two years.LAVAL, QUEBEC, Canada--(BUSINESS WIRE)--Sept. 29, 1995--BioChem Pharma Inc. announced that follow-on results from the European Phase II/III clinical study (NUCB NUCB Nagoya University of Commerce Business 3001) of 3TC(TM) (lamivudine) in combination with zidovudine zidovudine /zi·do·vu·dine/ (zi-do´vu-den) a synthetic nucleoside (thymidine) analogue that inhibits replication of some retroviruses, including the human immunodeficiency virus; used in the treatment of HIV infection and AIDS. (Retrovir(R)/AZT) were presented today at the 5th European Conference on Clinical Aspects and Treatment of HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. Infection in Copenhagen, Denmark. The study, begun more than two years ago, involved 129 patients and was first reported in November 1994. Data presented today by Dr. Christine Katlama of the Hopital Pitie-Salpetriere, Paris, indicated that the effects of the 3TC(TM)/AZT combination, as measured using the surrogate markers CD4 cell CD4 cell CD4+ lymphocyte A circulating T cell with a 'helper' phenotype; in AIDS Pts, the levels of CD4+ cells is a crude indicator of immune status and susceptibility to certain AIDS-related conditions; these Pts may suffer KS as CD4+ cells fall below 0. counts and viral load, were sustained for two years in the 26 patients for whom data is currently available. Submissions to seek regulatory approval for the use of 3TC(TM) in combination with AZT AZT or zidovudine (zīdō`vy  dēn'), drug used to treat patients infected with the human immunodeficiency virus (HIV), which causes AIDS; also called to treat HIV-infected adult and pediatric patients were filed internationally earlier this year, including in the U.S., Europe and Canada. 3TC(TM), an investigational new drug, was discovered by BioChem Pharma in 1989. Under the terms of the BioChem-Glaxo Wellcome license agreement, BioChem will receive a royalty based on sales and Glaxo Wellcome has the right to develop, manufacture and sell 3TC(TM) worldwide subject to special arrangements in North America. An equally owned joint venture will commercialize 3TC(TM) in Canada. In the United States, Glaxo Wellcome Inc. will be responsible for the commercialization of 3TC(TM) . As reported previously, Phase II/III study investigators considered the combination of 3TC(TM) and AZT to be well tolerated. The adverse events reported (nausea, abdominal discomfort, fatigue/malaise and headache) were generally characterized as mild with no statistical difference between treatment groups. Trials to assess the clinical benefit of 3TC(TM) in combination with AZT are underway as of April 1995 and are being conducted by Glaxo Wellcome. BioChem Pharma is an international biopharmaceutical company dedicated to the research, development and commercialization of innovative products for the detection, prevention and treatment of human diseases. The company's shares are traded on the Montreal and Toronto Stock exchanges (BCH BCH Beach BCH Banco Central de Honduras BCH Boot Console Handler BCH Boulder Community Hospital (Boulder, CO, USA) BCH Broadcast Channel BCH Belfast City Hospital BCH Banco Central-Hispano ) and on NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on (BCHXF). CONTACT: BioChem Pharma Inc. Christine Lennon Director, Investor Relations 514/978-7771 |
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