Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.
PRNewswire - Monday November 27, 2000
"We are researching the potential for VX-175 to streamline protease inhibitor-based regimens, and we look forward to assessing the efficacy and safety of this drug in Phase III clinical trials," said Dr. Joshua Boger, Chairman, President, and CEO of Vertex. "Vertex and Glaxo Wellcome are committed to discovering and developing drugs that have the potential to offer improvements for HIV patients."
Two Pivotal Trials Now Underway
VX-175 is now being investigated in two Phase III clinical trials. Study 30001 is an open-label, randomized study that compares three tablets of VX-175 dosed twice daily with the protease inhibitor nelfinavir dosed twice daily in patients who have not previously received antiretroviral therapy. All patients will also receive the reverse transcriptase inhibitors abacavir and 3TC twice daily. This trial will enroll 210 patients at more than 30 centers in the United States, and will assess safety and antiviral efficacy of each regimen over a period of 48 weeks.
Study 30002 is an open-label study that will enroll more than 600 HIV- infected patients who have not previously received antiretroviral therapy. Patients will be randomized to receive either a combination of three tablets of VX-175 + ritonavir once daily, or 1250 mg nelfinavir twice daily. All patients will also receive abacavir and 3TC twice daily. The trial will be conducted at more than 50 research centers worldwide, and will assess safety and antiviral efficacy of each regimen over a period of 48 weeks. An additional Phase III study, in treatment-experienced patients, is planned for 2001.
VX-175 was discovered by scientists at Vertex Pharmaceuticals of Cambridge, MA and licensed to Glaxo Wellcome in the United States, Europe, and other countries. Glaxo Wellcome is responsible for product formulation and manufacture of VX-175, design and implementation of clinical trials, and regulatory submissions. Glaxo Wellcome holds the right to market VX-175 in the United States and the European Union, and Vertex retains co-promotion rights. Glaxo Wellcome is a research-based company whose people are committed to fighting disease by bringing innovative medicines and services to patients throughout the world and to healthcare providers who serve them.
About Vertex
Vertex Pharmaceuticals Incorporated discovers, develops and markets small molecule drugs that address major unmet medical needs. Vertex has 12 drug candidates in development to treat viral diseases, inflammation, cancer, autoimmune diseases and neurological disorders. Vertex has created its pipeline using a proprietary, information-intensive approach to drug design that integrates multiple technologies in biology, chemistry and biophysics, aimed at increasing the speed and success rate of drug discovery. Vertex's first approved product is an HIV protease inhibitor, which Vertex co-promotes with Glaxo Wellcome.
This press release contains forward-looking statements about Vertex and Glaxo Wellcome's drug candidate, VX-175, including statements about Glaxo Wellcome and Vertex's ability to develop and commercialize VX-175 successfully. While management makes its best efforts to be accurate in making forward-looking statements, any such statements are subject to risks and uncertainties that could cause Vertex's actual results to vary materially. Risk factors include uncertainties relating to the possibility of delays in clinical trials as a result of delays in patient enrollment among other things, the risk that clinical trials may not result in a marketable product, and the risk that Vertex and Glaxo Wellcome will be unable to secure regulatory approval of, or successfully market, VX-175.
Vertex's press releases are available at www.vrtx.com, or by fax-on-demand at (800) 758-5804 - Code: 938395.
SOURCE: Vertex Pharmaceuticals Incorporated
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