The reason the price went down was because of the Vertex announcement.
Wednesday February 19 9:27 AM EDT
Phase III Pivotal Clinical Trial Begins with
141W94/VX-478, a Protease Inhibitor Designed by Vertex
for Treatment of HIV Infection and AIDS
CAMBRIDGE, Mass., Feb. 19 /PRNewswire/ -- Vertex Pharmaceuticals Inc announced today
that its partner, Glaxo Wellcome, has begun a Phase III pivotal clinical trial with 141W94/VX-478
for the treatment of HIV infection and AIDS in adults. A Phase III pivotal clinical trial in children is
expected to begin in the coming weeks. The pivotal trials, as well as advanced clinical studies
underway or planned by Glaxo Wellcome, are intended to support filing for market approval of
141/VX-478 in the United States and other countries. 141/VX-478 is a second generation HIV
protease inhibitor being developed by Glaxo Wellcome plc, Kissei Pharmaceutical Co., Ltd., and
Vertex Pharmaceuticals.
"The Phase III pivotal clinical trial as well as extensive Phase II studies combining 141/VX-478 with
a variety of established and investigational antiviral therapies should generate important clinical data,"
commented Dr. Joshua Boger, President and CEO of Vertex. "This information should enable us to
define the tolerability and efficacy profile of 141/VX-478 across a diverse patient base."
Glaxo Wellcome's double-blind, placebo-controlled Phase III pivotal clinical trial is designed to
evaluate the tolerability, antiviral efficacy, and durability of antiviral response of the triple
combination of 141/VX-478, AZT and 3TC compared to the double combination of AZT and
3TC. Entry requirements for the study are antiretroviral naive patients with CD4+ counts greater
than 200 mm3, and HIV RNA counts greater than 10,000 copies/mL. The study is expected to
enroll approximately 240 HIV-positive adults, and will be conducted at approximately 30 clinical
trial sites in the United States, Canada and Europe.
Through a series of advanced clinical studies underway or planned by Glaxo Wellcome, the use of
141/VX-478 is being assessed in a wide array of clinical trials for the treatment of HIV infection
and AIDS. Phase II trials underway are evaluating regimens combining 141/VX-478 with AZT,
3TC and 1592U89, as well as with other HIV protease inhibitors. In February 1997, a 24-week
Phase II clinical trial of 141/VX-478 as a single agent was initiated in collaboration with the AIDS
Clinical Trial Group, a cooperative supported by the National Institute of Allergy and Infectious
Diseases.
In January 1997, at the 4th Conference on Retroviruses and Opportunistic Infections held in
Washington, DC, preliminary data from a small four-week study were presented which suggested
that 141/VX-478 may have potent antiviral activity as a single agent and in combination with
1592U89. At the same meeting, preliminary data were presented from the Phase I/II clinical trial
derived from genotypic (sequence) and phenotypic (drug sensitivity) analyses, which suggested that
resistance did not develop to 141/VX-478 administered as a single agent over four weeks.
Vertex Pharmaceuticals Incorporated is engaged in the discovery, development and
commercialization of novel, small molecule pharmaceuticals for the treatment of diseases for which
there are currently limited or no effective treatments. The Company is a leader in the use of
structure-based drug design, an approach to drug discovery that integrates advanced biology,
biophysics and chemistry. The Company is concentrating on the discovery and development of
drugs for the treatment of viral diseases, multidrug resistance in cancer, hemoglobin disorders,
inflammation, autoimmune diseases, organ transplant rejection, and neurodegenerative diseases.
Epivir and 3TC (lamivudine) and Retrovir and AZT (zidovudine) are trademarks of the Glaxo
Wellcome Group of Companies. SOURCE Vertex Pharmaceuticals Incorporated
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