LA JOLLA, Calif., June 19 /PRNewswire/ -- Agouron Pharmaceuticals, Inc.,
(Nasdaq-NNM: AGPH) today announced that it has received clearance by the
United States Food and Drug Administration (FDA) to commence clinical studies
of its anti-cancer agent AG3340 in the United States.
    Under an Investigational New Drug Application (IND) submitted to FDA in
May 1997, the University of Wisconsin Comprehensive Cancer Center in Madison,
Wisconsin and The Vanderbilt Clinic at Vanderbilt University in Nashville,
Tennessee will proceed to conduct extended, dose-escalation studies of AG3340
in patients with advanced cancer.  Completion of this initial U.S. study will
position Agouron and Roche to investigate the safety and anti-cancer activity
of AG3340 in longer term clinical trials.
    Earlier this year, Agouron reported encouraging results achieved in a
phase I study of AG3340 carried out in Edinburgh, Scotland.  In this study,
healthy male volunteers received single doses of AG3340 between 10 mg and 200
mg in tablet form.  The purpose was to evaluate the tolerability of the drug
and to determine whether adequate blood concentrations could be achieved
following oral administration.  AG3340 was well tolerated at all dose levels
studied.  AG3340 was rapidly absorbed following oral administration.
Sustained blood concentrations were observed that were substantially greater
than those showing efficacy in animal cancer models.
    AG3340 is a small, synthetic molecule designed to selectively inactivate
certain members of a family of enzymes known as matrix metalloproteases
(MMPs).  Some MMPs, such as gelatinases, stromelysins and collagenase-3, are
believed to play key roles in the invasion, metastasis and growth of many
malignant tumors.  Other MMPs, such as matrilysin and interstitial
collagenase, are believed to be involved in normal adult biological processes,
including collagen turnover and endometrial cycling.  AG3340 selectively
inhibits those MMPs believed to be required for tumor progression, but is
relatively inactive against other MMPs involved in normal biological
processes.  A primary goal of clinical studies of AG3340 is to determine
whether its distinctive selectivity results in a uniquely favorable profile of
safety and efficacy.
    AG3340 was originally designed by Agouron in collaboration with scientists
from Syntex (U.S.A.) Inc., now a member of the Roche Group.  AG3340 is
currently being developed jointly by Agouron and Hoffmann-La Roche Inc.  Under
terms of the collaboration, Roche will assume 80% of development costs of
AG3340 and will lead commercialization of the drug outside of North America
with payment of royalties to Agouron.  Roche and Agouron will co-promote
AG3340 in North America and will share equally in profits derived from North
American sales of the drug.
    Agouron Pharmaceuticals, Inc. is an integrated pharmaceutical firm
committed to the discovery, development, manufacturing and marketing of small
molecule drugs engineered to inactivate proteins which play key roles in
cancer, AIDS, and other serious diseases.

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