Thursday June 19 8:03 AM EDT
Company Press Release
Source: Agouron Pharmaceuticals
Agouron Initiates U.S. Clinical Trial of Anti-Cancer MMP Inhibitor AG3340
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.
SOURCE: Agouron Pharmaceuticals
Contact: Donna Nichols, Senior Director of Corporate Communications for Agouron Pharmaceuticals, Inc., 619-622-3009, http: |
