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Agouron's
AG3340
Angiogenesis Inhibitor
in Trials
May 7 '98. An experimental oral drug for cutting blood supply
to tumors will be tested in Phase II/III clinical trials including patients
with prostate cancer. This round of trials for the anti-cancer drug AG3340
was announced by the biotech company Agouron Pharmaceuticals Inc.
AG3340 is defined as a matrix metalloprotease
inhibitor. In mice, the company says, the drug inhibits angiogenesis (formation
of new blood vessels which feed growing tumors). The drug appears to enhance
anti-tumor activity of certain conventional chemotherapy agents.
The clinical studies of AG3340 are designed to
find out whether this drug is safe and effective for prostate cancer patients
and lung cancer patients.
The company says Phase I clinical studies have
shown that patients are able to tolerate AG3340 at doses which will be
given in the upcoming trials. This means that the investigators, regulated
by the Food and Drug Administration, believe the drug is safe to test
further. Whether it has therapeutic value for men with prostate cancer
and if so at what dose is not yet known.
The Phase III trials will recruit patients with
advanced hormone-refractory prostate cancer. Patients in the active arm
will receive AG3340 in tablet form in combination with Novantrone(R) (mitoxantrone)
and prednisone.
The main aim of the AG3340 study is to find out
if the drug can slow progression of the disease. The investigators will
also be looking to see how many patients respond, how long the patients
survive, what effect the drug has on the patients' quality of life and
how all of these results compare with those of standard therapies.
Recently a cancer drug developed and tested by
Agouron was "discontinued .... on the basis of ... interim analysis
of results from phase II/III trials..." (See panel below, Quarterly
Report).
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Set-Up For Trials
In Phase II trials investigators test for therapeutic dose-level
and for efficacy. Cohorts (groups) of patients enter the trial at
escalating dose levels. Blood tests, MRI or CAT scans and bone scans
are taken at intervals.
Phase III trials require double-blind randomization.
Patients are assigned (typically, by a computer) either to the active
treatment arm, delivering experimental therapy, or to an arm delivering
standard therapy or placebo. Investigators, physicians, nurses,
and patients themselves are not told which group is which.
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AG3340 is a synthetic molecule designed
to inhibit growth, invasion and metastasis of solid tumors. The aim is
to do this by "inactivating certain members of a family of enzymes
known as matrix metalloproteases (MMPs)," the company says. AG3340
picks out and inhibits those MMPs believed to help tumors grow.
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Quarterly Report
"In December 1997, the Company discontinued further development
of its anti-cancer drug AG337 (Thymitaq (tm), nolatrexed dihydrochloride)
on the basis of its interim analysis of results from phase II/III
trials of the drug and in order to concentrate available resources
on the development of two earlier-stage anti-cancer agents that
the Company believes have greater commercial potential. The Company
believes that the termination of the THYMITAQ development program
will not have a significant impact on current year operating results."
Excerpt from April 14, 1998 Agouron Pharmaceuticals
Inc (AGPH) Quarterly
Report (SEC form 10-Q) "Management's Discussion and Analysis
of Financial Condition and Results of Operations"
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Announcement of Phase II/III trials for AG3340
came on the heels of intense excitement following a New
York Times article on the anti-angiogenesis agents endostatin
and angiostatin. Two weeks previously, following the April
14 Quarterly Report, Agouron's stock had been downgraded from
"strong buy" to "outperform." Yahoo
Message Board about Agouron discusses future prospects
of the company.
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Agouron Pharmaceuticals Inc is a biotech company making
drugs for AIDS, cancer, and other serious diseases. Agouron makes Viracept
(nelfinavir mesylate), a protease inhibitor for the treatment of HIV infection.
May 7, modified August 10, December 26, 1998
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©1998-1999
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