Results of Two Phase 3 Studies of Investigational Prostate Cancer Drug in Early and Late-Stage Patients Announced at AUA
ANAHEIM, Calif., June 4, 2001 /PSA Rising/ - Amgen (NASDAQ: AMGN) and PRAECIS
PHARMACEUTICALS INCORPORATED (NASDAQ: PRCS) today announced data from two
phase 3 clinical trials that assess the ability of abarelix for injectable
suspension to reduce serum prostate specific antigen (PSA) levels and
testosterone levels compared with standard hormonal therapy. Both studies
also evaluated the frequency of hormonal "surge," an initial increase in
testosterone and other hormonal levels, at the start of therapy. The
results were presented at the annual meeting of the American Urological
Association.
Abarelix, a gonadotropin releasing hormone (GnRH) antagonist, is under
priority review by the U.S. Food and Drug Administration for the treatment
of prostate cancer.
In a head-to-head, randomized, multicenter phase 3 study (Zinner et al) of
271 patients with early and late-stage prostate cancer, those administered
abarelix (n=180) experienced a median percent reduction from baseline in
serum PSA of 50 percent after two weeks of treatment and 75 percent after
four weeks compared with a median percent reduction of 15 percent after
two weeks and 61 percent after four weeks for those treated with the
comparator, leuprolide acetate (n=91). At day 85, both patient groups had
achieved a greater than 90 percent reduction in serum PSA levels.
In measuring time to reduce testosterone to a targeted level (less than or
equal to 50 ng/dL), 72 percent of abarelix-treated patients achieved the
level by day eight compared with none of the leuprolide acetate-treated
patients. None of the abarelix patients experienced a surge of
testosterone compared with 82 percent of the leuprolide acetate patients.
On day two, patients treated with abarelix had median changes compared to
baseline of 84 percent reduction for testosterone, 80 percent reduction
for luteinizing hormone (LH) and 38 percent reduction for
follicle-stimulating hormone (FSH). Patients treated with leuprolide
acetate experienced a median change compared to baseline of 45 percent
increase for testosterone, 369 percent increase for LH and 100 percent
increase for FSH. From day 29 through day 85, both patient groups
achieved the targeted testosterone level.
"Testosterone fuels the growth of prostate cancer cells," said Dr. Norm
Zinner, a urologist at Western Clinical Research, Inc., in Torrance,
Calif. "A surge in testosterone may stimulate tumor cell growth, elevate
PSA levels and potentially worsen the symptoms of cancer during the first
weeks of treatment."
In a second head-to-head, randomized, multicenter phase 3 study (Pessis et
al) of 251 early and late-stage prostate cancer patients, 68 percent of
patients administered abarelix (n=168) achieved a reduction in
testosterone to a targeted level (less than or equal to 50 ng/dL) after
one week of therapy versus none of the patients administered a combination
of leuprolide acetate plus bicalutamide (n=83). All patients receiving
abarelix avoided testosterone surge compared with 14 percent of patients
receiving the combination. All patients in each treatment group achieved
a 50 percent reduction from baseline in serum PSA at 24 weeks.
In these clinical trials, the most frequently reported adverse events were
associated with physiological effects of lowered testosterone and included
hot flashes, breast enlargement, breast pain/nipple tenderness and
headache. The incidence of allergic events that required medical
intervention was similar in the active control and abarelix groups.
Measuring Testosterone, Pain and Other Symptoms in Advanced Metastatic
Disease
A separate single-arm study (Koch et al) evaluated 72 advanced
symptomatic prostate cancer patients with bone pain from skeletal
metastases (n=31), enlarged prostate gland or pelvic mass (n=25), urinary
tract obstruction (n=9), or impending neurological compromise (n=6). Of
these, 57 patients (79 percent) achieved a targeted level (less than or
equal to 50 ng/dL) of testosterone after one week on abarelix and 68
patients (94 percent) after four weeks. In addition, serum levels of PSA,
LH and FSH were suppressed from baseline levels throughout treatment. All
patients avoided surgical removal of the testicles through day 85.
This study also evaluated the level of pain and need for narcotic
analgesic use in 36 patients who had pain. The median Visual Analog Scale
(VAS) pain score, measured on a continuous scale of zero (no pain) to 10
(worse pain), declined from 4.4 at baseline to 0.7 on day 85. The
frequency, dose and/or potency of analgesic use decreased in 13 of the 19
patients using these medications at study entry.
Prostate cancer is the most common cancer (excluding skin cancer) in
American men. One out of 10 American men will develop the disease at some
point in his life, most after age 65. This year alone in the United
States, an estimated 198,100 new cases of prostate cancer will be
diagnosed and 31,500 men in this country will die of the disease. The
prostate is a small, walnut-shaped gland at the base of the male bladder
that secretes a major constituent of ejaculatory fluid.
Amgen is a global biotechnology company that discovers, develops,
manufactures and markets important human therapeutics based on advances in
cellular and molecular biology.
PRAECIS PHARMACEUTICALS INCORPORATED is a biotechnology company focused on
the discovery and development of pharmaceutical products using its
proprietary LEAP(tm) (Ligand Evolution to Active Pharmaceuticals)
technology.
This news release contains forward-looking statements that involve
significant risks and uncertainties, including those discussed below and
more fully described in the Securities and Exchange Commission reports
filed by Amgen, including the most recent Form 10-Q. Amgen conducts
research in the biotechnology/pharmaceutical field where movement from
concept to product is uncertain; consequently, there can be no guarantee
that any particular product candidate will be successful and become a
commercial product.
Furthermore, research, testing, pricing, marketing and other operations
are subject to extensive regulation by domestic and foreign government
regulatory authorities. In addition, sales of products are affected by
reimbursement policies imposed by third party payors, including
governments, private insurance plans and managed care providers. These
government regulations and reimbursement policies may affect the
development, usage and pricing of products.
In addition, while Amgen routinely obtains patents for products and
technology, the protection offered by patents and patent applications may
be challenged, invalidated or circumvented by competitors.
Because forward-looking statements involve risks and uncertainties, actual
results may differ materially from current results expected by Amgen.
Amgen is providing this information as of June 4 and does not plan to
update this information until its next press release and expressly
disclaims any duty to update information contained in this press release.
This news release contains forward-looking statements, these statements
are based on PRAECIS' current beliefs and expectations as to future
outcomes. Such statements are subject to certain factors and uncertainties
that may cause actual results to differ materially from expected results.
These include, but are not limited to, the timing and content of decisions
made by the United States Food and Drug Administration, fluctuations in
spending by corporate collaborators, delays in the development,
manufacturing, marketing or sale of potential products, unexpected
expenditures, unexpected results in ongoing and future clinical or
preclinical trials, the need for additional research and testing, and
access to capital and funding, as well as the risks set forth from time to
time in PRAECIS' filings with the Securities and Exchange Commission,
including but not limited to the risks discussed in PRAECIS' Annual Report
on Form 10-K for the year ended December 31, 2000 and its Form 10-Q, in
respect of the quarter ended March 31, 2001.
Amgen, www.amgen.com
NOTE: Data in this release correspond to AUA abstracts 850 (Zinner), 685
(Pessis) and 1185 (Koch).
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