Larger Clinical Studies Are Assessing Use of NOVANTRONE in Prostate Cancer
Patients Urged to Call 303-315-5936 for More Details About Enrolling
In Clinical Study
SEATTLE, May 18 /PRNewswire/ -- A study of NOVANTRONE(R) (mitoxantrone for
injection concentrate) in hormone naive patients with prostate cancer who had
failed radiation or surgery, demonstrated that NOVANTRONE improved a standard
measure for prostate cancer, the prostate specific antigen (PSA) test. Data
were presented at the American Society of Clinical Oncology meeting in
San Francisco this week.
"I am encouraged by the improvement of PSA scores that NOVANTRONE has
elicited in these patients," said E. David Crawford, M.D., Professor of
Surgery and Radiation Oncology, University of Colorado, Denver, Colorado. "The
results of this study support the need for further evaluation of this new
approach to the treatment of hormone naive prostate cancer patients."
PSA is a protein produced by prostate cells. A small amount of PSA enters
the circulation, and its presence can be measured in the blood. The higher the
PSA level, the greater the chance that cancer is present and has spread beyond
the prostate.
In the study presented, 22 patients who had undergone radical
prostatectomy (removal of the prostate) or radiation therapy and failed
treatment as demonstrated by a PSA blood test, were treated with 10 mg/m2 of
NOVANTRONE initially, followed by a 12 mg/m2 dose every 21 days for a maximum
of eight cycles. A PSA blood test was then performed to determine if therapy
was effective.
The study demonstrated an average decrease in PSA of 42.5 percent after
six months of treatment. In addition, four of 22 patients experienced a PSA
decrease of greater than 50 percent. (The clinical significance of a fall in
PSA concentration after chemotherapy is unclear.) NOVANTRONE was generally
well-tolerated in this study. No grade 3 or 4 non-hematologic toxicity was
reported. Three patients had grade 3 or 4 neutropenia without fever.
"The improvement in PSA scores indicates that NOVANTRONE should be studied
further to see if it can control prostate cancer, in addition to reducing pain
associated with prostate cancer, for which it is already used in combination
with corticosteroids," said Richard Stead, M.D., Immunex vice president,
clinical development. "We are pleased with the results of the study presented
this week at ASCO, and now NOVANTRONE is being tested in two larger-scale
clinical studies, that we hope will show whether it offers additional benefit
in this devastating disease."
SWOG CLINICAL STUDIES
The Southwest Oncology Group has two ongoing clinical trials with
NOVANTRONE. The first is recruiting men at high risk of failing radical
prostatectomy. The combination of six cycles of NOVANTRONE and hormone therapy
is being compared to hormone therapy alone. A second clinical trial is
evaluating Taxotere(R) plus Emcyt(R), in comparison to the standard of care,
NOVANTRONE plus prednisone, in symptomatic hormone refractory prostate cancer
patients.
HORMONE THERAPY
Hormonal therapy is the most common treatment for prostate cancer that has
recurred or spread beyond the prostate (also known as metastatic prostate
cancer). Because the spread of prostate cancer is promoted by the male hormone
testosterone, this therapy aims to curb the production of testosterone,
thereby denying the cancer cells what they need to grow. This treatment may
slow cancer growth and reduce tumor size and also may be accompanied by side
effects including hot flashes and impotence.
ABOUT NOVANTRONE
NOVANTRONE is a chemotherapy developed more than 10 years ago to treat
certain types of cancer. It is approved, in combination with corticosteroids,
to treat pain associated with advanced hormone-refractory prostate cancer, and
as a first-line therapy to treat adult acute myelogenous leukemia (AML) in
combination with other approved agents. NOVANTRONE was approved in
October 2000 by the U.S. Food and Drug Administration as the first therapy to
treat secondary progressive multiple sclerosis (MS).
In a Phase 3 clinical trial, the most common nonhematologic adverse events
in patients with hormone refractory prostate cancer treated with NOVANTRONE
were nausea (61%), fatigue (39%), alopecia (29%), anorexia (25%), constipation
(16%), and dyspnea (11%); however, most were mild to moderate.
Myelosuppression induced by NOVANTRONE may be severe and requires frequent
monitoring. Functional cardiac changes can occur with NOVANTRONE treatment
including decreases in left ventricular ejection fraction (LVEF) and
irreversible congestive heart failure (CHF). Cancer patients who received up
to a cumulative dose of 140 mg/m2 had a 2.6% probability of CHF. NOVANTRONE is
not recommended for patients with abnormal liver function tests. NOVANTRONE
should be given into a freely flowing intravenous infusion. NOVANTRONE should
not be given by subcutaneous, intramuscular, intrathecal, or intra-arterial
injection. Severe permanent injury can result from these forms of
administration. Please see full prescribing information for a more complete
listing of contraindications, warnings, precautions, and adverse reactions.
For more information about NOVANTRONE, and to obtain the full prescribing
information for NOVANTRONE, call 800-IMMUNEX (800-466-8639) or visit
http://www.novantrone.com or http://www.immunex.com.
Immunex Corporation (Nasdaq: IMNX) is a leading biotechnology company
dedicated to improving lives through immune system science innovations.
NOTE: Except for the historical information contained herein, this news
release contains forward-looking statements that involve substantial risks and
uncertainties. Among the factors that could cause actual results or timelines
to differ materially are risks associated with research and clinical
development, regulatory approvals, our supply capabilities, and reliance on
third-party manufacturers, product commercialization, competition, litigation,
and other risk factors listed from time to time in reports filed by Immunex
with the SEC, including but not limited to risks described under the caption
"Important Factors That May Affect Our Business, Our Results of Operations,
and Our Stock Price" within our most recently filed Form 10-Q. The
forward-looking statements contained in this news release represent our
judgment as of the date of this release. Immunex undertakes no obligation to
publicly update any forward-looking statements.
SOURCE Immunex Corporation
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