Spectrum Pharmaceuticals Announces Phase 2 Data for Ozarelix in Hormone-Dependent Prostate Cancer
August 02 2006 - 8:30AM
PR Newswire (US)
IRVINE, Calif., Aug. 2 /PRNewswire-FirstCall/ -- Spectrum
Pharmaceuticals, Inc. (NASDAQ:SPPI) today announced data from its
Phase 2 trial with ozarelix for patients suffering from
hormone-dependent prostate cancer. In this study, ozarelix was
administered intramuscularly in 65, 100 or 130 mg according to
different dosing schedules and repeated for 3 cycles of 28 days.
The total dose by patient during the study ranged from 230 mg to
390 mg. Patients receiving doses of 130 mg per cycle of ozarelix
have shown the greatest continuous suppression of testosterone, the
primary endpoint, where patients remained suppressed to castration
until at least day 85. In patients with continuous testosterone
suppression, tumor response as measured by PSA levels, was 97%.
Ozarelix was well tolerated at all dosages. Full detailed results
from the complete Phase 2 study will be presented at the upcoming
Societe Internationale d'Urologie (SIU) meeting to be held in Cape
Town, South Africa on November 12-16, 2006. This trial is an
open-label Phase 2 trial evaluating different intramuscular dosage
regimens of the Luteinizing Hormone Releasing Hormone (LHRH)
antagonist, ozarelix, to assess its safety and efficacy. This
study's primary endpoint is to define the most tolerable dosage
regimen of ozarelix that would ensure continuous suppression of
testosterone at castration levels (< 0.5 ng/mL) for a three
month test period. Ozarelix's effect on tumor responses are
determined by assessing serum PSA response, determined as a 50% or
greater reduction of serum PSA levels, compared to baseline. The
trial is being conducted in Europe in collaboration with Spectrum's
partner, AEterna Zentaris (NASDAQ:AEZS)(TSE:AEZ), and has enrolled
64 patients. An additional study, which will evaluate an additional
32 patients, has been initiated at other European clinical sites.
"We are encouraged by the safety and efficacy results demonstrated
in the trial thus far," stated Raj C. Shrotriya, M.D., Chairman,
President and Chief Executive Officer of Spectrum Pharmaceuticals.
"Ozarelix demonstrates the depth of our pipeline behind our other
three late-stage opportunities that include Satraplatin, LFA and
EOquin." About Ozarelix and the Development Alliance with AEterna
Zentaris Ozarelix is a fourth generation Luteinizing Hormone
Releasing Hormone LHRH antagonist administered as a depot
formulation that is being studied as a treatment for
hormone-dependent prostate cancer. In August 2004, Spectrum
received an exclusive license from AEterna Zentaris to develop and
market ozarelix for all potential indications in North America
(including Canada and Mexico) and India. In addition, Spectrum will
share with AEterna Zentaris upfront and milestone payments,
royalties or profits from sales of the product in Japan. About
Prostate Cancer Prostate cancer is the second leading cause of
cancer related deaths in men. According to the American Cancer
Society, approximately 234,460 new cases and 27,350 deaths will
occur in the U.S. during 2006. About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is opportunistically acquiring and
advancing a diversified portfolio of oncology drug candidates that
meet critical health challenges for which there are few other
treatment options. Spectrum's expertise lies in identifying
undervalued drugs with demonstrated safety and efficacy, and adding
value through further clinical development and selection of the
most viable and low-risk methods of commercialization. The
company's pipeline includes promising early and late-stage drug
candidates with unique formulations and mechanisms of action that
address the needs of seriously ill patients, such as at-home
chemotherapy and new treatment regimens for refractory disease. For
more information, please visit http://www.spectrumpharm.com/.
Forward-Looking Statements This press release may contain
forward-looking statements regarding future events and the future
performance of Spectrum Pharmaceuticals that involve risks and
uncertainties that could cause actual results to differ materially.
These statements include but are not limited to statements that
relate to our business and its future, Spectrum's ability to
identify, acquire and develop its portfolio of drug candidates, the
Company's promising pipeline, ozarelix's ability to treat
hormone-dependent prostate cancer, and any statements that relate
to the intent, belief, plans or expectations of Spectrum or its
management, or that are not a statement of historical fact. Risks
that could cause actual results to differ include the possibility
that our existing and new drug candidates may not prove safe or
effective, the possibility that our existing and new drug
candidates may not receive approval from the FDA, and other
regulatory agencies in a timely manner or at all, the possibility
that our existing and new drug candidates, if approved, may not be
more effective, safer or more cost efficient than competing drugs,
the possibility that price and other competitive pressures may make
the marketing and sale of our generic drugs not commercially
feasible, the possibility that our efforts to acquire or in-license
and develop additional drug candidates may fail, our lack of
revenues, our limited experience in establishing strategic
alliances, our limited marketing experience, our limited experience
with the generic drug industry, our dependence on third parties for
clinical trials, manufacturing, distribution and quality control
and other risks that are described in further detail in the
Company's reports filed with the Securities and Exchange
Commission. Contacts: Rajesh C. Shrotriya, M.D. Russell Skibsted
Chairman, CEO and President Sr. VP, Chief Business Officer (949)
743-9295 (949) 743-9234 DATASOURCE: Spectrum Pharmaceuticals, Inc.
CONTACT: Rajesh C. Shrotriya, M.D. Chairman, CEO and President,
+1-949-743-9295, or Russell Skibsted, Sr. VP, Chief Business
Officer, +1-949-743-9234, both of Spectrum Pharmaceuticals, Inc.
Web site: http://www.spectrumpharm.com/
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