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; Toronto: 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
spectrumpharm.
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.
Spectrum Pharmaceuticals, Inc.
spectrumpharm/