Spectrum Announces Completion of Patient Enrollment in Ozarelix Phase II Trial in Patients with Hormone Dependent Prostate Cance
August 29 2005 - 9:01AM
PR Newswire (US)
* Complete Phase II trial enrollment ahead of projected schedule by
more than four months IRVINE, Calif., Aug. 29
/PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc.
(NASDAQ:SPPI) today announced that the Company has achieved
complete enrollment for a phase II trial of ozarelix in hormone
dependent prostate cancer ahead of schedule by more than four
months. The multicenter phase II trial is designed to evaluate the
effects of ozarelix on hormonal levels, in particular testosterone,
as well as objective anti-tumor effects. The open label trial
involving 48 patients is being conducted in Europe with the
collaboration of AEterna Zentaris (Nasdaq: AEZS; TSX: AEZ) our
licensor of ozarelix. "We are very pleased that patient enrollment
for this phase II trial of ozarelix was completed well ahead of our
planned schedule and without reports of allergic reactions so far,
a common side effect of other drugs in this class," stated Rajesh
C. Shrotriya, M.D., Chairman, Chief Executive Officer and
President. "We have been impressed with the rate of enrollment in
this trial and feel that this has been the result of the strong
collaboration between our partner, AEterna Zentaris, and Spectrum.
With enrollment now complete, we plan on reporting full results in
early 2006 and plan to submit abstracts of this data to several
significant scientific meetings in 2006." About Ozarelix Ozarelix
is a fourth generation LHRH (Luteinizing Hormone Releasing
Hormone), also known as GnRH (Gonadotropin Releasing Hormone),
antagonist. LHRH antagonists have the potential to treat
hormone-dependent cancers as well as benign proliferative disorders
such as benign prostatic hypertrophy and endometriosis. More
information on ozarelix can be found in our annual report on Form
10-K filed with the Securities and Exchange Commission. About
Spectrum Pharmaceuticals Spectrum Pharmaceuticals is a specialty
pharmaceutical company engaged in the business of acquiring,
developing and commercializing prescription drug products for the
treatment of cancer and other unmet medical needs. By leveraging
its operational flexibility and regulatory proficiency, and using
the extensive research and development capabilities of its
strategic alliance partners, Spectrum has built a diversified
portfolio of proprietary and generic drug products in various
stages of development and regulatory approval. For more
information, please visit our website at
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, the Company's operational flexibility and regulatory
proficiency, the extensive research and development capabilities of
the Company's strategic alliance partners, LHRH antagonists'
potential to treat hormone-dependent cancers as well as benign
proliferative disorders such as benign prostatic hypertrophy and
endometriosis, reporting full results in early 2006 and submitting
abstracts of this data to several significant scientific meetings
in 2006 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 past results may not be
indicative of future results including the side effects of
ozarelix, 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: Laurie Little Sr. Director, Investor
Relations (949) 743-9216 DATASOURCE: Spectrum Pharmaceuticals, Inc.
CONTACT: Laurie Little, Sr. Director, Investor Relations of
Spectrum Pharmaceuticals, Inc., +1-949-743-9216 Web site:
http://www.spectrumpharm.com/
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