Spectrum Pharmaceuticals Announces Results of Apaziquone Phase 3 Clinical Trials
HENDERSON, Nev.--(BUSINESS WIRE)--
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with
fully integrated commercial and drug development operations with a
primary focus in hematology and oncology, today announced that the two
double blind, randomized, placebo controlled, Phase 3 clinical trials
for apaziquone did not meet their primary endpoint of a statistically
significant difference in the rate of tumor recurrence at 2 years
between the two arms. However, analysis of the pooled data from both
studies showed a statistically significant treatment effect in favor of
apaziquone in the primary endpoint of the rate of tumor recurrence at 2
years (p-value = 0.0174) and in a key secondary endpoint, time to
recurrence (p-value = 0.0076). The company is considering to request a
meeting with the FDA to discuss future steps.
Apaziquone is a novel anticancer drug that is activated, to become a
cytotoxic alkylating agent, by bio-reductive enzymes, such as
DT-diaphorase, that are over-expressed in bladder cancer cells. Spectrum
conducted two multi-center, Phase 3 trials of single dose intravesical
instillation of apaziquone into the bladder in the immediate
post-operative period after surgical resection of low-grade, non-muscle
invasive bladder tumors (NMIBC). Patients were randomized to apaziquone
or placebo. Under the protocol, the patients received a single 4 mg dose
of apaziquone or placebo following TURBT (Trans-Urethral Resection of
Bladder Tumor).
No drugs have been approved and marketed in the US for more than 20
years for low-grade NMIBC.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals, a biotechnology company with a primary focus
in oncology and hematology, currently markets two oncology drugs, FUSILEV®
(levoleucovorin) for Injection and ZEVALIN®(ibritumomab
tiuxetan) Injection for intravenous use. In addition, Spectrum has two
drugs, apaziquone and belinostat, in late stage development. The Company
also has a diversified pipeline of novel drug candidates. The Company's
strategy is comprised of acquiring, developing and commercializing a
broad and diverse pipeline of late-stage clinical and commercial drug
products. The Company has aggressive business development and commercial
operation teams that support a robust drug development program
encompassing clinical development, medical research, regulatory affairs,
biostatistics and data management. The Company also leverages the
expertise of its worldwide partners to assist in the execution of its
strategy. For more information, please visit the Company's website at www.sppirx.com.
Forward-looking statement — 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 are based on management's current beliefs and
expectations. These statements include but are not limited to
statements that relate to our business and its future, including certain
company milestones, Spectrum's ability to identify, acquire, develop and
commercialize a broad and diverse pipeline of late-stage clinical and
commercial products, leveraging the expertise of partners and employees,
around the world to assist us in the execution of our strategy, 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
applications to the FDA may not receive approval, 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 our
efforts to acquire or in-license and develop additional drug candidates
may fail, our lack of sustained revenue history, our limited marketing
experience, 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. We do not plan to update any such
forward-looking statements and expressly disclaim any duty to update the
information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC.®, ZEVALIN®,
and FUSILEV® are registered trademarks of
Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE™ and the
Spectrum Pharmaceutical logos are trademarks owned by Spectrum
Pharmaceuticals, Inc.
© 2012 Spectrum Pharmaceuticals, Inc. All Rights
Reserved.
Spectrum Pharmaceuticals, Inc.
Shiv Kapoor
Vice President,
Strategic Planning & Investor Relations
702-835-6300
Source: Spectrum Pharmaceuticals, Inc.
News Provided by Acquire Media
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