Spectrum
Pharmaceuticals, Inc. (Nasdaq: SPPI) today announced that an agreement with
the U.S. Food and Drug Administration (FDA) has been reached under the
Special Protocol Assessment (SPA) procedure for the Company's non-invasive
bladder cancer drug candidate EOquin. The SPA process allows for an
agreement between Spectrum Pharmaceuticals and the FDA on the design of a
study, including clinical drug supply, pivotal trial design, clinical
endpoints, conduct, data analysis, and other clinical trial issues, and is
intended to provide assurance that if pre-specified trial results are
achieved, they may serve as the primary basis for an efficacy claim in
support of a New Drug Application (NDA) by the Company for EOquin.
"Bladder cancer is one of the most common cancers in the U.S. and there
has not been a new treatment approved by the FDA in over 20 years. We
believe the initiation of the Phase 3 trial of EOquin is an important step
in bringing a more effective treatment for bladder cancer," stated Rajesh
Shrotriya, M.D., Chairman, President and Chief Executive Officer of
Spectrum Pharmaceuticals. "We have already selected approximately 50
investigators for the clinical trials in the U.S. and expect to conduct an
investigator's meeting on March 30-31, 2007."
The EOquin SPA calls for two double-blind, placebo-controlled,
randomized Phase 3 clinical studies, each with 562-patients with Ta G1 G2
non-invasive bladder cancer. The primary endpoint will be a statistically
significant difference (p < 0.05) in the rate of tumor recurrence between
the two treatment groups by year two. The Company currently anticipates
enrollment of the first patients in the United States trial in the second
quarter of 2007.
Bladder cancer strikes approximately 62,000 new patients in the U.S.
and approximately 180,000 patients in Europe each year. At any given time,
it is estimated that there are more than 400,000 patients in the U.S. and
more than one million patients in Europe. Bladder cancer is fifth most
expensive cancer to treat.
Additional information will be available regarding the design,
enrollment criteria, and participating centers, at spectrumpharm,
and clinicaltrials (keyword: EOquin).
About Special Protocol Assessment
The PDUFA goals for Special Protocol Assessment and agreement provide
that, upon request, FDA will evaluate within 45 days certain protocols and
issues relating to the protocols to assess whether they are adequate to
meet scientific and regulatory requirements identified by the sponsor. The
clinical protocols for Phase 3 trials can relate to efficacy claims that
will be part of an original NDA. For more information on Special Protocol
Assessment, go to fda/cber/gdlns/protocol.htm#ii.
About EOquin
EOquin (apaziquone for intravesical instillation) is a drug currently
being developed for the treatment of non-invasive bladder cancer, which is
a cancer that has invaded the inner most lining of the bladder. EOquin, an
anti-cancer agent that becomes activated by reductase enzymes found in
cancer cells, is formulated for administration directly into the urinary
bladder. In a Phase 2 pilot study for which patient accrual was completed
this year, EOquin instilled into the bladder following TUR-BT was well
tolerated and was not absorbed in any detectable amount from the bladder
wall into the bloodstream and therefore, would carry a low risk of harming
the rest of the body.
Spectrum Pharmaceuticals completed a multi-center, Phase 2 clinical
trial in Europe. The results of the trial showed that EOquin was well
tolerated and produced 67% CRs (complete responses) in patients, many of
whom had been treated multiple times. The data from this study were
presented to the FDA in early 2006.
About Bladder Cancer
The American Cancer Society estimates that there were more than 61,420
new cases of and 13,060 deaths from bladder cancer in 2006 in the United
States. The estimated patient population with bladder cancer is over
400,000 in the United States. Non-invasive bladder cancer accounts for 75%
to 80% of all cases of bladder cancer at first diagnosis. According to
Botteman et al., (PharmacoEconomics 2003), bladder cancer is the fifth most
expensive cancer to treat. The initial treatment of this cancer is surgical
removal of the tumor. Because of the high frequency of early recurrences of
the tumor, patients are usually prescribed additional therapy to prevent or
delay such recurrences. This additional therapy generally consists of
immunotherapy or chemotherapy drugs instilled directly into the bladder.
During the past 20 years or so, no new drugs have been introduced in the
market for treatment of bladder cancer.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals acquires and develops 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 our website at
spectrumpharm.
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 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,
our team's ability to identify promising drugs and opportunistically move
these drugs through development and toward commercialization, that the
initiation of the Phase 3 trial of EOquin is an important step in bringing
a more effective treatment for bladder cancer, that we will enroll the
first patients in the United States trial in the second quarter of 2007,
the safety and efficacy of EOquin 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. 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.
spectrumpharm