- Company is on Track for Apaziquone
NDA Filing by Year End Based on Pooled Data from Two Completed
Phase 3 Studies that Showed a Statistically Significant Reduction
in 2-Year Recurrence Rates (p-value = 0.0218)
- Learnings From Earlier Phase 3
Program and FDA’s Comments Incorporated in New Phase 3 Study
Design
- New Phase 3 Study Would Satisfy
FDA’s Requirement of Initiating an Additional Phase 3 Study Before
Apaziquone NDA Submission
- NMIBC is the Fifth Most Common
Cancer in the U.S. With Highest Per Patient Cost and High Unmet
Medical Need Due to High Recurrence Rates and No FDA-approved
Agents
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology
company with fully integrated commercial and drug development
operations and a primary focus in Hematology and Oncology,
announced today that the company has reached agreement with the
U.S. Food and Drug Administration (FDA) on the Special Protocol
Assessment (SPA) of the planned Phase 3 clinical trial of its
novel, potent pro-drug, apaziquone. This trial will further
evaluate the intravesical use of apaziquone for the treatment of
patients with non-muscle invasive bladder cancer (NMIBC) as one or
two instillations, immediately following transurethral resection of
bladder tumor (TURBT).
“Spectrum’s agreement with the FDA on the SPA represents a
significant milestone for bladder cancer patients,” said Rajesh C.
Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum
Pharmaceuticals. “The learnings from previous Phase 3 studies and
comments from the FDA have been incorporated in the new protocol to
improve the chances of success. We look forward to initiating this
trial and filing the apaziquone NDA by year-end. This NDA is based
on data from the previously completed program that included two
Phase 3 studies with a total of 1,615 patients. We believe there
continues to be a significant unmet need for these patients, as no
drugs have been approved in the U.S. for more than 40 years for the
treatment of low-grade NMIBC. Due to the high rate of recurrence,
the overall cost of the treatment of bladder cancer in the U.S. is
a staggering $3.4 billion annually, most of which is related to
direct treatment of the disease. We endeavor to bring this much
needed therapy for patients and help reduce overall medical costs
at the same time."
In accordance with the SPA, the Phase 3 trial will be a
randomized, double-blind, placebo-controlled, multicenter trial
that will enroll patients with Ta G1 or G2 NMIBC. The patients will
be randomized to receive either one instillation of apaziquone, two
instillations of apaziquone, or placebo. The primary endpoint is
Time to Recurrence. Since apaziquone is known to be inactivated in
presence of blood, the new protocol includes a 30-60 minute waiting
period post-TURBT, before apaziquone instillation. Patients that
receive two instillations of apaziquone, will receive the second
dose approximately two weeks after surgery minimizing the potential
for drug inactivation due to bleeding. Further, it is recommended
that patients with significant post-operative bleeding not receive
apaziquone.
Apaziquone is an anticancer pro-drug that is activated by
bio-reductive enzymes that are over-expressed in bladder cancer
cells, rendering it into a highly cytotoxic alkylating agent.
Spectrum has conducted two multi-center, international Phase 3
trials of a single intravesical instillation of apaziquone (4 mg)
into the bladder in the immediate post-operative period after
surgical resection of low-grade NMIBC. Pooled data from the two
studies (n=1,615) showed a statistically significant treatment
effect for the primary study endpoint, 2-Year Recurrence Rates, in
favor of apaziquone (p-value = 0.0218) and in a key secondary
endpoint, Time to Recurrence (p-value = 0.0096).
About Bladder Cancer
According to the National Cancer Institute, bladder cancer is
the fifth most common malignancy in the US with 74,000 new cases of
bladder cancer expected in 2015, and currently over 500,000
patients living with the disease. Due to high recurrence rates,
intensive surveillance strategies, and expensive annual treatment
costs, bladder cancer has the highest per patient costs, and an
overall cost estimated at around $3.4 billion. Non-muscle invasive
bladder cancer (NMIBC) is a form of bladder cancer that is
localized in the surface layers of the bladder and has not invaded
or spread to the deeper muscle layer. Approximately 70% of all
patients newly diagnosed with bladder cancer have NMIBC. Urologists
treat the disease predominantly by transurethral resection of the
bladder tumor(s) (TURBT); in the U.S., there are approximately
300,000 TURBT procedures every year to treat bladder cancer.
Because of the high recurrence rates, both professional urology
associations and NCCN Guidelines recommend instillation of a
cytotoxic agent following TURBT for NMIBC, although in the U.S.,
there are no FDA-approved agents for this indication.
About Special Protocol Assessments
A Special Protocol Assessment is a written agreement between a
Sponsor and the U.S. Food and Drug Administration on the design,
execution and analysis for a clinical trial that may form the basis
of a new drug application, or NDA. Final marketing approval depends
upon the efficacy results, safety profile and an evaluation of the
risk/benefit of treatment demonstrated in the Phase 3 clinical
program.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company
focused on acquiring, developing, and commercializing drug
products, with a primary focus in Hematology and Oncology. Spectrum
markets five Hematology/Oncology drugs, and expects an FDA decision
on another hematology drug later this year. Additionally,
Spectrum's pipeline includes three drugs targeting blockbuster
markets in advanced stages of clinical development. Spectrum's
strong track record in in-licensing and acquiring differentiated
drugs, and expertise in clinical development have generated a
robust, diversified, and growing pipeline of product candidates in
advanced-stage Phase 2 and Phase 3 studies. More information on
Spectrum is available 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 and other regulatory agencies may not receive approval
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. ®, FUSILEV®, FOLOTYN®, ZEVALIN®,
MARQIBO®, and BELEODAQ® are registered trademarks of Spectrum
Pharmaceuticals, Inc and its affiliates. REDEFINING CANCER CARE™,
EVOMELA™ and the Spectrum Pharmaceuticals logos are trademarks
owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are
the property of their respective owners.
© 2015 Spectrum Pharmaceuticals, Inc. All Rights Reserved
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Spectrum Pharmaceuticals, Inc.Shiv Kapoor, 702-835-6300Vice
President, Strategic Planning & Investor
RelationsInvestorRelations@sppirx.com
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