- Company on Track for Apaziquone NDA
Filing Based on Prior Phase 3 Data by Year End
- Learnings From Prior Trials and
Agreement with the FDA Through a Special Protocol Assessment (SPA)
Incorporated into Study Design
- Pivotal 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 the Company has initiated the planned Phase 3
clinical study for apaziquone, its novel, potent pro-drug, and the
first patient was dosed on Friday, October 23, 2015. Apaziquone is
an alkylating agent being investigated as intravesical treatment to
address the unmet medical need for patients with non-muscle
invasive bladder cancer (NMIBC), administered as one or two
instillations immediately following transurethral resection of
bladder tumors (TURBT).
“Apaziquone has the potential to usher in an importantly needed
paradigm shift in the treatment of NMIBC, as the first new drug in
its indication in over 40 years,” said Rajesh C. Shrotriya, MD,
Chairman and Chief Executive Officer of Spectrum Pharmaceuticals.
“This Phase 3 study has been specifically designed to address
important lessons learned from the previous apaziquone Phase 3
studies, as well as recommendations from the FDA that improve
chances of a successful study outcome. Pooled data from the
previously completed Phase 3 studies that enrolled over 1,600
patients, showed a statistically significant reduction in the
2-year Recurrence rate and strong safety data. These existing Phase
3 data form the basis of the NDA that we plan to submit to FDA
before the end of the year. Because of the high frequency of
recurrences, the overall cost for 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 are hopeful that we
can get this drug to the market as soon as possible to meet the
significant unmet medical need.”
"I am impressed with the data and the activity of apaziquone in
NMIBC that I have seen so far in clinical trials,” said
Lawrence Karsh, MD, FACS, Director of Research at The Urology
Center of Colorado. “In bladder cancer patients, there is,
unfortunately, a high rate of recurrence that necessitates frequent
surgeries. Due to the high rate of recurrence, there is significant
patient morbidity and the disease is expensive to treat. There is a
strong scientific rationale for the use of a chemotherapeutic agent
post-TURBT, and NCCN guidelines recommend the post-TURBT
instillation of a chemotherapeutic agent. However, no drug has been
specifically approved for post-TURBT instillation in the US for
this group of patients. The addition of a new effective therapy for
this recurring disease would help to address the high unmet medical
need, offer patients an important new treatment option, and
potentially reduce the healthcare costs associated with the
treatment of NMIBC.”
In accordance with the SPA agreement, this Phase 3 trial will be
a randomized, double-blind, placebo-controlled, multicenter trial
that will enroll patients with Ta, G1-G2 NMIBC. Patients will be
randomized to receive either one instillation of apaziquone, two
instillations of apaziquone, or placebo with a primary endpoint of
Time to Recurrence. Since apaziquone is known to be inactivated in
presence of blood, the new protocol requires the dosing of
apaziquone in a 30-90 minute window post-TURBT. Patients randomized
to receive two instillations of apaziquone, will receive the second
dose approximately two weeks after surgery, further minimizing the
potential for drug inactivation due to bleeding. In addition, the
protocol recommends 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, randomized
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, i.e., a reduction in the
2-Year Recurrence Rate, 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 the high recurrence rate,
intensive surveillance strategies, and expensive annual treatment
costs, bladder cancer has the highest per patient costs with an
overall cost estimated at around $3.4 billion. Non-muscle invasive
bladder cancer 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 TURBT. In the U.S., there are
approximately 300,000 TURBT procedures every year to treat bladder
cancer. Because of the high recurrence rate, both professional
urology associations and NCCN Guidelines recommend the 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 Oncology and Hematology. Spectrum
and its affiliates market five oncology drugs─ FUSILEV®
(levoleucovorin) for Injection in the U.S.; FOLOTYN® (pralatrexate
injection), also marketed in the U.S.; ZEVALIN® (ibritumomab
tiuxetan) Injection for intravenous use, for which the Company has
worldwide marketing rights; MARQIBO® (vinCRIStine sulfate LIPOSOME
injection) for intravenous infusion, for which the Company has
worldwide marketing rights,and BELEODAQ® (belinostat) for Injection
in the U.S. 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 and proven track
record 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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