Spectrum Pharmaceuticals Announces Initiation of the Registrational Phase 3 Trial of Qapzola™ (apaziquone) in Patients with...
August 14 2017 - 7:00AM
Business Wire
- Qapzola is a novel drug activated by
DT-diaphorase, an enzyme over-expressed in bladder cancer cells, to
generate cytotoxic species leading to cell death.
- NMIBC is the fifth most common
cancer in the U.S. with the highest lifetime cost per patient. It
is an unmet medical need due to high recurrence rates and no
FDA-approved drugs.
- Spectrum’s registrational Phase 3
trial, being conducted under a new Special Protocol Assessment
(SPA) agreement with the FDA, incorporates feedback from the FDA,
key opinion leaders (KOLs) and learnings from earlier
studies.
Spectrum Pharmaceuticals, Inc. (NasdaqGS:SPPI), a biotechnology
company with fully integrated commercial and drug development
operations with a primary focus in Hematology and Oncology,
announced today the Company has enrolled the first patient in a
Phase 3 trial of Qapzola, a potent tumor-activated drug being
investigated for low and intermediate risk non-muscle invasive
bladder cancer. Under the SPA, this trial will evaluate the
intravesical use of Qapzola in patients with non-muscle invasive
bladder cancer (NMIBC), as a single instillation 60 ± 30 minutes,
following transurethral resection of the bladder tumor (TURBT).
“Qapzola is being developed for low-to-intermediate risk
non-muscle invasive bladder cancer for which there are no approved
drugs in the 21st century,” said Rajesh C. Shrotriya, MD,
Chairman and Chief Executive Officer of Spectrum
Pharmaceuticals. “This is a novel drug that becomes cytotoxic only
when it encounters hypoxic tumor such as non-muscle invasive
bladder cancer. Bladder tumors are rich in DT-diaphorase, an enzyme
that converts Qapzola into an alkylating agent that leads to cell
death. One of the key challenges in the treatment of bladder cancer
is a significantly high recurrence rate which leads to exorbitant
costs and high patient morbidity. It is estimated that the cost of
treatment of this disease will surpass $5 billion by 2020. The
design of the current trial incorporates learnings from previous
studies, feedback from leading KOL’s as well as from the FDA. I
believe, Spectrum’s pipeline has never been as exciting as it is
today. In addition to aggressive development of Qapzola, we expect
to file a registration application (BLA) with the FDA for Rolontis
in 2018 and we are very excited with the early data we are seeing
with Poziotinib, our novel irreversible tyrosine kinase
inhibitor.”
In accordance with the SPA, the Phase 3 trial is a randomized,
double-blind, placebo-controlled, multi-center trial that will
enroll patients with low and intermediate risk NMIBC as per the
American Urology Association (AUA) Guidelines. The new study design
with a reduced sample size from 1557 to about 425 patients will
significantly shorten the duration of this trial. The protocol
includes a single instillation of Qapzola 60 ± 30 minute
post-TURBT, to avoid inactivation of Qapzola by blood that is
present after surgery. The patients will be randomized 2:1 to
receive either 8 mg instillation of Qapzola or placebo post-TURBT.
Following one instillation of study drug and a safety follow-up at
Day 35, subsequent follow up visits will be conducted until tumor
recurrence or end of study, whichever occurs first. The primary
endpoint for this trial is Time to Recurrence.
About Bladder Cancer
According to the National Cancer Institute, bladder cancer
is the fifth most common malignancy in the US with 79,030 new cases
of bladder cancer expected in 2017, 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 lifetime cost per patient of
all cancers, 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
currently markets six hematology/oncology drugs, and has an
advanced stage pipeline that has the potential to transform
the Company. Spectrum's strong track record for 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 Spectrum’s 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, the timing
and results of FDA decisions, 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 Spectrum’s 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 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. The Company does not plan to update any such
forward-looking statements and expressly disclaims any duty to
update the information contained in this press release except as
required by law.
SPECTRUM PHARMACEUTICALS, INC.® is a registered trademarks of
Spectrum Pharmaceuticals, Inc and its affiliate. REDEFINING CANCER
CARE™, Qapzola™ and the Spectrum Pharmaceuticals logos are
trademarks owned by Spectrum Pharmaceuticals, Inc. Any other
trademarks are the property of their respective owners.
© 2017 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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