Spectrum Pharmaceuticals Announces Initiation of the Registrational Phase 3 Trial of Qapzola™ (apaziquone) in Patients with Non-Muscle Invasive Bladder Cancer (NMIBC)
- 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.
"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
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
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
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.
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.
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