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

HENDERSON, Nev.--(BUSINESS WIRE)--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”

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“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...


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