Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the first patient has been dosed in Japan in a Nippon Kayaku sponsored Phase 1 study of apaziquone in bladder cancer. The Phase 1 study is required by the local regulatory authorities and is designed to enroll up to 6 patients and determine the safety and pharmacokinetics of an immediate instillation of apaziquone in the bladder following transurethral resection of bladder tumor (TURBT), followed by 6 weekly instillations of apaziquone in the bladder, starting week 4.
"We are excited that Nippon Kayaku has begun required studies of apaziquone in Japan, a major market for oncology drugs," said Rajesh C. Shrotriya, MD, Chairman of the Board of Directors, Chief Executive Officer, and President of Spectrum Pharmaceuticals.
In December 2009, Spectrum Pharmaceuticals licensed to Nippon Kayaku exclusive rights to apaziquone for the treatment of non-muscle invasive bladder cancer in Asia, including Japan and China, for an upfront licensing fee of $15 million, plus up to $136 million in milestones, and royalties. Nippon Kayaku will conduct the apaziquone clinical trials pursuant to a development plan. Nippon Kayaku will be responsible for all expenses relating to the development and commercialization of apaziquone in the Nippon Kayaku territory.
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