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www.fdanews.com/articles/67269-spectrum-completes-enrollment-in-eoquin-phase-ii-trial-for-refractory-superficial-bladder-cancer

SPECTRUM COMPLETES ENROLLMENT IN EOQUIN PHASE II TRIAL FOR REFRACTORY SUPERFICIAL BLADDER CANCER

January 7, 2005

Spectrum Pharmaceuticals has completed enrollment in the Phase II trial of EOquin as a single agent in patients with recurrent superficial bladder cancer refractory to at least one prior treatment regimen.

The primary objective of the multicenter, open-label, nonrandomized Phase II trial is to evaluate tumor response (the level of antitumor activity of EOquin), with time to recurrence and overall safety as the secondary objectives. Data previously reported from the Phase II trial confirmed antitumor activity against refractory superficial bladder cancer, as evidenced by 19 of 31 patients showing a complete response (complete disappearance of the tumor as confirmed by biopsy) after receiving six weekly treatments (via instillation into the urinary bladder) with EOquin.

Results also demonstrated that EOquin was well-tolerated, with no systemic toxicity, and local toxicity limited to chemical cystitis in one patient, dysuria and hematuria. While follow-up was short, no responding patient had relapsed, confirming the promising response duration observed in a previous Phase I trial.