12 January 2010 - US Spectrum Pharmaceuticals (NASDAQ: SPPI) said today it has completed the enrollment of patients in the second of two Phase III pivotal clinical trials of apaziquone in non-muscle invasive bladder cancer.

The completion of the enrollment triggered USD1.5m (EUR1m) milestone payment to Spectrum under its collaboration agreement with US peer Allergan (NYSE:AGN).

The apaziquone registration plan, which the US Food and Drug Administration (FDA) concurred with under a Special Protocol Assessment, calls for two double blind, placebo-controlled, randomised Phase III clinical studies, each with 562 evaluable patients with Ta G1 or G2 low risk non-invasive bladder cancer. Patients are randomised in a one-to-one ratio to apaziquone or placebo.

Under the protocol, the patients are given a single 4 mg dose following surgical removal of the tumors. The primary endpoint is the rate of tumor recurrence between the two treatment groups at year two. Spectrum also received scientific advice from the European Medicines Agency (EMEA), whereby the EMEA agreed that the two Phase III studies as designed should be sufficient for a regulatory decision regarding European registration.

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