Spectrum Pharmaceuticals achieves its enrollment target in second of two apaziquone Phase 3 trials

Jan 13 2010

Spectrum Pharmaceuticals (NasdaqGM: SPPI) today announced that the second of two Phase 3 pivotal clinical trials of apaziquone has achieved its enrollment target. The two trials enrolled more than 1600 patients with non-muscle invasive bladder cancer. As per the collaboration agreement with Allergan, a $1.5 million milestone payment will be paid to Spectrum Pharmaceuticals.

“Enrolling more than 1,600 bladder cancer patients in 30 months is a clear demonstration of our clinical capabilities with respect to managing global trials and represents a remarkable achievement for our clinical team”

“We are delighted to have achieved our enrollment objectives in both clinical trials on target,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals, Inc. “Currently, there are no FDA approved drugs for immediate instillation following trans-urethral resection of bladder tumor (TUR-BT). If apaziquone meets its primary endpoint and is ultimately approved by the FDA, apaziquone would be the first FDA approved drug for immediate installation following TUR-BT. In due course, we look forward to evaluating the safety and efficacy of apaziquone in bladder cancer, and the ‘fast-track’ designation should help expedite the drug’s review process with the FDA.”

“Enrolling more than 1,600 bladder cancer patients in 30 months is a clear demonstration of our clinical capabilities with respect to managing global trials and represents a remarkable achievement for our clinical team,” added Andrew Sandler, MD, Chief Medical Officer of Spectrum Pharmaceuticals, Inc.

The apaziquone registration plan, which the U.S. Food and Drug Administration (FDA) concurred with under a Special Protocol Assessment, calls for two double blind, placebo-controlled, randomized Phase 3 clinical studies, each with 562 evaluable patients with Ta G1 or G2 low risk non-invasive bladder cancer. Patients are randomized 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 3 studies as designed should be sufficient for a regulatory decision regarding European registration.