Poniard completes enrollment in Phase III lung cancer trial

Poniard Pharmaceuticals, a biopharmaceutical company, has reached its enrollment target of 400 patients in the Spear trial.

This global, pivotal Phase III trial is evaluating the efficacy and safety of picoplatin in patients with recurrent small cell lung cancer (SCLC) who have failed prior platinum-containing first-line chemotherapy or who have progressed within six months of first-line therapy. Patients have been enrolled at more than 100 clinical trial sites in 16 countries in Europe, South America and Asia.

The multi-center, randomized, controlled, Phase III Spear trial compares picoplatin plus best supportive care, to best supportive care alone, to evaluate the efficacy and safety of picoplatin after relapse. The primary efficacy endpoint is overall survival. Overall response rates, progression-free survival and disease control are also being evaluated.

The Spear trial is being conducted under the review of an independent Data Monitoring Committee, which assesses use of best supportive care to ensure balance in both arms of the trial, as well as the use of picoplatin and its safety in the treatment arm. The trial is also being conducted under a special protocol assessment developed with the FDA.

Jerry McMahon, chairman and CEO of Poniard, said: Completion of patient enrollment in our pivotal Phase III Spear trial represents an important milestone for Poniard. We accomplished this ahead of internal projections, which allows us to keep on schedule to complete the clinical data analysis and initiate the filing of a rolling new drug application with the FDA for picoplatin in SCLC in 2009.