PONIARD TO BEGIN SCLC TRIAL UNDER SPA AGREEMENT

Poniard Pharmaceuticals announced that it has reached a special protocol assessment (SPA) agreement with the FDA for its pivotal Phase III SPEAR trial of picoplatin for the treatment of small-cell lung cancer (SCLC).

Picoplatin is a new-generation platinum therapy with an improved safety profile, according to Poniard. It is designed to overcome and prevent platinum resistance associated with chemotherapy in solid tumors. Poniard received orphan drug designation in November 2005 for picoplatin for the treatment of SCLC.

Based on the positive interim median overall survival data from Poniard's ongoing Phase II clinical trial of picoplatin in patients with SCLC announced last month, the company plans to initiate the SPEAR trial in the first half of 2007. The primary endpoint of the Phase III international, multicenter, randomized trial will be overall survival. Overall response rates, progression-free survival and disease control also will be evaluated.

The company expects to enroll approximately 400 patients in the trial, which is expected to take about 20 months to complete enrollment and follow up. The trial will have a 2-1 randomization comparing picoplatin plus best supportive care to best supportive care alone, and will include patients who are refractory to, or who have progressed within six months of completing, treatment with first-line platinum chemotherapy (cisplatin or carboplatin). The company expects to file a new drug application for the SCLC indication in 2009.