Poniard reports positive Phase II lung cancer drug results

The company also announced a median one-year survival rate of 17.6% in the Phase II population of mostly platinum-refractory and -resistant patients studied in this trial.

Picoplatin, the company's lead product candidate, is currently being evaluated in the pivotal Phase III SPEAR (study of picoplatin efficacy after relapse) trial in small cell lung cancer (SCLC), which is being conducted under a special protocol assessment agreement with the FDA.

The SPEAR trial is being conducted in platinum-refractory, -resistant, and -sensitive SCLC patients who have failed or relapsed from initial therapy within six months of initial treatment. It will compare picoplatin treatment with best supportive care to best supportive care alone.

The median overall survival is approximately 17 to 22 weeks for patients with recurrent SCLC who are treated with existing second-line chemotherapies, according to the 2007 national comprehensive cancer network practice guidelines.

“These updated Phase II data are consistent with earlier studies of picoplatin in this difficult-to-treat patient population and compare favorably with the median survival for the entire population of relapsed patients who receive other second-line chemotherapy,” said Jerry McMahon, chairman and CEO of Poniard.

“These results are promising because patients with platinum-resistant and -refractory small cell lung cancer have very limited treatment options. They typically experience rapid disease progression and low overall survival following treatment with existing chemotherapies, which have significant toxicities,” McMahon added.