Peregrine lung cancer drug extends survival
Peregrine Pharmaceuticals, Inc. has announced that interim results from a Phase 2 trial showed that, statistically, the combined use of its lung cancer drug, bavituximab, with chemotherapy drug, docetaxel, improved the overall survival rate for lung cancer patients.
Over 120 patients with refractory non-small cell lung cancer (NSCLC) took part in the Phase 2 clinical trial, which evaluated two dose levels of bavituximab given with docetaxel, versus docetaxel plus placebo. The data showed a significant improvement – patients who took bavituximab with standard chemotherapy lived a median of 12.1 months, compared with 5.6 months for those just given chemotherapy. The study was the second out of three trials needed for FDA approval.
“This study was a rigorous trial designed to minimize bias and we are encouraged that this trial yielded such positive results in the most important endpoint, overall survival. The positive overall response rates and progression free survival in both bavituximab-containing arms seen earlier in the study has now translated into a statistically significant extension in overall survival for patients, a result rarely achieved in phase II clinical trials. The quality of this data gives us a solid foundation for designing a phase III trial with an increased probability of success. We are planning for an end-of-phase II meeting with the FDA as we plan to initiate this trial by mid-2013.”
Joseph Shan, vice president of clinical and regulatory affairs at Peregrine.
Lung cancer is the second most commonly diagnosed cancer in the US, according to the American Cancer Society. There are approximately 226,160 new cases each year. NSCLC is the most common type of lung cancer, accounting for approximately 85-90% of lung cancer cases.
Shares in Peregrine rose by 47% to US $4.50 at the close in New York on 7th September 2012, following the interim results announcement.
Peregrine Study Shows Bavituximab Boosts Lung-Cancer Survival (Wall Street Journal)
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