Reuters: Regulatory News: Peregrine Pharma agrees with FDA on lung cancer trial design

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Peregrine Pharma agrees with FDA on lung cancer trial design May 20th 2013, 13:36 Mon May 20, 2013 9:36am EDT May 20 (Reuters) - Peregrine Pharmaceuticals said it reached an agreement with the U.S. Food and Drug Administration on the design of a late-stage trial for its experimental lung cancer drug. The late-stage trial will compare a combination of chemotherapy and the drug, bavituximab, with chemotherapy alone. The main goal of the trial would be to show an improvement in overall survival of patients. Peregrine shares were up 19 percent at $1.83 in early trade on Monday on the Nasdaq. Bavituximab is being developed to treat second-line non-small-cell lung cancer and multiple other cancers. "We look forward to finalizing the clinical protocol and initiating the global Phase III trial by year-end," Joseph Shan, vice president of clinical and regulatory affairs, said in a statement. Peregrine went through tough times last year after it found discrepancies in the results of a mid-stage trial testing bavituximab in non-small-cell lung cancer. Following the discovery of errors in clinical data, the company was forced to pay off a loan, leaving the company with enough capital to fund operations only till April. The company, however, managed to raise capital in October to fund clinical and development goals for the next 12 months. It also reported revised data from the lung cancer trial in February.

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