Lung cancer patients who took Peregrine’s bavituximab with standard chemotherapy lived a median of 12.1 months, compared with 5.6 months for those given just chemotherapy, according to interim results of the trial presented at a medical meeting in Chicago. The study was from second of three phases of testing needed for U.S. Food and Drug Administration.
The results are promising and bolster Peregrine’s plans to continue developing the drug, which works by stimulating the immune system, said Charles Duncan, an analyst at JMP Securities in New York. The company is “in discussions” with potential partners to help with final clinical trials, said Chief Executive Officer Steven W. King.
“The quality of this data gives us a solid foundation for designing a Phase III trial with an increased probability of success,” Joseph Shan, vice president of clinical and regulatory affairs at Peregrine, said in a statement. “We are planning for an end-of-phase II meeting with the FDA as we plan to initiate this trial by mid-2013.”
Lung cancer causes 160,340 deaths each year in the U.S., exceeding any tumor type, according to the American Cancer Society. More than 225,000 people will be diagnosed with it in 2012, the most after breast cancer in women and prostate cancer in men. Non-small-cell lung cancer is the most common form of the disease, accounting for as many as 90 percent of cases. Few patients are alive five years after diagnosis.
The study included patients who failed to respond to previous treatment; 79 were given bavituximab and 38 a placebo. While patients receiving the drug had longer overall survival, the treatment didn’t slow the tumors’ progress.
That might be because bavituximab works by disrupting the vascular support for the tumors and stimulating the immune system, which means the potency may increase with time, Duncan said in a telephone interview. Strengthening the immune system can take a while to work, giving a greater long-term response to treatment, he said.
“This drug doesn’t necessarily have any inherent killing properties, but it does bolster the immune system,” he said. “Hopefully, over time, the immune system wins.”
Peregrine is studying the drug in non-small-cell lung cancer, pancreatic cancer and other tumor types, as well as other conditions including hepatitis C and viral infections.
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