Peregrine Pharmaceuticals of Tustin study progresses

Peregrine Pharmaceuticals Inc. announced Wednesday that it achieved a significant milestone in the clinical trials of its lead product candidate, bavituximab.

The drug reached primary efficacy endpoint in the first stage of its Phase II clinical trial in patients with non-small cell lung cancer (NSCLC).

The open-label, Simon two-stage study is designed to evaluate the safety and efficacy of the combination of bavituximab with the chemotherapy drugs carboplatin and paclitaxel in NSCLC patients.

Seventeen of the 21 patients enrolled in Stage A were deemed evaluable for tumor response by the end of four treatment cycles, with six patients achieving partial tumor responses and one patient achieving a complete tumor response, according to testing criteria.

These preliminary results exceed the pre-specified benchmark criteria established for enrolling an additional 28 patients in Stage B of this trial, up to a total of 49 patients.
"We are very pleased with the promising early results from this pilot Phase II lung cancer trial and will now move forward to initiate the second stage of the study," says Steven W. King, president and CEO of Peregrine. "We are encouraged by the number of tumor responses seen at this early time point of approximately 12 weeks in patients with NSCLC, a leading cause of cancer deaths that responds poorly to current treatments.

“As these patients continue on treatment, we will be assessing them for further signs of anti-tumor activity, and we look forward to sharing more data from this study as patient treatment and follow-up progress," King continues.

Lung cancer is a major cause of cancer deaths worldwide. In the U.S., lung cancer is the second most commonly diagnosed cancer in men and women and is the leading cause of cancer deaths, according to the American Cancer Society.

Estimates from the American Cancer Society show that in 2008, there were approximately 215,020 new cases of lung cancer and an estimated 161,840 lung cancer deaths in the United States alone. NSCLC is the most common type of lung cancer, accounting for approximately 85-90 percent of lung cancer cases.