Peregrine Pharma presents strong results from Ph II bavituximab trial

Shares of US drugmaker Peregrine Pharmaceuticals (Nasdaq: PPHM) leapt 16% to $2.45, when it announced results from its 70 patient open-label, randomized Phase II clinical trial of its lead investigation compound bavituximab used in combination with gemcitabine in patients with previously untreated, advanced Stage IV pancreatic cancer, showing a 28% tumor response rate, compared with a 13% rate in patients treated with gemcitabine alone.

The trial included the enrollment of patients with advanced metastatic disease including significant liver involvement and poor performance status associated with rapid disease progression. Results showed that the combination of bavituximab and gemcitabine resulted in more than a doubling of overall response rates (ORR) and an improvement in overall survival (OS) when compared with gemcitabine alone (control arm). Median OS, the primary endpoint of the trial, was 5.6 months for the bavituximab plus gemcitabine arm and 5.2 months for the control arm (hazard ratio = 0.75).

"We are pleased with the results seen in this very difficult to treat patient population," said Kerstin Menander, head of medical oncology at Peregrine, adding: "Although the median overall survival improvement is modest, further analysis of the data including subgroups shows some very interesting and potentially promising trends. We look forward to presenting the full data set from this trial later this year at an upcoming scientific meeting."