Peregrine Pharma Reports Results from Phase 2 Trial of Bavituximab, Says Topline Demonstrates Signs of Anti-Tumor Activity

Peregrine Pharmaceuticals(NASDAQ: PPHM) today announced results from its 70 patientopen-label, randomized Phase II clinical trial of bavituximab used incombination with gemcitabine in patients with previously untreated,advanced Stage IV pancreatic cancer. The trial included theenrollment of patients with advanced metastatic disease includingsignificant liver involvement and poor performance status associatedwith rapid disease progression. Results showed that the combinationof bavituximab and gemcitabine resulted in more than a doubling ofoverall response rates (ORR) and an improvement in overall survival(OS) when compared with gemcitabine alone (control arm). In the trial, patients treated with a combination of bavituximab andgemcitabine had a 28% tumor response rate as compared to 13% in thecontrol arm. Median OS, the primary endpoint of the trial, was 5.6months for the bavituximab plus gemcitabine arm and 5.2 months forthe control arm (hazard ratio = 0.75). The pancreatic cancer trial is a randomized, open-label Phase IItrial evaluating bavituximab with gemcitabine versus gemcitabinealone in up to 70 patients with previously untreated stage IV pancreatic cancer. The trial allowed the enrollment of patients 18and older without any age limit, distant organ involvement and ECOGperformance status of 0-2. In this trial, bavituximab was generallysafe and well tolerated in combination with gemcitabine with similaradverse events occurring in both arms.