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

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Peregrine Pharmaceuticals (NASDAQ: PPHM) today announced results from its 70 patient open-label, randomized Phase II clinical trial of bavituximab used in combination with gemcitabine in patients with previously untreated, advanced Stage IV pancreatic cancer. 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). In the trial, patients treated with a combination of bavituximab and gemcitabine had a 28% tumor response rate as compared to 13% in the 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). The pancreatic cancer trial is a randomized, open-label Phase II trial evaluating bavituximab with gemcitabine versus gemcitabine alone in up to 70 patients with previously untreated stage IV pancreatic cancer. The trial allowed the enrollment of patients 18 and older without any age limit, distant organ involvement and ECOG performance status of 0-2. In this trial, bavituximab was generally safe and well tolerated in combination with gemcitabine with similar adverse events occurring in both arms.

Posted-In: News FDA

 

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