bavituximab

Now prior to clinical trials and preclinical research point to bavituximab as a monoclonal antibody with very broad potential for treating patients with cancer or viral infections.

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Although protocol amendments are costly and time-consuming to implement, these changes are having a positive impact on patient accrual and may ultimately increase the number of patients that could be prescribed our therapy if bavituximab is approved.

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Prior published data show combining the PS-targeting antibody bavituximab with gemcitabine, a chemotherapy that has been shown to increase PS exposure on tumor blood vessels, enhances anti-tumor effects and controls metastatic growth without added toxicity over gemcitabine alone in animal models of pancreatic cancer.

Peregrine Initiates Randomized Phase II Trial of Bavituximab in Pancreatic Cancer - Yahoo! Finance 2011

Approximately 70 patients with previously untreated stage IV pancreatic cancer will be randomly assigned to either gemcitabine alone or gemcitabine with bavituximab.

Peregrine Initiates Randomized Phase II Trial of Bavituximab in Pancreatic Cancer - Yahoo! Finance 2011

The open-label, multicenter trial is being conducted in the United States and will evaluate Peregrine's bavituximab, a phosphatidylserine PS-targeting monoclonal antibody with broad therapeutic potential, in combination with the chemotherapeutic agent gemcitabine versus gemcitabine monotherapy.

Peregrine Initiates Randomized Phase II Trial of Bavituximab in Pancreatic Cancer - Yahoo! Finance 2011

"With the initiation of our third randomized Phase II oncology trial for bavituximab, we are setting the stage for multiple clinical data reports over the coming year."

Peregrine Initiates Randomized Phase II Trial of Bavituximab in Pancreatic Cancer - Yahoo! Finance 2011

The primary endpoint of this trial is progression free survival PFS of patients with stage IV pancreatic cancer treated with gemcitabine alone versus gemcitabine with bavituximab.

Peregrine Initiates Randomized Phase II Trial of Bavituximab in Pancreatic Cancer - Yahoo! Finance 2011

"We were inspired to conduct this study based on the encouraging and consistent signs of bavituximab's anti-tumor activity across multiple oncology indications as well as the promising preclinical data supporting the potential of bavituximab in combination with gemcitabine in advanced pancreatic cancer models," said Steven W. King, president and chief executive officer of Peregrine.

Peregrine Initiates Randomized Phase II Trial of Bavituximab in Pancreatic Cancer - Yahoo! Finance 2011

Currently, Peregrine's bavituximab is being evaluated in combination with chemotherapy in two Phase IIb trials in non-small cell lung cancer, a Phase I/II trial in combination with sorafenib in advanced hepatocellular carcinoma (HCC), as well as a Phase Ib trial for hepatitis C virus (HCV).

Peregrine Initiates Randomized Phase II Trial of Bavituximab in Pancreatic Cancer - Yahoo! Finance 2011

The company is pursuing multiple clinical programs in cancer and hepatitis C virus infection with its lead product candidate bavituximab and novel brain cancer agent Cotara®.

Peregrine Initiates Randomized Phase II Trial of Bavituximab in Pancreatic Cancer - Yahoo! Finance 2011