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Peregrine Pharmaceuticals (PPHM) Announces Preliminary Results for Phase II Hepatitis Study

Peregrine Pharmaceuticals Inc., a biopharmaceutical company focused on developing first-in-class monoclonal antibodies for the treatment of cancer and viral infections, today issued an update on its randomized phase II bavituximab study in patients infected with genotype-1 chronic hepatitis C virus (HCV).

The goals of the study were to compare the safety profile of bavituximab plus ribavirin with a interferon and ribavirin combination.

Preliminary data indicates that the combination of bavituximab and ribavirin appeared safe and well-tolerated in patients who reported fewer side effects than in the interferon-containing arm. The study also indicated that both dose levels of bavituximab with ribavirin demonstrated antiviral activity, however the antiviral effects in patients receiving the 0.3 mg/kg dosing level were more pronounced.

“We are pleased with the initial results we have seen from this clinical study evaluating the combination of bavituximab with an established antiviral drug in HCV patients. We see good evidence that the combination of bavituximab with ribavirin has a better safety profile than an interferon containing regimen which was one of the primary objectives of the study,” Joseph S. Shan, vice president of clinical and regulatory affairs at Peregrine stated in the press release.

Shan also noted that while both dose levels of bavituximab were active, the lower dose level appears more active in HCV patients than the high dose level, and that these preliminary results are important in validating that the combination of bavituximab with its immunological mechanism of action with an active antiviral agent that has a good safety profile and promising antiviral activity.

“These results suggest that future studies evaluating longer bavituximab treatment durations at or around the lower dose level in combination with ribavirin and potentially direct acting antivirals in certain patient populations may hold promise as interferon-free HCV therapeutic regimens,” Shan stated.

“The early data from this trial are promising and suggest that continued development of bavituximab in HCV patients is warranted to explore the full immune-modulating potential of the compound in combination with antiviral agents,” added Shan.

Steven W. King, president and CEO of Peregrine, said the company will use the data to seek development partners interested in advancing the PS-targeting antiviral program. Peregrine will continue to focus its resources on its bavituximab oncology clinical program.

The company said it plans to present full results from the study at a medical conference in 2012.

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