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Data on Peregrine's Bavituximab

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Peregrine Pharmaceuticals (PPHM) recently announced phase II data on its oncology candidate, bavituximab. The open-label, randomized phase II study was conducted in patients suffering from previously untreated, advanced Stage IV pancreatic cancer.

The study compared bavituximab plus Eli Lilly’s (LLY) Gemzar (gemcitabine) to Gemzar alone. Results showed that patients in the combination arm had a 28% tumor response rate compared to 13% in the Gemzar arm. However, median overall survival, which was the primary endpoint, was modest at 5.6 months for the combination arm versus 5.2 months for the Gemzar arm.

Bavituximab in combination with Gemzar was found to be safe and well tolerated with similar adverse events occurring in both arms.

Peregrine Pharma intends to analyze the results further and present the same at a scientific meeting later this year.

Bavituximab is a key pipeline candidate at Peregrine Pharma. Bavituximab is being studied for several indications including non-small cell lung cancer in the front and second-line settings, breast, prostate, liver and rectal cancers in combination with approved chemotherapies and radiation.

We note that last year, the company had presented results on bavituximab from a phase II study for second-line non-small cell lung cancer. However, later on, Peregrine Pharma had said that the data could not be relied on due to certain discrepancies between some patient sample test results and patient treatment code assignments.

Earlier this year, Peregrine Pharma provided an update on the situation and provided information from an internal review of the discrepancies.

The company said that discrepancies were isolated to the placebo and 1 mg/kg treatment arms of the trial with no evidence of discrepancies in the 3 mg/kg treatment arm of the trial. Peregrine Pharma intends to announce detailed results from the analysis shortly.

Peregrine Pharma currently carries a Zacks Rank #3 (Hold). We expect investor focus to remain on updates on the future development path for bavituximab. Biopharma companies that currently look more attractive include Cytokinetics, Inc. (CYTK) and Targacept, Inc. (TRGT). Both are Zacks Rank #1 stocks (Strong Buy).

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