Peregrine Pharmaceuticals, Inc.
) recently announced updated data on bavituximab from its
randomized, double-blind placebo-controlled phase II trial that
was conducted in patients with second-line non-small cell lung
We note that last year, the company had presented results on
bavituximab from the 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
Earlier this year, Peregrine Pharma provided an update on the
situation and gave information from an internal review of the
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.
The recently presented data from the phase II study were
updated based on the completion of the earlier review of
discrepancies in the study and the latest survival data from the
Updated results suggest a meaningful improvement in median
overall survival in the 3mg/kg bavituximab + docetaxel arm
compared to the control arm (11.7 months versus 7.3 months).
Response rates and progression free survival were also favorable
for the 3mg/kg bavituximab + docetaxel arm. Bavituximab was found
to be well-tolerated with no significant differences in adverse
events between the arms.
Peregrine Pharma intends to present these data as well as
updated subgroup analysis and safety data at an upcoming
Peregrine Pharma also intends to enter into discussions with
regulatory bodies including an end-of-phase II meeting with the
FDA by mid-2013. The company is looking to move the candidate
into a pivotal study by year-end.
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.
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
Alexion Pharmaceuticals, Inc.
). While Cytokinetics is a Zacks Rank #1 (Strong Buy)
stock, Alexion is a Zacks Rank #2 (Buy) stock. Another company
that currently looks well-positioned is
). Actelion is also a Zacks Rank #1 stock.
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