) recently received encouraging news when the company announced
that the US Food and Drug Administration (FDA) has agreed on the
design for the phase III registration trial for its oncology
Peregrine Pharma is evaluating bavituximab for the second-line
treatment of non-small cell lung cancer (NSCLC). Data from a
phase IIb trial in patients treated with bavituximab plus
) Taxotere (docetaxel) helped determine the phase III trial
The randomized, double-blind, placebo-controlled phase III
trial (n=600) will be conducted across the world among stage
IIIB/IV non-squamous NSCLC patients, whose disease progressed
after standard front-line treatment, with the primary endpoint
being overall survival. The study will compare bavituximab plus
Taxotere to Taxotere alone.
We note that bavituximab is a key pipeline candidate at
Peregrine Pharma. In addition to second-line NSCLC, bavituximab
is being studied for other indications including front-line
NSCLC, front-line pancreatic cancer, breast, liver and rectal
The agreement of a phase III trial design by the FDA is a
major relief for Peregrine Pharma considering the controversy
surrounding bavituximab's phase II results. 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.
Then, earlier this year, Peregrine Pharma provided an update
on the situation and gave information from an internal review of
the discrepancies and 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
We expect investor focus to remain on updates on the future
development path for bavituximab. The successful development and
commercialization of bavituximab would be a major positive for
Peregrine Pharma which currently has no approved drug.
Peregrine Pharma currently carries a Zacks Rank #3 (Hold).
Anika Therapeutics, Inc.
) looks attractive with a Zacks Rank #1 (Strong Buy).
) also looks well placed with a Zacks Rank #2 (Buy).
ANIKA THERAPEUT (ANIK): Free Stock Analysis
CELGENE CORP (CELG): Free Stock Analysis
PEREGRINE PHARM (PPHM): Free Stock Analysis
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