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Peregrine Pharmaceuticals Updates Top-Line Data From Phase II Clinical Trial of Bavituximab in Second-Line Non-Small Cell Lung

Peregrine Pharmaceuticals Updates Top-Line Data From Phase II Clinical Trial of 
Bavituximab in Second-Line Non-Small Cell Lung
Cancer 
60% Improvement in Median Overall Survival in Patients Treated With
Bavituximab Plus Docetaxel; Data Support Advancing Bavituximab Into
Phase III Development 
TUSTIN, CA -- (Marketwire) -- 02/19/13 --  Peregrine Pharmaceuticals,
Inc. (NASDAQ: PPHM), today reported data from its randomized,
double-blind placebo-controlled Phase II trial of bavituximab in
patients with second-line non-small cell lung cancer (NSCLC). Data
from the trial has been updated based on completion of an earlier
review of discrepancies in the trial and the most current survival
data from the trial. Updated results from this Phase II trial
indicate a meaningful improvement in median overall survival of 11.7
months in the 3mg/kg bavituximab + docetaxel arm compared to 7.3
months in the control arm (HR=0.73; p value=0.217). Persistent
separation in the survival curves was observed with response rates
and progression free survival also favoring the 3mg/kg bavituximab +
docetaxel arm in this difficult to treat second-line NSCLC. The
results also demonstrated that bavituximab was well-tolerated with no
significant differences in adverse events between the trial arms.
Peregrine plans to report additional data from the trial, including
updated subgroup analysis and safety data, at an upcoming scientific
meeting.  
"These compelling results strongly support advancing the 3mg/kg
bavituximab plus docetaxel combination into Phase III development in
second-line NSCLC," said Joseph Shan, vice president of clinical and
regulatory affairs at Peregrine. "Data from this trial, along with
results from seven other ongoing bavituximab trials across many
different oncology indications, are helping guide our development
efforts for this promising drug candidate. We look forward to
reporting further data from these trials and to laying out our plans
for advancing the program into late-stage development."  
Peregrine's randomized, double-blind, placebo-controlled Phase II
trial was designed to evaluate docetaxel with bavituximab or placebo
and enrolled 121 patients with previously treated locally advanced or
metastatic NSCLC. Patients enrolled in the trial were not selected
based
 on genetic or other biomarkers. All patients had confirmed
Stage IIIb or IV non-squamous NSCLC and had progressed following one
prior chemotherapy regimen. The trial was designed to evaluate
overall response rate (ORR) measured in accordance with RECIST
criteria, progression-free survival (PFS), duration of response,
overall survival (OS), and safety.  
"From a regulatory standpoint, this trial achieved its three main
goals in preparing for a Phase III trial by identifying a dose,
augmenting the existing set of favorable bavituximab safety data, and
demonstrating good signs of survival effect in patients," said Robert
L. Garnick, Ph.D., head of regulatory affairs at Peregrine. "With
these data in hand, we are now preparing for additional discussions
with regulatory bodies including an end-of-Phase II meeting with the
FDA by mid-year with an overall goal of being in a position to
initiate a pivotal trial near year-end."  
"The conservative approach we took following our internal review of
data from this trial combines one of our bavituximab treatment arms
with the placebo group with the resulting data remaining compelling
to advance the program into Phase III development in second line
NSCLC. We remain confident that the trial has demonstrated the
potential of bavituximab in this difficult to treat disease," said
Steven W. King, president and chief executive officer of Peregrine.
"While our clinical, regulatory and manufacturing teams work together
to prepare for an end-of-Phase II meeting with the FDA, we are
continuing to update potential partners on these trial results and
our future plans for advancing the program. Partnering interest
remains high and the updates from this trial should help advance
these discussions. We would like to express our gratitude to the
patients who participated in the trial and look forward to continuing
to develop potential treatments for cancer." 
Background on Vial Coding Discrepancy 
The review was prompted by the discovery of vial coding discrepancies
while preparing for an end-of-Phase II meeting with the FDA as
announced on September 24, 2012. The internal review included a
thorough operational review of multiple third-party vendor operations
at sites worldwide, testing of investigational product used in the
trial, additional patient sample testing to determine drug levels and
a review of immunogenicity testing results from the trial. The
initial results of the extensive internal review were announced on
January 7, 2013 and indicated that discrepancies were isolated to the
placebo and 1mg/kg treatment arms of the trial and that there was no
evidence of discrepancies in the 3mg/kg treatment arm of the trial.
Based on the results of the internal review, Peregrine has taken a
conservative approach toward analyzing the results from the trial
which included combining the placebo and 1mg/kg arms into one
treatment arm (control arm), and comparing those results to the
3mg/kg arm. 
About Bavituximab 
Bavituximab is a first-in-class phosphatidylserine (PS)-targeting
monoclonal antibody that represents a new approach to treating
cancer. Bavituximab is the lead drug candidate from the company's PS
technology platform and is currently being tested in eight clinical
trials, including three randomized Phase II trials in front-line and
second-line non-small cell lung cancer and front-line pancreatic
cancer, and five investigator-sponsored trials (ISTs) in additional
oncology indications. PS is a highly immunosuppressive molecule
usually located inside the membrane of healthy cells, but "flips" and
becomes exposed on the outside of cells that line tumor blood
vessels, creating a specific target for anti-cancer treatments.
PS-targeting antibodies target and bind to PS and block this
immunosuppressive signal, thereby enabling the immune system to
recognize and fight the tumor. 
About Peregrine Pharmaceuticals, Inc. 
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a
portfolio of innovative monoclonal antibodies in clinical trials
focused on the treatment and diagnosis of cancer. The company is
pursuing multiple clinical programs in cancer with its lead product
candidate bavituximab and novel brain cancer agent Cotara(R).
Peregrine also has in-house cGMP manufacturing capabilities through
its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com),
which provides development and biomanufacturing services for both
Peregrine and outside customers. Additional information about
Peregrine can be found at www.peregrineinc.com.  
Safe Harbor Statement: Statements in this press release which are not
purely historical, including statements regarding Peregrine
Pharmaceuticals' intentions, hopes, beliefs, expectations,
representations, projections, plans or predictions of the future are
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. The forward-looking
statements involve risks and uncertainties including, but not limited
to, the risk that the major discrepancies discovered with respect to
our randomized, double-blind placebo-controlled Phase II trial of
bavituximab in patients with refractory NSCLC may cause regulatory
authorities to require further clinical trials to support a
registra
tion package, the risks that partnering discussions may not
result in a partnering transaction or that such discussions could be
hindered or delayed as a result of the potential impact on the
regulatory pathway for bavituximab caused by the major discrepancies
discovered with respect to the Phase II NSCLC trial or the existing
class action lawsuits, the risk that results from the front-line
NSCLC trail will not be consistent with results experienced in
earlier trials and may not support advancing this indication into
later stage trials. It is important to note that the Company's actual
results could differ materially from those in any such
forward-looking statements. Factors that could cause actual results
to differ materially include, but are not limited to, uncertainties
associated with completing preclinical and clinical trials for our
technologies; the early stage of product development; the significant
costs to develop our products as all of our products are currently in
development, preclinical studies or clinical trials; obtaining
additional financing to support our operations and the development of
our products; obtaining regulatory approval for our technologies;
anticipated timing of regulatory filings and the potential success in
gaining regulatory approval and complying with governmental
regulations applicable to our business. Our business could be
affected by a number of other factors, including the risk factors
listed from time to time in the our SEC reports including, but not
limited to, the annual report on Form 10-K for the fiscal year ended
April 30, 2012 and quarterly report on Form 10-Q for the quarter
ended October 31, 2012. The company cautions investors not to place
undue reliance on the forward-looking statements contained in this
press release. Peregrine Pharmaceuticals, Inc. disclaims any
obligation, and does not undertake to update or revise any
forward-looking statements in this press release.  
Contact:
Christopher Keenan or Jay Carlson
Peregrine Pharmaceuticals, Inc.
(800) 987-8256
info@peregrineinc.com 
 
 
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