Data Presented at ASCO Shows Promising 11.7 Month Median Overall Survival in Second-Line NSCLC Patients Treated With Peregrine

Data Presented at ASCO Shows Promising 11.7 Month Median Overall Survival in 
Second-Line NSCLC Patients Treated With Peregrine
Pharmaceuticals' Novel Immunotherapy Bavituximab 
Overall Survival Favors 3 mg/kg Bavituximab Plus Docetaxel Treatment
Group Over Control Arm and Across Key Subgroups Analyzed; Data
Support Global Phase III Registration Trial in Second-Line Non-Small
Cell Lung Cancer That Is Expected to Start by Year-End 
TUSTIN, CA -- (Marketwired) -- 06/03/13 --  Peregrine Pharmaceuticals
(NASDAQ: PPHM), today reported final data from its randomized,
double-blind, placebo-controlled Phase II trial of bavituximab in
patients with second-line non-small cell lung cancer (NSCLC). Final
results from the Phase II trial showed an improvement in median
overall survival (OS) of 11.7 months in the 3 mg/kg bavituximab plus
docetaxel arm compared to 7.3 months in the combined control arm,
with a persistent separation in the Kaplan Meier survival curves
(HR=0.662). In addition, subgroup analyses of overall survival by key
patient characteristics favored the bavituximab 3 mg/kg arm,
including age, gender, ECOG status, ethnicity and prior treatment.
The results also indicated that the 3 mg/kg bavituximab plus
docetaxel combination was well-tolerated with no significant
differences in adverse events between the trial arms. These results
were presented Saturday at the 2013 American Society of Clinical
Oncology (ASCO) Annual Meeting in Chicago, Illinois. 
"Immunotherapies have shown significant promise in treating solid
tumors and it is encouraging to see these latest results from
bavituximab in second-line NSCLC. Bavituximab is a unique targeted
immunotherapy with a novel mechanism of action that potentially
synergizes well with other compounds currently being developed for
oncology," said Martin J. Edelman, M.D., Professor of Medicine at the
University of Maryland Greenebaum Cancer Center. "I look forward to
being involved in the upcoming Phase III trial and to seeing the
potential of bavituximab in other indications and combinations."  
Results from the trial also showed that overall response rate (ORR)
and progression free survival (PFS) both favored the 3 mg/kg
bavituximab plus docetaxel arm. Specifically, data showed an ORR of
17.1% months in the 3 mg/kg bavituximab p
lus docetaxel arm versus
11.3% in the combined control arm and PFS of 4.2 months in the 3
mg/kg bavituximab plus docetaxel arm, versus 3.9 months in the
combined control arm.  
"These results further support our enthusiasm for advancing
bavituximab into Phase III development. With our recent agreement
with the FDA on a Phase III trial design in second-line NSCLC, we are
able to expedite our plans to advance this promising drug candidate,"
said Joseph Shan, vice president of clinical and regulatory affairs
of Peregrine. "Our goal is to initiate this Phase III trial by
year-end while we continue to gather important data from five
additional ongoing bavituximab oncology trials that will guide future
potential indications for this novel drug candidate."  
"The final data from this Phase II trial, along with the novel
mechanism of action data presented earlier this year, confirm
bavituximab is an immunotherapy that appears to have clinical
activity," said Steven King, president and chief executive officer of
Peregrine. "We look forward to advancing our ongoing partnering
discussions while continuing our plans to initiate this important
Phase III clinical trial by year-end." 
A copy of the poster can be found in the Technology section of
Peregrine's website at
http://www.peregrineinc.com/pipeline/bavituximab-oncology.html  
About the Phase II Trial  
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. Post study unblinding, vial coding
discrepancies were discovered in the placebo and 1 mg/kg vials. As a
result, data from these two arms were combined for data analysis. 
About Lung Cancer 
According to the American Cancer Society, lung cancer is the second
most commonly diagnosed cancer in the U.S., with approximately
226,160 new cases and 160,340 deaths each year, representing
approximately 28% of all cancer deaths, with a five-year survival
rate of 1%. NSCLC is the most common type of lung cancer, accounting
for approximately 85-90% of lung cancer cases. 
About Bavituximab: A Targeted Immunotherapy 
Bavituximab is a first-in-class phosphatidylserine (PS)-targeting
monoclonal antibody that represents a new approach to treating
cancer. 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, causing the
tumor to evade immune detection. Bavituximab targets PS and activates
the maturation of dendritic cells and cancer-fighting (M1)
macrophages leading to the development of cytotoxic T-cells that
fight solid tumors through blocking this immunosuppressive PS signal.
Bavituximab is the company's lead PS-targeting investigational
product and is currently being evaluated in several solid tumor
indications, including non-small cell lung cancer, breast cancer,
liver cancer and rectal cancer.  
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 third-party 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 company may not be able to initiate the Phase
III trial within its anticipated timeline, the risk that the results
from the Phase III trial may not support a future BLA submission, the
risk that the company may not have or raise adequate financial
resources to complete the Phase III trial and the risk that the
company may not find a suitable partner for the Phase III trial or
the PS program. 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 our reports filed with the Securities and
Exchange Commission including, but not limited to, our annual report
on Form 10-K for the fiscal year ended April 30, 2012 and our
quarterly report on Form 10-Q for the quarter ended January 31, 2013.
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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