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Peregrine Pharmaceuticals Announces Results From Phase II Clinical Trial of Bavituximab in Stage IV Pancreatic Cancer

Peregrine Pharmaceuticals Announces Results From Phase II Clinical Trial of 
Bavituximab in Stage IV Pancreatic Cancer 
Top-Line Results Demonstrate Signs of Anti-Tumor Activity in
Difficult to Treat Patient Population; Company Evaluating Next Steps
for Advancing Bavituximab Pancreatic Program 
TUSTIN, CA -- (Marketwire) -- 02/13/13 --  Peregrine Pharmaceuticals
(NASDAQ: PPHM) today announced results from its 70 patient
open-label, randomized Phase II clinical trial of bavituximab used in
combination with gemcitabine in patients with previously untreated,
advanced Stage IV pancreatic cancer. The trial included the
enrollment of patients with advanced metastatic disease including
significant liver involvement and poor performance status associated
with rapid disease progression. Results showed that the combination
of bavituximab and gemcitabine resulted in more than a doubling of
overall response rates (ORR) and an improvement in overall survival
(OS) when compared with gemcitabine alone (control arm). In the
trial, patients treated with a combination of bavituximab and
gemcitabine had a 28% tumor response rate as compared to 13% in the
control arm. Median OS, the primary endpoint of the trial, was 5.6
months for the bavituximab plus gemcitabine arm and 5.2 months for
the control
 arm (hazard ratio = 0.75).  
"We are pleased with the results seen in this very difficult to treat
patient population," said Kerstin Menander, MD, PhD, head of medical
oncology at Peregrine. "Although the median overall survival
improvement is modest, further analysis of the data including
subgroups shows some very interesting and potentially promising
trends. We look forward to presenting the full data set from this
trial later this year at an upcoming scientific meeting."  
The pancreatic cancer trial is a randomized, open-label Phase II
trial evaluating bavituximab with gemcitabine versus gemcitabine
alone in up to 70 patients with previously untreated stage IV
pancreatic cancer. The trial allowed the enrollment of patients 18
and older without any age limit, distant organ involvement and ECOG
performance status of 0-2. In this trial, bavituximab was generally
safe and well tolerated in combination with gemcitabine with similar
adverse events occurring in both arms.  
"In light of this data, as well as other recent developments in the
treatment of pancreatic cancer, we are actively evaluating the next
steps for advancing the bavituximab pancreatic program," said Joseph
Shan, vice president of clinical and regulatory affairs at Peregrine.
"Subgroup analyses from the trial are yielding additional information
that we believe will be important in guiding the anticipated future
development of bavituximab in this challenging indication. We are
considering potential development pathways that would allow us to
take advantage of bavituximab's broad potential when combined with
other cancer agents. We look forward to providing updates as these
plans come together." 
Bavituximab is being evaluated by Peregrine and individual clinical
investigators in a variety of treatment settings for patients with
non-small cell lung cancer in both the front and second-line
settings, as well as breast, prostate, liver and rectal cancers in
combination with approved chemotherapies and radiation.  
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 seven clinical
trials, including two randomized Phase II trials in front-line and
second-line non-small cell lung 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, due to the nature of this very difficult to treat
patient population and the company's continued efforts to advance
other bavituximab programs in its current pipeline, the company may
defer development in this indication pending rece
ipt of sufficient
additional financial resources or the consummation of a partnership
involving the bavituximab 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 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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