Peregrine Pharmaceuticals Reaches Agreement With FDA on a Phase III Trial Design for Bavituximab in Second-Line Non-Small Cell

Peregrine Pharmaceuticals Reaches Agreement With FDA on a Phase III Trial 
Design for Bavituximab in Second-Line Non-Small Cell Lung
Cancer 
Phase III Registration Trial of Investigational Immunotherapy
Expected to Start by Year-End 
TUSTIN, CA -- (Marketwired) -- 05/20/13 --  Peregrine Pharmaceuticals
(NASDAQ: PPHM), a biopharmaceutical company developing first-in-class
monoclonal antibodies focused on the treatment and diagnosis of
cancer, today announced that it has reached agreement with the U.S.
Food and Drug Administration (FDA) on a Phase III registration trial
design of the company's lead clinical immunotherapeutic candidate
bavituximab in second-line non-small cell lung cancer (NSCLC). The
trial design was supported by promising data from a Phase IIb trial
in patients treated with bavituximab plus docetaxel. Final data from
the study will be presented at the upcoming ASCO Annual Meeting on
Saturday, June 1, 2013.  
"We are very pleased with the outcome from this highly collaborative
effort with the FDA which allows us to proceed with our proposed
Phase III clinical trial," said Robert Garnick, Ph.D, head of
regulatory affairs at Peregrine. "We believe this trial, when
combined with bavituximab's supporting data to date, could be
sufficient to support a future BLA submission." 
The Phase III clinical trial will be a randomized, double-blind,
placebo-controlled trial evaluating bavituximab plus docetaxel versus
docetaxel alone enrolling approximately 600 patients at sites
worldwide. The trial will enroll Stage IIIB/IV non-squamous, NSCLC
patients who have progressed after standard front-line treatment. The
primary endpoint of the trial will be overall survival (OS).  
"The promising survival and safety data from the Phase IIb clinical
trial in second-line NSCLC combined with the safety profile from over
400 patients treated to date with bavituximab provide strong support
for this Phase III clinical trial," said Joseph Shan, vice president
of clinical and regulatory affairs of Peregrine. "We look forward to
finalizing the clinical protocol and initiating the global Phase III
trial by year-end."  
Bavituximab is a novel investigational immunotherapy that activates
the maturation of dendritic cells and cancer-fighting (M1)
macrophages leading to the development of cytotoxic T-cells that
fight solid tumors. Bavituximab has been studied in 17 clinical
trials including lung, breast, pancreatic, liver and rectal cancers.
Data from three of these clinical trials will be presented at the
ASCO Annual Meeting beginning June 1, 2013. 
"This agreement on a Phase III trial design with the FDA is a
critical milestone for the bavituximab program," said Steven King,
president and chief executive officer of Peregrine. "We will now
focus on starting the Phase III trial while continuing ongoing
partnering discussions. With immunotherapies at the forefront of new
approaches to treating cancer, we are well positioned with
bavituximab's novel immune activation mechanism to help advance this
rapidly evolving field."  
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 blocks this
immunosuppressive signal, resulting in the maturation of dendritic
cells and cancer-fighting (M1) macrophages leading to the development
of cytotoxic T-cells that fight solid tumors. Bavituximab is the lead
drug candidate from the company's PS-targeting technology platform
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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