Peregrine Pharmaceuticals Announces Significant Progress in

Peregrine Pharmaceuticals Announces Significant Progress in Advancing
Its Cotara Program Into a Pivotal Phase III Trial 
Agreement Reached With FDA on Pivotal Trial Design for Its Novel
Targeted Therapy Cotara for the Treatment of Recurrent Brain Cancer;
Agreement Allows for Phase III Trial Planning While Advancing
Partnering Discussions 
TUSTIN, CA -- (Marketwire) -- 12/05/12 --  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 made significant progress in
advancing its Cotara program into late-stage development through its
agreement with the U.S. Food and Drug Administration (FDA) on the
design of a single registration trial for Cotara in patients with
recurrent glioblastoma multiforme (GBM). The FDA has agreed with the
company's proposed randomized trial design comparing two dose levels
of Cotara in up to 300 patients. The trial design allows for multiple
interim data analyses with the potential to stop patient accrual
early based on predicted success or futility. Cotara has been granted
orphan drug status and Fast Track designation for the treatment of
GBM and anaplastic astrocytoma by the U.S. Food and Drug
Administration (FDA) and orphan drug designation by the European
Medicines Agency (EMA). 
"We appreciate the input that the FDA has provided to us during the
course of our discussions in order to arrive at this mutually agreed
upon design, that, if successful, should be sufficient to support a
full marketing submission," said Robert Garnick, Ph.D., Peregrine's
head of regulatory affairs. "Our next steps include the engagement of
other regulatory agencies, where we plan to run the trial as part of
a global registration study."  
Cotara is a targeted loco-regional therapy that delivers a high dose
of radiation directly into the brain tumor while sparing radiation
exposure to healthy brain tissue. Cotara is being studied as a
one-time treatment that in previous clinical trials has shown
promising overall survival in patients with recurrent GBM.  
"Our goal going into these discussions with the FDA was to agree upon
a clinical trial design that would be appropriate for this orphan
indication and one which we could enroll within a two-year
timeframe," said Joseph Shan, vice president of clinical and
regulatory affairs at Peregrine. "Having achieved this goal, we are
now beginning to plan for this global registration study while
continuing partnering discussions." 
"Having established a clear clinical path forward for this novel and
targeted delivered drug candidate, we can now escalate our business
development activities to secure a partnership, recognizing the great
interest by companies in drug candidates within the orphan and rare
disease space," said Steven W. King, president and chief executive
officer of Peregrine. "Cotara and our lead oncology therapeutic
candidate, bavituximab both represent significant opportunities. With
key data from Phase II bavituximab clinical trials in several
oncology indications set to read out in the coming months and the
opportunity to advance Cotara into a pivotal trial, we have number of
potentially significant value drivers on the horizon. We look forward
to updating you further as we continue to make progress in our late
stage clinical programs."  
About Cotara
 Based on Peregrine's Tumor Necrosis Therapy (TNT)
platform, Cotara is a novel therapy for the treatment of recurrent
GBM. Cotara links a radioactive isotope (iodine 131) to a monoclonal
antibody that targets DNA/histone H1 complex which is exposed by dead
and dying cells found at the center of solid tumors. Cotara's
targeting mechanism enables it to bind to the dying tumor cells,
delivering its radioactive payload to the adjacent living tumor cells
and essentially destroying the tumor from the inside out, with
minimal radiation exposure to healthy tissue. Cotara is delivered in
a single dose using convection-enhanced delivery (CED), an
NIH-developed method that targets the specific tumor site in the
brain. 
Data from Peregrine's prior Phase II clinical trial of a single
intratumoral infusion of Cotara in 41 patients with recurrent GBM
demonstrated promising median overall survival (OS) of 9.3 months,
with 4 patients surviving at least 3 years. 
About Brain Cancer 
 According to the Central Brain Tumor Registry of
the United States, an estimated 24,620 new cases of primary malignant
brain and CNS system tumors are expected to be diagnosed in the
United States in 2013. The most common type of brain cancer is
glioblastoma multiforme (GBM), which accounts for 60% of all
malignant brain cancers. An aggressive form of cancer, GBM is the
deadliest form of brain cancer, with a five-year survival rate of
only 3%. 
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 data from the pivotal trial may not support BLA
submission or registration, the risk that the company does not have,
or is unable to raise, sufficient capital to fund a pivotal trial and
the risk that the company is unable to find a suitable partner to
advance the Cotara 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 July 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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