Encouraging Results in Breast and Pancreatic Cancers for Patients Treated With Peregrine's Novel Immunotherapy Bavituximab

Encouraging Results in Breast and Pancreatic Cancers for Patients Treated With 
Peregrine's Novel Immunotherapy Bavituximab Presented at
ASCO 
Interim Data Shows 85% Overall Response Rate With 15% Complete
Response Rate in HER2-Negative MBC; Final Data From Company's Phase
II Pancreatic Cancer Trial Shows Promising Overall Survival Trends
Consistent With Immunotherapeutic Treatments 
TUSTIN, CA -- (Marketwired) -- 06/03/13 --  Peregrine
Pharmaceuticals, Inc. (NASDAQ: PPHM) reported today that data was
presented at the 2013 ASCO Annual Meeting from two clinical trials
evaluating the company's lead clinical candidate bavituximab. In the
first study presented, interim data from a Phase I trial evaluating
bavituximab plus paclitaxel therapy in patients with HER2-negative
metastatic breast cancer (MBC) showed that 85% of patients achieved
an objective tumor response, including 15% of patients achieving a
complete response (CR) measured in accordance with RECIST criteria.  
In the second study, results from a randomized Phase II trial of
bavituximab plus gemcitabine in patients with non-resectable Stage IV
pancreatic cancer demonstrated more than a doubling of the overall
response rate (ORR) and an improvement in overall survival (OS),
including a delayed separation in the Kaplan-Meier survival curve
that is commonly seen in clinical studies of promising cancer
immunotherapies. These presentations were made at the 2013 American
Society of Clinical Oncology (ASCO) Annual Meeting in Chicago,
Illinois.  
"The results of this Phase I breast cancer trial are encouraging as
there were no new safety signals and excellent clinical responses,"
said Alison Stopeck, MD, Associate Professor of Medicine and
Director, Clinical Breast Cancer Program at the University of Arizona
Cancer Center. "There were several laboratory correlative studies
associated with the trial which confirmed the safety of bavituximab
with regard to coagulation parameters." 
In this open-label trial, 14 patients with HER2-negative MBC were
treated with paclitaxel (80 mg/m2) weekly for three weeks of each
four-week cycle and bavituximab (3 mg/kg) was administered weekly
beginning on day 15 after two weekly doses of paclitaxel. Interim
results from 13 evaluable patients showed that 11 patients (85%)
achieved an objective response, including 2 patients (15%) that
achieved a complete response (CR). In addition, the combination of
bavituximab and paclitaxel was safe and well-tolerated.  
"The data from this study strongly support advancing the program into
later stage clinical studies in advanced breast cancer," said Joseph
Shan, vice president of clinical and regulatory affairs of Peregrine.
"In addition to the impressive overall response rate, we are also
seeing interesting trends in correlative lab results which we are
evaluating as potential biomarkers." 
In the pancreatic cancer study, the final results from a
company-sponsored, open-label, randomized Phase II clinical trial of
bavituximab and gemcitabine in 70 patients with previously untreated,
Stage IV pancreatic cancer continued to show encouraging activity in
this patient population with very advanced disease. Results showed
that the combination of bavituximab plus 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, 9 of 32 (28%) patients treated with a combination
of bavituximab and gemcitabine achieved an objective tumor response
as compared to 4 out of 31 (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).  
The trial included the enrollment of patients with advanced
metastatic disease, including poor performance status (ECOG 2) and
significant liver involvement associated with rapid disease
progression. Results from a subgroup analysis showed that the effect
of bavituximab plus gemcitabine was more pronounced in patients with
ECOG ≤ 1 and those without hepatic metastases.  
"We believe that these data coupled with the intriguing results from
subgroup analyses shed light on the future development potential of
bavituximab as part of the currently evolving treatment landscape of
pancreatic cancer," said Kerstin Menander, M.D., Ph.D, head of
medical oncology at Peregrine.  
A copy of the posters can be found at www.peregrineinc.com.  
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 the results of future trials of bavituximab and
paclitaxel in patients with HER2-negative metastatic breast cancer
may not be consistent with the results experienced in the Phase I
trial 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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