Peregrine Announces Completion of Patient Enrollment in Breast Cancer Clinical Trial for Bavituximab

Peregrine Announces Completion of Patient Enrollment in Breast Cancer Clinical 
Trial for Bavituximab 
Data From the Trial to Be Presented at 2013 ASCO Annual Meeting 
TUSTIN, CA -- (Marketwired) -- 04/29/13 --  Peregrine Pharmaceuticals
(NASDAQ: PPHM), a biopharmaceutical company developing first-in-class
monoclonal antibodies focused on the treatment and diagnosis of
cancer, today announced the completion of patient enrollment in an
investigator-sponsored Phase I trial evaluating bavituximab in
combination with the chemotherapeutic agent paclitaxel in patients
with metastatic HER2-negative breast cancer. Peregrine's lead
clinical candidate, bavituximab, is a phosphatidylserine
(PS)-targeting monoclonal antibody that has demonstrated promising
tumor response and survival trends in two prior Phase II advanced
breast cancer trials evaluating the compound in additional treatment
combinations. Bavituximab is currently being evaluated in several
oncology clinical trials including the lead indication of second-line
non-small cell lung cancer (NSCLC), which is anticipated to advance
into a pivotal Phase III trial later this year. 
"This represents another important milestone achieved for our
bavituximab oncology program," said Joseph S. Shan, M.P.H., vice
president of clinical and regulatory affairs of Peregrine. "Two prior
bavituximab clinical trials have demonstrated impressive tumor
response rates as well as very encouraging overall survival trends in
patients with advanced breast cancer. We look forward to data from
this investigator-sponsored trial being presented at the 2013
American Society of Clinical Oncology (ASCO) Annual Meeting." 
Interim data from the trial presented at the 2012 Annual Meeting of
the American Association for Cancer Research (AACR) showed that in
five evaluable patients with HER2-negative metastatic breast cancer,
two patients achieved a complete tumor response, one achieved a
partial response, and two had progressive disease according to
Response Evaluation Criteria In Solid Tumors (RECIST) measurement
criteria(1). 
1. Microparticle generation and activation after treatment with
paclitaxel and bavituximab combination therapy in metastatic breast
cancer.
http://www.peregrineinc.com/images/stories/pdfs/aacr_2012_mbc_ist.pdf 
About the 
Phase I Breast Cancer Trial
 In this Phase I single-arm,
open-label trial, 14 patients with HER2-negative metastatic breast
cancer were enrolled. Patients were treated with paclitaxel (80
mg/m2) weekly for three weeks out of each four-week cycle and
bavituximab (3 mg/kg) weekly. The primary endpoint is to determine
the safety, feasibility, and tolerability of combining paclitaxel
with weekly bavituximab therapy. Patients will also be assessed for
overall response rate and median progression free survival (PFS)
according to RECIST criteria. For further information about this
trial, please visit
http://www.clinicaltrials.gov/ct2/show/NCT01288261?term=bavituximab&rank=7 
About Peregrine's Investigator-Sponsored Trials (IST) Program 
Peregrine's IST program provides oncologists the opportunity to
conduct clinical trials with bavituximab and is a cost effective way
to further investigate bavituximab's therapeutic potential in
additional oncology indications and treatment combinations. To learn
more about Peregrine's IST program, please visit
http://www.peregrineinc.com/pipeline/investigator-sponsored-trials.html. 
About Breast Cancer
 The World Health Organization reports that
breast cancer is the most commonly diagnosed cancer in women and is
second only to lung cancer as a leading cause of female cancer
deaths. About 1 in 8 U.S. women will develop invasive breast cancer
over the course of her lifetime. About 39,520 women in the U.S. were
expected to die in 2011 from breast cancer. HER2-negative accounts
for approximately 75% of metastatic breast cancers. 
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-targeting technology platform and is currently being
evaluated in several solid tumor indications, including non-small
cell lung cancer, pancreatic cancer, breast cancer, liver cancer and
rectal 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,
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 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 major discrepancies discovered with respect to
our randomized, double-blind placebo-controlled Phase II trial of
bavituximab in patients with refractory NSCLC may cause regulatory
authorities to require further clinical trials to support a
registration package, the risks that partnering discussions may not
result in a partnering transaction or that such discussions could be
hindered or delayed as a result of the potential impact on the
regulatory pathway for bavituximab caused by the major discrepancies
discovered with respect to the Phase II NSCLC trial or the existing
class action lawsuits, the risk that the Company may not be able to
initiate a the pivotal Phase III trial within its anticipated
timeline, the risk that Peregrine may not have or raise adequate
financial resources to complete its other planned clinical programs
and the risk that the data from the investigator-sponsored Phase I
trial evaluating bavituximab in combination with the chemotherapeutic
agent paclitaxel in patients with metastatic HER2-negative breast
cancer may not be consistent with the promising tumor response and
survival trends in the Company's earlier two Phase II advanced breast
cancer trials evaluating the compound in additional treatment
combinations. 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, prec
linical 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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