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Peregrine Pharmaceuticals Provides Update on Bavituximab Clinical Program

Peregrine Pharmaceuticals Provides Update on Bavituximab Clinical Program 
Company Strengthens Cash Position as It Prepares to Initiate Phase
III Trial in Second-Line NSCLC by Year-End While Partnering
Discussions Continue; Recent Data Supporting Novel Immunotherapy
Mechanism of Action Prompts Review of Ongoing Trials Including Early
Review of Phase II Front-Line NSCLC Trial; Company Accelerating
Collection of Immune Correlative Data From Ongoing Trials While New
Immunotherapy Combination Studies Are Being Planned 
TUSTIN, CA -- (Marketwired) -- 06/27/13 --  Peregrine
Pharmaceuticals, Inc. (NASDAQ: PPHM) today provided an update on its
bavituximab oncology program including financing activities focused
on advancing its lead program into a pivotal Phase III trial and
adapting its clinical development plan in accordance with the recent
increased understanding of the immune-stimulatory properties of
bavituximab. In May, the company reached an agreement with the Food
and Drug Administration (FDA) on a Phase III trial design in
second-line non-small cell lung cancer (NSCLC) with bavituximab and
docetaxel, presented data from its trial supporting this study in
early June and is now in the process of initiating the pivotal Phase
III trial by year-end. In line with the planning for the Phase III
trial and continued development in other indications, the company
received over $24 million in net proceeds since its quarter-end
January 31, 2013 through an At Market Issuance Sales Agreement and
had over $42 million in cash as of June 24, 2013.  
Data recently presented at the annual meeting of the American
Association for Cancer Research (AACR) yielded definitive insight
into bavituximab's immunotherapy mechanism of action. These data
prompted Peregrine to undertake a review of its entire ongoing
bavituximab clinical program in order to better direct its clinical
development and further explore its therapeutic potential. Several of
the ongoing investigator-sponsored trials (IST) include immune
correlative testing which could corroborate bavituximab's
immunotherapy mechanism of action in the clinic. The company is also
actively working with its clinical collaborators on how best to
design future trials evaluating the potential of combining
bavituximab with other immunotherapy agents in addition to the
chemotherapy combinations that are currently underway.  
To further focus the strategic direction for potential upcoming
trials, Peregrine just completed an analysis of overall survival (OS)
data from its Phase II clinical trial comparing bavituximab plus
carboplatin and paclitaxel versus carboplatin and paclitaxel alone in
front-line patients with Stage IIIb and Stage IV NSCLC. This
analysis, with less than 60% of survival events, indicated that while
the bavituximab containing treatment arm currently demonstrates a
median overall survival of over 14 months, there was not a meaningful
enough difference in survival between the two arms of the trial that
would support the advancement of this combination. Full results from
the trial will be presented at a future scientific meeting or through
publication.  
"These recent data supporting an immunotherapy mechanism of action
for bavituximab opens many new development opportunities including
new combinations not previously planned and has created a lot of
excitement around the potential of bavituximab in combination with
other immunotherapeutic agents," stated Joseph Shan, vice president
of clinical and regulatory affairs at Peregrine. "While exploring
these opportunities, our primary focus remains on the initiation of
the Phase III trial in second-line NSCLC by year-end based on
promising survival data and we are on track to achieve that goal."  
The Phase III clinical trial design will be a randomized,
double-blind, placebo-controlled trial evaluating bavituximab plus
docetaxel versus docetaxel alone. The trial will enroll approximately
600 patients with metastatic, non-squamous NSCLC who have progressed
after standard front-line therapy. The primary endpoint of the trial
will be OS.  
"The recent agreement with the FDA on the Phase III trial design,
along with the successful fundraising efforts have positioned us well
for advancing the program into Phase III development, and have
strengthened our position to develop the compound including ongoing
partnering discussions," stated Steven W. King, president and chief
executive officer of Peregrine. "We expect these developments will
lead to important milestones during the second-half of the year as we
advance the bavituximab program and gain further insight into its
potential."  
In March, data from a series of preclinical studies presented at the
Annual Meeting of the American Association for Cancer Research (AACR)
demonstrated that phosphatidylserine (PS)-targeting antibodies, such
as bavituximab, mediate immuno-stimulatory changes in tumors by
acting on upstream immune checkpoints and transforming those immune
cells that are inhibiting immune recognition (MDSC's) into
tumor-fighting (M1) macrophages and activated dendritic cells that
lead to the formation of tumor fighting T-cells. Leveraging these
findings, Peregrine has initiated studies to further validate this
mechanism and evaluate how to best assess this in the four ongoing
ISTs of breast, front-line NSCLC, rectal and liver cancers.  
"By strengthening our cash position we have given ourselves the
needed flexibility to prepare for the upcoming Phase III trial,
explore the potential of bavituximab's immune mechanism and to
strengthen our position in partnering discussions," stated Paul
Lytle, chief financial officer at Peregrine. "Based on our current
financial projections, we expect our cash resources to be sufficient
to fund our operations for at the least the next twelve months as we
continue to explore all of our opportunities." 
As of June 24, 2013, the company has $42.0 million in cash and cash
equivalents compared to $26.3 million at its quarter-end January 31,
2013 and $35.2 million at its year-end April 30, 2013. Prior to the
recent front-line NSCLC data analysis, the company received $24.8
million in net proceeds since January 31, 2013 through the issuance
of equity under its At Market Issuance Sales Agreement in exchange
for 16.8 million shares of common stock sold at market prices.
Peregrine intends to use these proceeds to prepare for the initiation
of the pivotal Phase III clinical trial of bavituximab in second-line
non-small cell lung cancer and for other general corporate purposes.
Peregrine will report financial results for the fourth quarter of the
fiscal year 2013 on July 11, 2013 after market.  
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
immunotherapy 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