Peregrine Pharmaceuticals Provides Update on Phase III SUNRISE Trial of Bavituximab
March 09 2016 - 7:46PM
Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a
biopharmaceutical company focused on developing therapeutics to
stimulate the body's immune system to fight cancer, today announced
that it is discontinuing the company’s Phase III SUNRISE trial of
bavituximab in patients with previously treated locally advanced or
metastatic non-squamous non-small cell lung cancer (NSCLC). The
decision to stop the trial was based on the recommendation of the
study's Independent Data Monitoring Committee (IDMC) following a
pre-specified interim analysis performed after 33% of targeted
overall events (patient deaths) in the study were reached. Results
of the analysis demonstrated that the bavituximab plus docetaxel
group did not show a sufficient improvement in overall survival as
compared to the docetaxel group to warrant continuation of the
study. The interim analysis showed that the bavituximab combination
group is performing as expected according to the original trial
assumptions in terms of overall survival, while the docetaxel group
is dramatically outperforming overall survival expectations based
on the original trial assumptions and as compared to recently
published studies.
"Let me start by taking this opportunity to thank all of the
patients, their families, and the physicians who participated in
the SUNRISE trial. While we are deeply disappointed by this early
outcome from the SUNRISE trial, we plan to take a deliberate and
detailed approach in reviewing and verifying all available data
from the trial in order to understand what subgroups or other
patient characteristics may have impacted the performance of the
study. While we perform this analysis, we plan to put our other
chemotherapy combination studies on hold until we have a clear
understanding of the SUNRISE study results," said Steven W. King,
president and chief executive officer of Peregrine. "While this is
an unexpected and disappointing setback for the bavituximab
chemotherapy combination clinical program, we have not seen
anything in this trial result that diminishes our enthusiasm for
advancing our immuno-oncology (I-O) combination trials. The I-O
combination studies are based on different mechanistic synergies
that are clearly separate from the chemotherapy combination being
evaluated in the SUNRISE study. In addition, it is important to
note that in no way do these results have any impact on our
contract manufacturing business conducted through our wholly owned
subsidiary, Avid Bioservices. This business has shown consistent
revenue growth and has been instrumental in maintaining a strong
cash position and our plan is to continue growing this
business."
As of February 1, 2016, Avid Bioservices had a
revenue backlog in excess of $58 million under committed contracts
from existing clients. In addition, Peregrine had $67.5 million in
cash and equivalents as of January 31, 2016.
Conference Call Today
Peregrine will host a conference call today
beginning at 4:30 PM Eastern Time (1:30 PM Pacific Time). To listen
to the conference call, please dial (877) 312-5443 or (253)
237-1126 and request the Peregrine Pharmaceuticals conference call.
To listen to the archived webcast please visit:
http://ir.peregrineinc.com/events.cfm.
About Bavituximab: A Targeted
Investigational Immunotherapy
Bavituximab is an investigational chimeric
monoclonal antibody that targets phosphatidylserine (PS). Signals
from PS inhibit the ability of immune cells to recognize and fight
tumors. Bavituximab is believed to override PS mediated
immunosuppressive signaling by blocking the engagement of PS with
its receptors as well as by sending an alternate immune activating
signal. PS targeting antibodies have been shown to shift the
functions of immune cells in tumors, resulting in multiple signs of
immune activation and robust anti-tumor immune responses.
About Peregrine Pharmaceuticals,
Inc.
Peregrine Pharmaceuticals, Inc. is a
biopharmaceutical company focused on developing therapeutics to
stimulate the body's immune system to fight cancer. Bavituximab is
the company's lead immunotherapy candidate. In addition to its drug
development programs, 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. For more information, please visit
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’s collaborator in connection with its immuno-oncology
combination trial may terminate the collaboration, the risk that
the results from the company’s immune-oncology trial may not
support further advancement of bavituximab, the risk that results
from future immune-oncology trials may not support the
submission of a Biologics License Application, the risk that the
company may not have or raise adequate financial resources from
debt and/or equity financings and/or Avid’s manufacturing
operations to fund the further development of bavituximab, the risk
that Avid's revenue growth may slow or decline, the risk that Avid
may experience technical difficulties in processing customer orders
which could delay delivery of products to customers and receipt of
payment, and the risk that one or more existing Avid customers
terminates its contract prior to completion. 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, 2015 as well as any updates to these risk factors filed from
time to time in the company's other filings with the Securities and
Exchange Commission. 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.
Contacts:
Jay Carlson
Peregrine Pharmaceuticals, Inc.
(800) 987-8256
info@peregrineinc.com
Stephanie Diaz (Investors)
Vida Strategic Partners
415-675-7401
sdiaz@vidasp.com
Tim Brons (Media)
Vida Strategic Partners
415-675-7402
tbrons@vidasp.com
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