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
a new research collaboration with the National Comprehensive Cancer
Network® (NCCN®) to expand the company’s ongoing clinical research
and development of bavituximab for the treatment of a range of
tumors. NCCN, a not-for-profit alliance of 26 of the world's
leading cancer centers devoted to patient care, research, and
education, is dedicated to improving the quality, effectiveness,
and efficiency of cancer care so that patients can live better
lives. Peregrine will fund multiple investigator-initiated
clinical and correlative studies with bavituximab in multiple
cancers at NCCN Member Institutions and their affiliate community
hospitals through a $2 million research grant to NCCN’s Oncology
Research Program (ORP). NCCN will be responsible for
oversight and monitoring of the clinical studies through the
research grant.
Bavituximab is an investigational immunotherapy
designed to assist the body's immune system by targeting and
modulating the activity of phosphatidylserine (PS), a highly
immune-suppressive signaling molecule expressed broadly on the
surface of cells in the tumor microenvironment. Peregrine’s
PS targeted inhibitor, bavituximab, is thought to reverse the
immunosuppressive environment that many tumors establish in order
to proliferate and spread, while also fighting cancer by activating
immune cells that target and fight cancer. According to
Peregrine, a broad set of preclinical and translational data has
been assembled that supports the ability of bavituximab to improve
the therapeutic activity of a range of cancer treatments, from
traditional approaches, such as chemotherapy and radiation, to
novel immuno-oncology agents such as checkpoint inhibitors.
“This collaboration with NCCN will allow us to
significantly expand our clinical evaluation of bavituximab and
augment Peregrine’s internal investigator sponsored trial (IST)
program,” said Steven W. King, president and chief executive
officer of Peregrine. “Importantly, NCCN shares our strong
research interest in evaluating unique bavituximab combination
therapies for the treatment of cancer, and the group’s oversight of
the program will allow for the conducting of many more studies than
would have been otherwise possible.”
“NCCN is very pleased to collaborate with
Peregrine Pharmaceuticals on their first-in-class novel targeted
monoclonal antibody, bavituximab,” said Robert C. Young, MD,
Interim Vice President, ORP, NCCN. “We look forward to a productive
interaction in both clinical and pre-clinical studies undertaken at
the NCCN Member Institutions.”
Peregrine expects results from this
collaboration to further support the ongoing development of
bavituximab as a key component of various combination cancer
treatments. Bavituximab is currently being evaluated in
combination with docetaxel (chemotherapy) for the treatment of
locally advanced or metastatic non-squamous non-small cell lung
cancer (NSCLC) in the ongoing Phase III SUNRISE trial. In
addition, as part of its recently formed collaboration with
AstraZeneca, Peregrine expects to initiate a global Phase II study
of bavituximab in combination with AstraZeneca’s investigational
anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), in
patients with previously treated squamous or non-squamous
NSCLC. The company will also be evaluating bavituximab with
chemotherapy combinations in HER2-negative breast cancer.
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 blocks PS, which is believed to remove this
immunosuppressive signal and send an alternate immune activating
signal. PS targeting antibodies have been shown to shift the
functions of immune cells in tumors, resulting in robust anti-tumor
immune responses.
About Peregrine Pharmaceuticals,
Inc.
Peregrine Pharmaceuticals, Inc. is a
biopharmaceutical company with a pipeline of novel drug candidates
in clinical trials focused on the treatment of cancer. The
company's lead immunotherapy candidate, bavituximab, is in Phase
III development for the treatment of previously treated non-small
cell lung cancer (the "SUNRISE trial") along with several ongoing
and planned company-sponsored trials evaluating other treatment
combinations and additional oncology indications. 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.
About the National Comprehensive Cancer
Network
The National Comprehensive Cancer Network®
(NCCN®), a not-for-profit alliance of 26 of the nation’s leading
cancer centers devoted to patient care, research, and education, is
dedicated to improving the quality, effectiveness, and efficiency
of cancer care so that patients can live better lives. Through the
leadership and expertise of clinical professionals at NCCN Member
Institutions, NCCN develops resources that present valuable
information to the numerous stakeholders in the health care
delivery system. As the arbiter of high-quality cancer care, NCCN
promotes the importance of continuous quality improvement and
recognizes the significance of creating clinical practice
guidelines appropriate for use by patients, clinicians, and other
health care decision-makers.
The NCCN Member Institutions are: Fred &
Pamela Buffett Cancer Center, Omaha, NE; Case Comprehensive Cancer
Center/University Hospitals Seidman Cancer Center and Cleveland
Clinic Taussig Cancer Institute, Cleveland, OH; City of Hope
Comprehensive Cancer Center, Los Angeles, CA; Dana-Farber/Brigham
and Women’s Cancer Center | Massachusetts General Hospital Cancer
Center, Boston, MA; Duke Cancer Institute, Durham, NC; Fox Chase
Cancer Center, Philadelphia, PA; Huntsman Cancer Institute at the
University of Utah, Salt Lake City, UT; Fred Hutchinson Cancer
Research Center/Seattle Cancer Care Alliance, Seattle, WA; The
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins,
Baltimore, MD; Robert H. Lurie Comprehensive Cancer Center of
Northwestern University, Chicago, IL; Mayo Clinic Cancer Center,
Phoenix/Scottsdale, AZ, Jacksonville, FL, and Rochester, MN;
Memorial Sloan Kettering Cancer Center, New York, NY; Moffitt
Cancer Center, Tampa, FL; The Ohio State University Comprehensive
Cancer Center - James Cancer Hospital and Solove Research
Institute, Columbus, OH; Roswell Park Cancer Institute, Buffalo,
NY; Siteman Cancer Center at Barnes-Jewish Hospital and Washington
University School of Medicine, St. Louis, MO; St. Jude Children’s
Research Hospital/The University of Tennessee Health Science
Center, Memphis, TN; Stanford Cancer Institute, Stanford, CA;
University of Alabama at Birmingham Comprehensive Cancer Center,
Birmingham, AL; UC San Diego Moores Cancer Center, La Jolla, CA;
UCSF Helen Diller Family Comprehensive Cancer Center, San
Francisco, CA; University of Colorado Cancer Center, Aurora, CO;
University of Michigan Comprehensive Cancer Center, Ann Arbor, MI;
The University of Texas MD Anderson Cancer Center, Houston, TX;
Vanderbilt-Ingram Cancer Center, Nashville, TN; and Yale Cancer
Center/Smilow Cancer Hospital, New Haven, CT.
Clinicians, visit NCCN.org. Patients and
caregivers, visit NCCN.org/patients.
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
data from one or more of the studies to be funded under this
collaboration does not further support the ongoing development of
bavituximab as a key component of certain combination cancer
treatments. 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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