Recent Publication Highlights Proof-of-Concept Data Supporting the Diagnostic Potential of Phosphatidylserine-Positive Exosom...
February 09 2017 - 08:05AM
Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a
biopharmaceutical company committed to improving patient lives by
manufacturing high quality products for biotechnology and
pharmaceutical companies and advancing its proprietary R&D
pipeline, today announced the publication of positive
proof-of-concept data for a novel exosome-based cancer
detection platform. Results of the study, conducted at
University of Texas (UT) Southwestern Medical Center, showed
researchers were able to distinguish between healthy subjects and
patients with ovarian tumors based on the levels of exosomes
containing phosphatidylserine (PS) found in their plasma.
Furthermore, analysis of the PS-positive exosome levels
allowed researchers to distinguish between malignant and benign
tumors. These data were recently published online by the
peer-reviewed journal, Oncotarget, in a paper titled, “Detection of
phosphatidylserine-positive exosomes as a diagnostic marker for
ovarian malignancies: a proof-of-concept study.”
Peregrine is currently advancing the proprietary
exosome-based cancer diagnostic technology, licensed from UT
Southwestern Medical Center in July 2016, with the goal of
developing an optimized test for further clinical testing. As
part of these efforts, the company is in the process of seeking a
strategic partner for collaboration on developing and
commercializing the technology. The platform is based on the
diagnostic potential of tumor exosomes, which are small vesicles
from tumor cells that are released into the blood as tumors grow.
Tumor derived exosomes have PS on their surface as a detectable
marker. It is believed that even small tumors begin to
release PS-positive exosomes and thus the ability to detect these
exosomes in the blood may be an indicator of the presence of a
tumor.
In the study published by Oncotarget, plasma
samples from 34 patients with ovarian tumors and 10 healthy
subjects were analyzed for the presence of PS-expressing exosomes
in a blinded test. Results demonstrated that those patients with
malignant ovarian cancer displayed significantly higher blood PS
exosome levels than those with benign tumors (median 0.237 vs.
-0.027, p=0.0001) and the malignant and benign groups displayed
significantly higher blood PS exosome levels than the healthy
subjects (median 0.237 vs -0.158, p<0.0001 and -0.027 vs -0.158,
p=0.0002, respectively).
“These initial proof-of-concept results are
encouraging as they appear to support the underlying concept that
the measurement of PS-positive exosome levels in blood could be a
simple way to detect and monitor cancer. While the work
is still early, we think these data serve as an important first
step in highlighting the diagnostic potential of this platform,”
said Steven W. King, president and chief executive officer of
Peregrine. “This type of diagnostic technology is
particularly important in an area such as ovarian cancer, in which
screening options are limited and the ability to detect the disease
at an early stage is inadequate. We look forward to
continuing to explore the potential of the technology platform in
ovarian as well as other types of cancer.”
“There is a significant and growing interest in
the healthcare industry around the ability to detect cancer and
monitor its progression with more readily accessible blood
tests. With this area being one of the fastest growing
segments of the oncology diagnostics market, we believe that our
exosome-based technology represents a significant product
development and licensing opportunity,” stated Stephen Worsley,
vice president of business development at Peregrine. “Based
on the fact that PS is a marker associated with a broad range of
cancer types, we believe our platform has potential applications in
several solid tumors beyond ovarian cancer. With that in
mind, we look forward to aligning with a partner to help explore
the potential of this promising technology.”
About Peregrine Pharmaceuticals,
Inc.Peregrine Pharmaceuticals, Inc. is a biopharmaceutical
company committed to improving the lives of patients by delivering
high quality pharmaceutical products through its contract
development and manufacturing organization (CDMO) services and
through advancing and licensing its investigational immunotherapy
and related products. Peregrine's in-house CDMO services,
including cGMP manufacturing and development capabilities, are
provided through its wholly-owned subsidiary Avid Bioservices, Inc.
(www.avidbio.com), which provides development and biomanufacturing
services for both Peregrine and third-party customers. The
company is also working to evaluate its lead immunotherapy
candidate, bavituximab, in combination with immune stimulating
therapies for the treatment of various cancers, and developing its
proprietary exosome technology for the detection and monitoring of
cancer. 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 may not be able to replicate the findings of this study in
larger studies, the risk that the company may not develop, or may
experience delays in developing, an optimized test that is
commercializable and/or regulatory approvable, the risk that the
company experiences difficulties in developing a test that is able
to distinguish between PS-positive exosomes from blood samples of
cancer patients and PS-positive exosomes from patients with other
diseases or illnesses that express PS-positive exosomes, the risk
that the company is unable to attract a strategic partner or
generate partnering interest in the PS-positive exosome testing
technology, and the risk that the company is unable to secure
patent protection or other intellectual property protection for the
PS-positive exosome testing technology. 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, 2016 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.
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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