Peregrine Pharmaceuticals Presents Promising Antiviral Data at 2009 Chemical and Biological Defense Science & Technology Conference
- In Preclinical Studies, Peregrine's PS-Targeting Antibodies Including Bavituximab Demonstrated Broad Spectrum Binding to Viruses and Virally Infected Cells Representing Three Viral Hemorrhagic Fever (VHF) Families - - Preclinical Efficacy Studies Showed that a Single Dose of PS-Targeting Antibodies Increased the Survival of Hamsters Lethally Infected with VHF Viruses - - Bavituximab is Also Currently Being Evaluated in a Phase I Clinical Trial in Patients Co-infected with HCV and HIV -
TUSTIN, Calif., Nov. 18 /PRNewswire-FirstCall/ -- Peregrine
Pharmaceuticals, Inc. (NASDAQ:PPHM) today announced that researchers
presented positive data on progress in its federally funded
preclinical viral hemorrhagic fever (VHF) program, confirming that
its phosphatidylserine (PS)-targeting antibodies bind to VHF
viruses and virally infected cells and increase survival in a model
of lethal VHF infection. The data were presented at the 2009
Chemical and Biological Defense Science and Technology (CBD
S&T) Conference in Dallas, Texas.
Researchers presented interim data from Peregrine's multi-year
program to assess the company's PS-targeting antibodies as
broad-spectrum agents for the treatment of viral hemorrhagic
fevers, a potential biodefense threat. The studies evaluated the
activity of Peregrine's PS-targeting antibodies against
representatives of major VHF virus families. In these studies,
researchers confirmed broad spectrum PS-targeting antibody binding
to VHF viral particles and also demonstrated that Peregrine's
PS-targeting antibodies bind to mammalian cells infected with
hemorrhagic fever viruses. Initial pharmacokinetic and dosing
studies also showed that the PS-targeting antibodies are
sustainable in the blood at therapeutically relevant
concentrations.
Importantly, initial antiviral efficacy studies reported at the
conference were encouraging, showing that a single dose of a
PS-targeting antibody increased the survival of hamsters infected
with lethal doses of viruses from two different VHF virus families.
Based on these positive findings, additional efficacy studies,
including repeat dose and combination therapy studies, are now
underway.
Dr. Amy Brideau-Andersen, head of Peregrine's preclinical
antiviral program and lead author of the studies presented at the
CBD S&T Conference, noted, "The early data from our antiviral
program designed to test the potential of our PS-targeting
antibodies to prevent and treat viral hemorrhagic fevers is very
encouraging, and we are pleased to have the opportunity to present
our findings at this major meeting of our biodefense peers. Results
to date are confirming that our PS-targeting antibodies may have
broad spectrum potential against multiple viruses, which could make
them valuable against both hemorrhagic fever viruses and other
biodefense threats. Further efficacy studies are already underway
and we look forward to reporting on our progress as we continue to
advance this important program."
Researchers also reported that studies are in progress to
determine the pharmacokinetics and efficacy of PS-targeting
antibodies in additional VHF infection models, as well as to
develop lyophilized formulations suitable for an extended shelf
life under a variety of storage and shipping conditions. In
addition, Peregrine is developing a second-generation, fully human
PS-targeting antibody as part of its federally funded antiviral
program efforts.
"These positive initial efficacy data after administration of
only a single dose is an early confirmation of the potential of our
anti-PS antibodies as broad-spectrum therapeutics for VHF," said
Steven W. King, president and CEO of Peregrine. "They also reflect
the excellent progress being achieved by our multi-institutional
project team. This first public presentation of data from our
ongoing federally funded program is also consistent with our
extensive preclinical and clinical experience showing the
broad-spectrum antiviral potential of our PS-targeting technology
platform and we look forward to sharing more results from the
studies as further progress is made."
Under a major biodefense initiative, bavituximab and a fully
human equivalent antibody are in preclinical development for the
treatment of viral hemorrhagic fevers under a federal contract
worth up to $44.4 million. This contract, which is funding work at
Peregrine and at several collaborating institutions, was awarded
based on positive data from earlier studies in animals infected
with VHF that was funded by a previous grant from NIAID.
Bavituximab, which is Peregrine's most advanced PS-targeting
antibody, is currently being studied in a clinical trial for the
treatment of patients co-infected with HCV and HIV. Phase I studies
in HCV patients showed that bavituximab was well tolerated and it
exhibited encouraging signs of anti-viral activity. Bavituximab is
also being tested in Phase II clinical trials for the treatment of
advanced breast cancer and non-small cell lung cancer.
Peregrine's collaborators at UT Southwestern Medical Center, the
University of Utah at Logan and the University of Texas Medical
Branch at Galveston also contributed to this research. The poster,
"Phosphatidylserine-Targeting Antibodies as Therapeutic Agents for
Viral Hemorrhagic Fever Infections," A. Brideau-Andersen, M.
Soares, P. Thorpe, B. Gowen, J. Julander, A. Grant, C.J. Peters, W.
Chu, S. Hirst, M. Wakabayashi, K. Schlunegger, B. Freimark, was
presented on November 17, 2009 at the 2009 Chemical and Biological
Defense Science and Technology Conference.
About Phosphatidylserine (PS)-Targeting Antiviral Agents
PS, a lipid molecule normally found only on the inside of cell
membranes, becomes exposed on the outside of the membranes of
viruses and virally infected cells. A rapidly growing body of
published scientific research confirms that exposed PS is directly
involved in the pathogenesis of many serious infectious diseases.
Exposed PS enables viruses to evade immune recognition and dampens
the body's normal responses to infection. By masking the exposed
PS, PS-targeting antibodies are believed to block these effects,
allowing the body to develop a robust immune response to the
pathogen. Peregrine's PS-targeting antibodies have been shown to
help clear infectious virus from the bloodstream and to induce
antibody-dependent cellular cytotoxicity. PS is exposed on the
outer membrane of cells infected with a wide range of viruses,
including HIV, influenza, herpes simplex viruses, hemorrhagic fever
viruses, cytomegalovirus (CMV), measles and members of the smallpox
and rabies virus families, suggesting that PS-targeting agents may
provide a broad platform for treating viral infections. Because the
PS target is host-derived rather than pathogen-derived,
PS-targeting antibodies are also expected to be much less
susceptible to the viral genomic mutations that lead to antiviral
drug resistance.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company
with a portfolio of innovative product candidates in clinical
trials for the treatment of cancer and serious virus infections.
The company is pursuing three separate clinical programs in cancer
and HCV infection with its lead product candidates bavituximab and
Cotara®. Peregrine also has in-house manufacturing capabilities
through its wholly owned subsidiary Avid Bioservices, Inc.
(www.avidbio.com), which provides development and bio-manufacturing
services for both Peregrine and outside 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 will not receive the full
$44.4 million awarded under the federally funded program, the risk
that bavituximab will not achieve broad-spectrum anti-viral
effects, the risk that PS-targeting antibodies will not be less
susceptible to viral mutations and the risk that the results of
clinical trials will not correlate to the preclinical study
results. 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 the company's SEC
reports including, but not limited to, the annual report on Form
10-K for the year ended April 30, 2009 and the quarterly report on
Form 10-Q for the quarter ended July 31, 2009. 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: GendeLLindheim BioCom Partners Investors Media info@peregrineinc.com Barbara Lindheim (800) 987-8256 (212) 918-4650
Source: Peregrine Pharmaceuticals, Inc.
CONTACT: Investors, 1-800-987-8256, info@peregrineinc.com, or
Media,
Barbara Lindheim of GendeLLindheim BioCom Partners,
+1-212-918-4650, for
Peregrine Pharmaceuticals, Inc.
Web Site: http://www.peregrineinc.com/
Posted: November 2009
