- Five-Year Defense Threat Reduction Agency Contract Will Support
Development of Bavituximab and Fully Human Equivalent as Potential
Broad-Spectrum Anti-Viral Agents -
TUSTIN, Calif., July 1 /PRNewswire-FirstCall/ -- Peregrine
Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical
company developing monoclonal antibodies for the treatment of cancer and
hepatitis C virus (HCV) infection, today announced it has entered into a
five-year contract worth up to $44.4 million to test and develop
bavituximab and an equivalent fully human antibody as potential
broad-spectrum treatments for viral hemorrhagic fever infections. The
initial contract was awarded through the Transformational Medical
Technologies Initiative (TMTI) of the U.S. Department of Defense's Defense
Threat Reduction Agency (DTRA).
Bavituximab is Peregrine's lead anti-phosphatidylserine (anti-PS)
monoclonal antibody and is currently in clinical trials for the treatment
of HCV infections and cancer. In preclinical animal models, bavituximab has
demonstrated encouraging anti-viral activity as a potential treatment for
viral hemorrhagic fevers. Peregrine's fully human anti-PS antibody, which
will also be assessed under this contract, is currently in preclinical
development.
Under the terms of the contact, DTRA funds are available to cover
testing and development efforts totaling up to $22.3 million over a
24-month base period, with $5 million appropriated immediately for the
current federal fiscal year ending September 30, 2008. The remainder of the
$22.3 million in funding is expected to be appropriated over the remainder
of the two-year base period ending June 29, 2010. The contract can be
extended beyond the base period to cover up to $44.4 million in funding
over the five-year contract period. Work and funding under this contract
are expected to begin immediately.
"This substantial five-year contract award is especially timely in view
of recent scientific publications highlighting the broad anti-viral
potential of our anti-PS agents such as bavituximab," said Steven W. King,
president and CEO of Peregrine. "We are pleased that DTRA has recognized
bavituximab's safety profile to date and its promising anti-viral activity,
which have been demonstrated in proof of concept models of hemorrhagic
fever infection and in two successful clinical trials in patients with
chronic HCV infection."
Mr. King continued, "We welcome the opportunity to contribute to the
anti-bioterrorism mission of the Defense Threat Reduction Agency, and we
also believe that some of the work performed under this contract can be
leveraged to support common development tasks applicable to our ongoing
bavituximab clinical programs for the treatment of HCV and cancer. The
non-dilutive capital provided by this government contract will enable us to
further assess the potential of bavituximab to combat the threat of viral
hemorrhagic fevers and to help advance the overall bavituximab clinical
program."
The DTRA biodefense contract award has the potential to create
long-term value for Peregrine, including generating future potential
revenues from government stockpiling to combat bioterrorism threats. In the
near-term, funding from this initiative will also allow Peregrine to use
data and experience obtained from the development and scale-up of
bavituximab to support its ongoing clinical development programs.
"We look forward to a close partnership with the DTRA during the
performance of this program," said Ronald T. Aimes, Ph.D., associate
director of research & development at Peregrine and principal investigator
on the contract. "This is an exciting opportunity for Peregrine to
contribute to the country's defenses while also achieving important
synergies with our development programs for bavituximab and our earlier
stage anti-PS technologies."
About Bavituximab
Peregrine's monoclonal antibody bavituximab is the first in a new class
of targeted immunotherapeutics that binds to phosphatidylserine (PS), a
specific component of certain cellular membranes. PS is normally present
only on the inside of cell membranes, but becomes exposed on the external
surface of enveloped viruses and the cells they infect. Enveloped viruses
are responsible for about half of all human viral diseases, including HCV,
influenza, HIV, cytomegalovirus and hemorrhagic fevers. Scientists believe
that bavituximab helps block the ability of viruses to infect cells and
also helps stimulate the body's natural immune defenses to destroy the
virus particles and infected cells. In preclinical studies, bavituximab has
demonstrated the ability to bind to a wide range of enveloped viruses and
virally infected cells, and it has shown promising activity in animal
models of serious viral diseases. In two Phase I monotherapy trials in
patients with chronic HCV infection, bavituximab demonstrated encouraging
signs of anti-viral activity and appeared safe and well tolerated, with no
dose-limiting adverse events. A clinical trial of bavituximab for the
treatment of HCV patients co-infected with HIV is ongoing. Bavituximab is
also in multiple Phase II trials for the treatment of solid cancers.
About the Defense Threat Reduction Agency
The Defense Threat Reduction Agency (DTRA) was founded in 1998 to
integrate and focus the capabilities of the Department of Defense that
address the weapons of mass destruction (WMD) threat. The mission of the
DTRA is to safeguard America and its allies from WMD (e.g. chemical,
biological, radiological, nuclear, and high yield explosives) by providing
capabilities to reduce, eliminate, and counter the threat, and mitigate its
effects. Under DTRA, Department of Defense resources, expertise and
capabilities are combined to ensure the United States remains ready and
able to address the present and future WMD threats.
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 hepatitis C virus (HCV) infection. The company is
pursuing three separate clinical programs in cancer and HCV infection with
its lead product candidates bavituximab and Cotara(R). Peregrine also has
in-house manufacturing capabilities through its wholly owned subsidiary
Avid Bioservices, Inc. (http://www.avidbio.com), which provides development
and bio-manufacturing services for both Peregrine and outside customers.
Additional information about Peregrine can be found at
http://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 government may elect not
to extend the award beyond the two-year base period and the risk that the
award may not create long-term value for the Company. 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, 2007 and the quarterly report on Form 10-Q for the quarter ended
January 31, 2008. 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 Jennifer Anderson
(800) 987-8256 (212) 918-4642
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