Peregrine
Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical
company developing targeted antibodies for the treatment of cancer and
hepatitis C virus (HCV) infection, today announced it has filed a new
clinical trial protocol with the FDA to study bavituximab in patients
co-infected with HCV and the human immunodeficiency virus (HIV). The
multi-center trial will initially be conducted at Saint Michael's Medical
Center in Newark, NJ under the direction of Dr. Stephen Smith, director of
the Peter Ho Memorial Clinic, the largest HIV/AIDS treatment facility in
the state.
"Chronic co-infection with the hepatitis C virus affects a significant
proportion of our HIV patients, yet current HCV therapies are often
ineffective or poorly tolerated," said Dr. Smith. "These patients are
particularly vulnerable since co-infection is associated with more
aggressive progression of HCV-associated liver disease. We look forward to
the opportunity to study bavituximab in co-infected patients so we can
begin to assess whether its distinctive immunotherapeutic mechanism might
be of value in treating this underserved population."
The new study is an open-label, dose escalation study designed to
assess the safety and pharmacokinetics of bavituximab in approximately 24
patients chronically infected with HCV and HIV. Patient cohorts will
receive ascending dose levels of bavituximab weekly for up to 8 weeks. HCV
and HIV viral titers and other biomarkers will be tracked, although they
are not formal study endpoints.
"We believe that bavituximab's unique targeting mechanism has the
potential to act on both HCV and HIV virus infections," said Steven W.
King, president and CEO of Peregrine. "Greater understanding of
bavituximab's activity in the HCV/HIV co-infection setting should help
guide our future development efforts, potentially allowing us to treat an
HCV patient population typically excluded from clinical studies. We are
especially pleased to be pursuing this clinical trial in collaboration with
Dr. Smith, a leader in researching infectious diseases and in providing
high quality care to people with HIV."
In the United States alone, an estimated 300,000 individuals are
co-infected with HIV and HCV, representing up to 30% of all HIV-infected
patients. Co-infected patients have been shown to have a lower response to
interferon/ribavirin HCV regimens and the adverse effects of these regimens
can be especially problematic for some HIV patients.
Bavituximab is a monoclonal antibody in a new class of anti-
phosphotidylserine (PS) immunotherapeutics that targets and binds to
cellular components that are normally not present on the outside of cells,
but which become exposed on certain virally infected cells and on the
surface of enveloped viruses, including both HCV and HIV. Bavituximab helps
stimulate the body's immune defenses to destroy both the virus particles
and the infected cells. Since bavituximab's PS target comes from the host
and not the virus, bavituximab is expected to be less susceptible to the
development of anti-viral resistance than many other therapies. Bavituximab
has successfully completed Phase la and lb clinical trials as monotherapy
in patients with chronic HCV infection, which showed that the drug is well
tolerated and demonstrated encouraging signs of anti-viral activity.
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 in
the U.S. and India with its lead product candidates bavituximab and
Cotara(R). Peregrine also has in-house manufacturing capabilities through
its wholly owned subsidiary Avid Bioservices, Inc. (avidbio), which
provides development and bio-manufacturing services for both Peregrine and
outside customers. Additional information about Peregrine can be found at
peregrineinc.
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 results from the
co-infected HCV/HIV clinical trial will not be consistent with the results
from the Company's prior HCV clinical trials and the risk that bavituximab
will not be as effective as the current standard of care for co-infected
patients. 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, 2006 and the quarterly
report on Form 10-Q for the quarter ended January 31, 2007. 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.
Peregrine Pharmaceuticals, Inc.
peregrineinc