Peregrine
Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical
company developing targeted monoclonal antibodies for the treatment of
cancer and hepatitis C virus infection, today announced that the first
patient has been administered Cotara(R) in a new clinical trial designed to
evaluate the safety and efficacy of this novel tumor necrosis therapy being
developed for the treatment of glioblastoma multiforme (GBM), a deadly form
of brain cancer.
"We are delighted that patient treatment has begun in this important
Phase II clinical trial that was designed to further confirm the
encouraging signs of anti-tumor activity seen in earlier Cotara brain
cancer studies," said Steven W. King, president and CEO of Peregrine.
"Given the high level of interest at participating clinical sites, we are
optimistic that patient enrollment and dosing will proceed at a brisk
pace."
This multi-center open label Phase ll safety and efficacy study is
designed to enroll up to 40 glioblastoma patients who have experienced a
first relapse. The study's primary objective is to confirm the maximum
tolerated dose of Cotara in these GBM patients. Secondary objectives
include estimates of overall patient survival, progression free survival
and the proportion of patients alive at six months. Patients in the trial
are receiving a single infusion of Cotara by convection-enhanced delivery
(CED), an NIH-developed technique that delivers the agent to the tumor with
great precision, achieving up to a 10,000-fold greater concentration in
local therapy exposure than conventional intravenous drug administration,
while minimizing unwanted exposure to healthy tissue. This delivery method
is expected to further enhance the tumor-killing potential of Cotara.
The new Cotara study is being conducted according to internationally
accepted ICH GCP guidelines.
About Cotara(R)
Cotara is an experimental new treatment for brain cancer that links a
radioactive substance designed for medical uses--a radioactive isotope--to
a targeted monoclonal antibody. This monoclonal antibody is designed to
bind to a type of DNA that is exposed only on dead and dying cells. Solid
tumors, including brain tumors, have a significant number of dead and dying
cells at their center and Cotara's targeting mechanism enables it to home
in on these dying tumor cells, delivering its radioactive "payload"
directly to the center of the tumor mass. Cotara thus destroys the tumor
"from the inside out," with minimal radiation exposure to healthy tissue.
Cotara is delivered through a special method called convection-enhanced
delivery (CED), which directs Cotara to the tumor by using a catheter to
bypass the blood brain barrier and target the specific tumor site in the
brain.
In a previous study, a subset of patients with recurrent glioblastoma
treated with Cotara achieved a median survival of 38 weeks, a 58% increase
over the median survival time of 24 weeks for patients treated with
standard of care therapy. In this study, 25% of 28 recurrent patients
survived for more than a year post-treatment and 10% of patients survived
for more than three years. These data are considered a promising
development in this serious and deadly disease, which kills half of its
victims within 14 months of diagnosis. Peregrine believes that combined
positive data from this new study in India and ongoing U.S. glioblastoma
trials would provide a foundation for advancing Cotara into Phase lll
trials. In addition to the trial now underway in India, Cotara is currently
in a dosimetry and dose confirmation trial in glioblastoma patients at
leading U.S. academic brain cancer centers. Cotara has been granted orphan
drug status and fast track designation for the treatment of glioblastoma
multiforme and anaplastic astrocytoma by the U.S. Food and Drug
Administration.
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 Company will not be able
to enroll a sufficient number of patients to complete the clinical study,
the risk that enrollment will be slower than expected, the risk that the
results from the clinical study will not be consistent with the results
from the previous clinical studies supporting the potential efficacy of
Cotara in brain cancer, and the uncertainties associated with conducting
clinical studies in, and complying with the regulatory requirements of,
India. 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. 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