Peregrine
Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical
company developing targeted therapeutics for the treatment of cancer and
hepatitis C virus (HCV) infection, today announced initiation of patient
treatment in its Phase lb clinical trial to evaluate its lead
anti-phospholipid immunotherapy agent bavituximab given in combination with
common cancer chemotherapy agents. The trial is expected to enroll up to 12
patients at three clinical sites in India.
"We are very pleased that patient dosing is underway in this clinical
study of bavituximab in combination with commonly-used chemotherapy drugs
because preclinical studies support the concept that chemotherapy and
bavituximab should have synergistic anti-tumor effects," said Steven W.
King, president and CEO of Peregrine. "We are encouraged that the
regulatory and logistical requirements for initiating this trial have
proceeded so smoothly and we look forward to working with our clinical
sites to complete patient enrollment in this study over the next few
months. We believe the results from this study, in combination with data
from our ongoing U.S. cancer trial, will help support advancing bavituximab
into Phase II combination therapy cancer trials in 2007."
The Phase Ib trial is designed to test the safety and tolerability of
bavituximab over an 8-week administration period when given with standard
chemotherapy regimens including docetaxel, gemcitabine and
carboplatin/paclitaxel. These regimens are commonly used for treating major
cancer types, including breast, lung and pancreatic cancer, and patients
with these various types of cancer are potentially eligible for the trial.
Study endpoints include safety and drug pharmacokinetics. Patients will
also be evaluated for tumor response according to Response Evaluation
Criteria in Solid Tumors (RECIST) criteria, although this assessment is not
a formal endpoint of the study. Patients will be followed for an additional
four weeks after their last dose of bavituximab and may continue with
chemotherapy according to standard-of-care guidelines. The trial is being
conducted according to International Conference on Harmonization (ICH) and
Good Clinical Practices (GCP) guidelines.
Preclinical studies have confirmed that bavituximab acts
synergistically when administered in combination with chemotherapy in major
tumor types. Preclinical studies presented at the AACR annual meeting
showed the potential of a bavituximab equivalent plus chemotherapy or
radiation to increase survival in resistant breast and brain cancer, a very
positive result in these models of advanced disease. A study published in
the International Journal of Cancer demonstrated that a bavituximab
equivalent given in combination with gemcitabine showed encouraging
efficacy in animal models of pancreatic cancer, including reductions in
metastatic disease, and an article in Cancer Research reported that a
bavituximab equivalent plus docetaxel inhibited tumor growth by 93% in a
model of advanced breast cancer.
Bavituximab is currently in clinical trials in the U.S. for the
treatment of solid tumors and chronic hepatitis C infection. Clinical data
to date has shown that bavituximab is generally safe and well tolerated.
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 five separate clinical trials 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 previous clinical studies of bavituximab or the results from the
preclinical studies supporting the combination therapy regime 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, 2006 and
the quarterly report on Form 10-Q for the quarter ended July 31, 2006. 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