Peregrine
Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical
company developing monoclonal antibodies for the treatment of cancer and
hepatitis C virus (HCV) infection, announced that its Phase II
clinical protocol to study bavituximab in combination with the chemotherapy
drug docetaxel in patients with metastatic breast cancer has been approved
by the Drug Agency of the Ministry of Labour, Health and Social Affairs of
Georgia. The open label, multi-center safety and efficacy trial is expected
to begin enrolling patients by early 2008.
The primary objective of the trial is to assess the overall response
rate to the combination of bavituximab with docetaxel, a chemotherapy drug
commonly used in the treatment of metastatic breast cancer. Secondary
objectives include measuring time to tumor progression, duration of
response, overall patient survival and safety parameters. In the trial's
two-stage design, up to 15 patients with metastatic breast cancer will be
enrolled initially. The study will then be expanded up to a total of 46
patients if promising results are observed. The trial is expected to enroll
patients at a minimum of three clinical trial sites.
"We are eager to assess bavituximab's potential in Phase II combination
studies in a number of cancer indications, and we are very pleased to have
received prompt regulatory approval to proceed with this breast cancer
trial," said Steven W. King, president and CEO of Peregrine. "The clinical
sites in the Republic of Georgia that will be participating in assessing
bavituximab have extensive experience in conducting mid and late stage
cancer studies that adhere to FDA and international standards, and we look
forward to working with them to ensure the timely conduct of this important
Phase II trial."
Tumor response in this new study will be evaluated using Response
Evaluation Criteria in Solid Tumors (RECIST) parameters. The trial is being
conducted according to International Conference on Harmonization (ICH) and
Good Clinical Practices (GCP) standards.
According to the World Health Organization, metastatic breast cancer is
the most commonly diagnosed cancer in women, and is second only to lung
cancer as a leading cause of female cancer deaths. The National Cancer
Institute estimates that 178,480 U.S. women will be diagnosed with cancer
of the breast in 2007 and 40,460 women will die of the disease.
Bavituximab is a monoclonal antibody that binds to a phospholipid
called phosphatidylserine that is usually located inside normal cells, but
which becomes exposed on the outside of the cells that line the blood
vessels of tumors, creating a specific target for anti-cancer treatments.
Bavituximab is believed to help mobilize the body's immune system to
destroy the blood vessels needed for tumor growth and spread. In a Phase lb
trial in advanced cancer patients, bavituximab plus chemotherapy appeared
to have a safety profile consistent with chemotherapy alone and showed
positive signs of clinical activity, achieving objective response or
disease stabilization in 50% of the evaluable patients. A protocol for a
Phase II trial of bavituximab in combination with the chemotherapy drugs
paclitaxel and carboplatin in patients with metastatic breast cancer is
currently undergoing regulatory review in India. A protocol for a Phase II
trial of bavituximab in combination with the chemotherapy drugs paclitaxel
and carboplatin in patients with non-small cell lung cancer (NSCLC) is also
under regulatory review in India. Bavituximab is in clinical trials in the
U.S. in patients with advanced solid tumors and in patients co-infected
with HCV and HIV.
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 experience
delays or difficulties in enrolling patients in the study, and the risk
that the results from this trial will not be consistent with the results of
prior trials or preclinical studies. 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
quarterly report on Form 10-Q for the quarter ended July 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.
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