Peregrine Pharmaceuticals Receives Approval to Conduct a Phase II Trial of Bavituximab...

Peregrine Pharmaceuticals Receives Approval to Conduct a Phase II Trial of
Bavituximab in Patients With Non-Small Cell Lung Cancer
-Clinical Trial to Evaluate Anti-Tumor Activity of Bavituximab in Combination
with Carboplatin and Paclitaxel-

TUSTIN, Calif., Jan. 22 /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 that its Phase II clinical
protocol to study bavituximab in combination with chemotherapy in patients
with non-small cell lung cancer (NSCLC) has been approved by the Drug
Controller General of India (DCGI). The primary objective of the multi-center
clinical trial is to assess the overall tumor response rate in NSCLC patients
treated with the combination of bavituximab and carboplatin plus paclitaxel.
In the trial's two-stage design, up to 21 patients with NSCLC will be
enrolled initially. The study will then be expanded up to a total of
49 patients if promising results are observed in the initial cohort.
Secondary objectives of the study include time to tumor progression, duration
of response, overall patient survival and safety parameters. Patients may
continue to receive bavituximab as long as the cancer does not progress and
side effects are acceptable.
"This phase II trial represents an excellent opportunity for us to
evaluate the potential activity of adding bavituximab to a standard regimen of
carboplatin plus paclitaxel in NSCLC, a common and deadly cancer that still
lacks effective treatment options," said Steven W. King, president and CEO of
Peregrine. "With this approval in hand, we can now proceed with final
preparations for the trial and look forward to study initiation in the near
future."
Tumor response in this 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.
Lung cancer kills more Americans than any other type of cancer. According
to the American Cancer Society, in the U.S. lung cancer is the second most
commonly diagnosed cancer in men and women and is the leading cause of cancer
deaths. It estimates that there were approximately 213,400 new cases of lung
cancer and an estimated 160,400 lung cancer deaths in the U.S. in 2007.
Non-small cell lung cancer, or NSCLC, is the most common type of lung cancer.
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 pilot 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. Peregrine has filed three Phase II cancer
protocols to study bavituximab in combination with chemotherapy. In addition
to the NSCLC protocol approval announced today, a protocol to study
bavituximab in combination with docetaxel in patients with advanced breast
cancer has been approved in the Republic of Georgia and is expected to begin
shortly, and a second breast cancer protocol to study bavituximab in
combination with carboplatin plus paclitaxel is expected to be approved soon
in India. Bavituximab is also in Phase I 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 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 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 October 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.
Contacts:
GendeLLindheim BioCom Partners
Investors Media
info@peregrineinc.com Barbara Lindheim
(800) 987-8256 (212) 918-4650

SOURCE Peregrine Pharmaceuticals, Inc.

investors, GendeLLindheim BioCom Partners, 1-800-987-8256,
info@peregrineinc.com, or media, Barbara Lindheim, +1-212-918-4650, both for
Peregrine Pharmaceuticals, Inc.