- Pre-Specified Primary Efficacy Endpoint Met in Stage 1 of Two-Stage Study - - 100% of Evaluable Patients to Date Continue to Show Objective Tumor Response or Stable Disease -
TUSTIN, Calif., July 2 /PRNewswire-FirstCall/ -- Peregrine
Pharmaceuticals, Inc. (Nasdaq: PPHM) today reported that its lead product
candidate bavituximab achieved the pre-specified Stage 1 primary endpoint in
its ongoing Phase II clinical trial in patients with metastatic breast cancer.
The trial is an open-label, Simon two-stage design to evaluate the safety and
efficacy of a combination of bavituximab and docetaxel in metastatic breast
cancer patients. Fourteen of the 15 patients enrolled in Stage 1 were deemed
evaluable for tumor response, with seven achieving partial tumor responses and
seven having stable disease at week eight according to RECIST criteria. All
14 of the evaluable patients remain in the study and are continuing to receive
treatment, along with continuing assessments of tumor response. With the
Stage 1 primary endpoint of six or more objective tumor responses achieved,
the design of the clinical trial now allows for an additional 31 study
patients to be enrolled.
"We are very pleased with the early positive results from this Phase II
breast cancer study," said Steven W. King, president and CEO of Peregrine.
"We are particularly encouraged by the fact that at an early time point of
eight weeks, half of the patients had achieved objective tumor responses.
Equally encouraging is that with patients now out over four months since the
start of the study, none have shown tumor growth or disease progression. As
these patients continue on treatment, we will continue assessing them for
signs of anti-tumor activity. We look forward to sharing more data from this
study as patient treatment and follow-up progress."
The primary objective of the multi-center Phase II clinical trial is to
assess overall tumor response rate. Secondary objectives include measuring
time to tumor progression, duration of response, overall patient survival and
safety parameters. All tumor responses in the trial are being evaluated using
Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Patients may
continue to receive bavituximab as solo therapy after completion of
chemotherapy as long as the cancer does not progress and side effects are
acceptable. The trial is being conducted in the Republic of Georgia according
to International Conference on Harmonization (ICH) and Good Clinical Practices
(GCP) guidelines.
According to the RECIST criteria, patients are categorized as having
"stable disease" ("SD") if they have less than a 20% increase to a 30%
reduction in the sum of the target lesions, and they are categorized as having
a "partial response" ("PR") if they experience greater than a 30% reduction in
the sum of target lesions. In addition, to be assigned a status of SD or PR,
patients cannot have the appearance of any new lesions.
According to the World Health Organization, 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 approximately 182,460 U.S. women will be diagnosed with breast cancer in
2008 and 40,480 women will die of the disease in the U.S. alone.
Bavituximab is a monoclonal antibody that binds to the cellular membrane
component phosphatidylserine (PS) that is usually located inside 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. By binding
to PS, bavituximab is believed to help mobilize the body's immune system to
destroy the tumor and the tumor blood vessels. Bavituximab currently is in two
Phase II combination therapy trials for the treatment of metastatic breast
cancer and for the treatment of non-small cell lung cancer (NSCLC). A second
Phase II combination therapy study in breast cancer patients is expected to
begin soon. Data presented at the 2008 ASCO annual meeting showed that half
of evaluable patients in a Phase Ib trial of bavituximab plus chemotherapy
achieved an objective tumor response or stable disease after eight weeks of
dosing, that the safety profile of bavituximab and chemotherapy appeared
consistent with chemotherapy alone and that the pharmacokinetic properties of
bavituximab were not affected by co-administration with conventional
chemotherapies. A Phase I bavituximab monotherapy trial in advanced solid
cancers is continuing.
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. (www.avidbio.com), which provides development and bio-
manufacturing services for both Peregrine and outside customers. Additional
information about Peregrine can be found at 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 results of the subsequent stage for this trial will not be
consistent with the results of the first stage. 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 the quarterly report on
Form 10-Q for the quarter ended January 31, 2008. 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.
