�Peregrine
Pharmaceuticals, Inc. (Nasdaq: PPHM) proclaimed that affected role screening
and dosing has begun in a Phase II trial designed to evaluate the safety
and efficacy of bavituximab in combination with chemotherapy in patients
with advanced chest cancer. The new trial run is the second Phase II study
evaluating bavituximab in advanced breast cancer patients, and Peregrine
too is conducting a third base Phase II combination therapy trial of
bavituximab in non-small cell lung cancer the Crab (NSCLC) patients. The principal
objective of the newfangled breast cancer the Crab study is to appraise the boilers suit tumor
response rate to the combination of bavituximab with carboplatin and
paclitaxel.
"The combination of bavituximab with the chemotherapy drugs carboplatin
and paclitaxel performed well in an earlier Phase I study, and we look
forward to learning more about bavituximab's potential in this larger
breast cancer study," said Steven W. King, chair and CEO of Peregrine.
"With trey Phase II studies now underway, we look forrard to significant
clinical data being generated throughout the rest of this year."
In the trial's two-stage design, up to 15 patients with advanced breast
cancer will be enrolled initially. The study volition then be expanded up to a
total of 46 patients if promising results are observed. Secondary
objectives of the trial include measure time to tumor patterned advance,
duration of response, boilers suit patient selection and rubber parameters. Tumor
response will be evaluated using Response Evaluation Criteria in Solid
Tumors (RECIST) parameters. Patients may continue to receive bavituximab
unequaled after completion of chemotherapy as long as the cancer does not
procession and side effects are acceptable. The trial is being conducted in
India according to International Conference on Harmonization (ICH) and Good
Clinical Practices (GCP) standards.
Peregrine recently reported that a Phase II trial assessing the
combination of bavituximab and docetaxel in patients with metastatic breast
cancer had achieved the pre-specified Stage A primary endpoint needed to
expand the trial to the second stage. Seven of the 14 evaluable patients
achieved partial neoplasm responses and seven had stable disease at week eight
according to RECIST criteria.
"Bavituximab showed bright signs of anti-tumor action in
metastatic breast cancer patients in combination with chemotherapy in a
clinical study we helped impart last class," said Dr. Raghunadharao
Digumarti, professor of medical oncology at the Nizams Institute of Medical
Sciences in Hyderabad, India and a principal investigator of the
bavituximab Phase II breast cancer test. "We seem forward to assessing the
results from this test in a larger population of patients with boob
cancer, the most unremarkably diagnosed cancer in women worldwide."
According to the World Health Organization, white meat cancer is the most
commonly diagnosed cancer in women, and is second only to lung crab as a
leading cause of female cancer deaths. The National Cancer Institute
estimates that approximately 182,460 U.S. women will be diagnosed with
white meat cancer in 2008 and 40,480 women will die of the disease.
Bavituximab is a monoclonal antibody antibody that binds to the cellular
membrane constituent phosphatidylserine (PS) that is usually located inside
cells, but which becomes exposed on the outside of the cells that line the
stock vessels of tumors, creating a specific target for anti-cancer
treatments. By binding to PS, bavituximab is believed to help circulate the
body's immune arrangement to demolish the tumor and the tumor rip vessels.
Bavituximab currently is in 2 separate Phase II combination therapy
trials for the treatment of advanced tit cancer and a Phase II
combination therapy trial for the treatment of non-small cell lung genus Cancer.
Peregrine of late reported that a Phase II run assessing the combination
of bavituximab and docetaxel in patients with metastatic breast cancer had
achieved the pre-specified Stage A master efficacy termination needed to
expand the trial to the second stage. A Phase I bavituximab monotherapy
trial in advanced firm cancers is also continuing.
About Peregrine Pharmaceuticals Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a
portfolio of advanced product candidates in clinical trials for the
handling of cancer and hepatitis C computer 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 manufacture capabilities through and through its altogether owned underling
Avid Bioservices, Inc. (hypertext transfer protocol://www.avidbio.com), which provides developing
and bio-manufacturing services for both Peregrine and remote customers.
Additional information about Peregrine pot be found at
hypertext transfer protocol://www.peregrineinc.com.
Safe Harbor Statement: Statements in this push release which are non
purely diachronic, including statements regarding Peregrine
Pharmaceuticals' intentions, hopes, beliefs, expectations, representations,
projections, plans or predictions of the future ar 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, the risk of infection that
the standard carboplatin and paclitaxel response rate will not be improved
as a result of the combination therapy, and the peril 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 existent
results could differ materially from those in whatever such modern
statements. Factors that could cause actual results to differ materially
include, merely are non limited to, uncertainties associated with completing
preclinical and clinical trials for our technologies; the early stage of
merchandise development; the significant costs to rise our products as all
of our products are currently in development, presymptomatic studies or
clinical trials; obtaining extra financing to support our operations
and the development of our products; obtaining regulatory approval for our
technologies; hoped-for timing of regulatory filings and the potential
success in gaining regulatory favourable reception 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, 2008. The company cautions
investors not to place undue reliance on the advanced statements
contained in this press handout. Peregrine Pharmaceuticals, Inc. disclaims
any obligation, and does not undertake to update or revise any
forward-looking statements in this exhort release.
Peregrine Pharmaceuticals, Inc.
http://www.peregrineinc.com
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