ANALIZE MEDICALE DE LABORATOR
Aici gasiti analizele medicale grupate pe categorii precum si detalii generale si specifice pentru categoriile respective.
Selectati o categorie din lista de mai jos:
Solutie antistress!
Construieste poduri :)
Prinde pisica neagra :)
Peregrine Pharmaceuticals Opens Enrollment In Phase II Clinical Trial Of Bavituximab In Patients With Advanced Breast Cancer
Peregrine
Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage biopharmaceutical
company developing targeted therapies for the treatment of cancer and
hepatitis C virus infection (HCV), announced that patient screening
has begun in a clinical trial designed to evaluate the safety and efficacy
of bavituximab in combination with chemotherapy in patients with advanced
breast cancer. The primary objective of the study is to assess the overall
response rate to the combination of bavituximab with docetaxel, a
chemotherapy drug commonly used in advanced breast cancer. The multi-center
clinical trial is being conducted in the Republic of Georgia.
In the trial's two-stage design, up to 15 patients with advanced breast
cancer will be enrolled initially. The study will then be expanded up to a
total of 46 patients if promising results are observed. Secondary
objectives include measuring time to tumor progression, duration of
response, overall patient survival and safety parameters. Patients may
continue to receive bavituximab alone after completion of chemotherapy as
long as the cancer does not progress and side effects are acceptable.
"We are delighted that patient screening has begun in this Phase II
study that provides us with an excellent opportunity to further evaluate
the potential efficacy of bavituximab in combination with chemotherapy in
treating breast cancer," said Steven W. King, president and CEO of
Peregrine. "This trial should allow us to build on the encouraging results
we observed in breast cancer patients in an earlier bavituximab combination
therapy study. We look forward to learning more about bavituximab's
potential in this important indication in the coming months as we advance
both this study and a second breast cancer trial evaluating a different
combination therapy regimen."
Tumor response in this Phase II 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.
The National Cancer Institute estimates that approximately 178,480 U.S.
women were diagnosed with cancer of the breast in 2007 and 40,460 women
died of the disease. 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.
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
received regulatory approval to conduct two additional Phase II trials to
study the anti-tumor effects of bavituximab in combination with
chemotherapy. These include a second breast cancer protocol assessing
bavituximab in combination with carboplatin plus paclitaxel and a non-small
cell lung cancer protocol assessing bavituximab in combination with
carboplatin and paclitaxel. 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 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, the risk that
the standard docetaxel response rate will not be improved as a result of
the combination therapy, 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 July 31, 2007 and the 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.
Peregrine Pharmaceuticals, Inc.
http://www.peregrineinc.com
Strãin deschide produse farmaceutice de înscriere în faza a II-a Bavituximab studiu clinic la pacienþi cu stadii avansate de cancer de sân - Peregrine Pharmaceuticals Opens Enrollment In Phase II Clinical Trial Of Bavituximab In Patients With Advanced Breast Cancer - articole medicale engleza - startsanatate