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The information contained in this press release is as of the date of this release. Abraxis assumes no obligations to update any forward looking statements contained in this press release as the result of new information or future events or developments.
Abraxis BioScience Inc ABRAXANE Meets Primary Endpoint in Phase 3 Trial for Advanced Non Small Cell Lung Cancer
ABRAXANE can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with ABRAXANE.
ABRAXANE contains albumin (human), a derivative of human blood.
It is recommended that nursing be discontinued when receiving ABRAXANE therapy.
Men should be advised to not father a child while receiving treatment with ABRAXANE.
"NSCLC is the most common form of lung cancer and is very difficult to treat. This protein bound chemotherapy agent combines paclitaxel with albumin, a naturally occurring human protein. By wrapping the albumin around the active drug, ABRAXANE can be administered to patients at higher doses, delivering higher concentrations of paclitaxel to the tumor site than solvent based paclitaxel. In the randomized controlled trial, patients were excluded for baseline serum bilirubin >1.5 mg/dL or baseline serum creatinine >2 mg/dL.
This trial is the subject of a special protocol assessment (SPA) with the FDA, which means that the design, clinical endpoints and statistical analyses of the trial have been previously agreed upon by the FDA. Specifically, the FDA agreed that the demonstration of a statistically superior response rate of the ABRAXANE and carboplatin combination over the Taxol and carboplatin combination would be sufficient to submit a supplemental new drug application (sNDA)(as a 505(b)(2) submission) for approval of ABRAXANE in combination with carboplatin for first line NSCLC.
The statements contained in this press release that are not purely historical are forward looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward looking statements in this press release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the clinical development plan, and the timing and scope of clinical studies and trials, for ABRAXANE and the global commercialization of ABRAXANE. Because these forward looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward looking statements. Additional relevant information concerning risks can be Lv Belt Price found in the company's Annual Report on Form 10 K for the year ended December 31, 2009 and in other documents it has filed with the Securities and Exchange Commission.
patients and has important implications not only in late stage cancer but also in earlier stages of the disease," Socinski said. The data will be submitted for consideration as a late breaking presentation at the upcoming American Society of Clinical Oncology (ASCO) meeting.
peripheral blood cell counts be performed on all patients receiving ABRAXANE.
ABRAXANE therapy should not be administered to patients with metastatic breast cancer who have baseline neutrophil counts of less than 1,500 cells/mm3. It is recommended that frequent Ferragamo Belt Gold Buckle
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Abraxis BioScience is a fully integrated global biotechnology company dedicated to the discovery, development and delivery of next generation therapeutics and core technologies that offer patients safer and more effective treatments for cancer and other critical illnesses. The company's portfolio includes chemotherapeutic compound (ABRAXANE), which is based on the company's proprietary tumor targeting technology known as the nab platform. The first FDA approved product to use this nab platform, ABRAXANE, was launched in 2005 for the treatment of metastatic breast cancer and is now approved in 39 countries. The company continues to Ferragamo Belts Black
expand the nab platform through a robust clinical program and deep product pipeline. Abraxis trades on the NASDAQ Global Market under the symbol ABII.
Caution should be exercised when administering ABRAXANE concomitantly with known substrates or inhibitors of CYP2C8 and CYP3A4.
LOS ANGELES (BUSINESS WIRE) Abraxis BioScience, Inc. (NASDAQ:ABII News) today announced that its randomized registrational Phase 3 clinical trial comparing ABRAXANE (protein bound paclitaxel) with Taxol (paclitaxel) injection, both in combination with carboplatin, met the study's primary endpoint by demonstrating that ABRAXANE showed a significant improvement in overall response rate as compared to Taxol, in the first line treatment of patients with advanced non small cell lung cancer (NSCLC), as assessed by independent radiologist review. It is one of the largest NSCLC clinical studies to be conducted. "This is exciting news for lung cancer Ferragamo Belt Grey
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