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Findings Suggest ABRAXANE Avastin Combination Overcomes Newly Discovered Phenomenon of Reactionary Angiogenesis
Results Presented at the 2008 American Association for Cancer Research (AACR) Annual Meeting
Abraxis BioScience, Inc. (NASDAQ:ABII), an integrated, global biotechnology company, today presented preclinical data demonstrating the effect of ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound) in combination with Avastin® (bevacizumab) to eradicate large-sized (up to 600 mm3) orthotopic breast tumors and lymphatic and systematic metastasis at the American Association for Cancer Research (AACR) Annual Meeting held April 12-16, 2008 in San Diego, California (Poster No. 4021, Volk: Eradication of large orthotopic breast tumors and metastasis by combined nab-paclitaxel and bevacizumab therapy). The findings presented at AACR suggest a novel mechanism through which ABRAXANE can overcome a newly discovered phenomenon of reactionary angiogenesis.
These results confirm a synergistic effect of ABRAXANE (nab-paclitaxel) and Avastin combination on metastasis in breast cancer previously presented orally at the San Antonio Breast Cancer Symposium in December 2007.
The dosage of ABRAXANE and the timing of Avastin administration were modified in this study to achieve sustainable regressions of large-sized primary tumors (average size 450 mm3) as well as lymphatic and lung metastases. Luciferase-tagged MDA-MB-231-Luc+ human breast carcinoma cells were implanted into the mammary fat pads of preclinical models and allowed to reach an average size of 450 mm3 (range 350-600 mm3). Models were then treated with ABRAXANE at 10 or 30 mg/kg on the qdx5 schedule for 1, 2 or 3 cycles separated by one week. In combination groups, Avastin (4mg/kg) was administered either concurrently with ABRAXANE or post-ABRAXANE treatment; and either continued for the duration of the experiment or discontinued after cessation of ABRAXANE therapy. Tumor growth was monitored for approximately 100 days after implantation, and organs were analyzed for luciferase activity representing metastatic spread.
After treatment with two cycles of ABRAXANE and Avastin given concurrently at 30 mg/kg and 4 mg/kg, respectively, 100 percent of pre-clinical models were free of metastasis in lymph nodes and lungs as determined by measuring luciferase activity and complete regressions of the large orthotopic primary MDA-MB-231-Luc+ tumors were achieved. Three cycles of combined therapy with ABRAXANE at 10 mg/kg resulted in 98 percent reduction in averaged metastatic burden and 80 percent regression of the primary tumors. Avastin effect was optimal when administered concurrently with ABRAXANE and continued for the duration of the experiment. Avastin administered sequentially after ABRAXANE showed no benefits of the combined therapy. No toxicity was observed in any of the treated pre-clinical models.
These findings show that large-sized (up to 600 mm3) orthotopic tumors and lymphatic and systemic metastases in pre-clinical models can be eradicated using repetitive cycles of ABRAXANE at 30 mg/kg given concurrently with Avastin at 4 mg/kg.
The U.S. Food and Drug Administration (FDA) approved ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
ABRAXANE® is a solvent-free chemotherapy treatment option for metastatic breast cancer. Developed using Abraxis BioScience's proprietary nabTM technology platform, ABRAXANE is a protein-bound chemotherapy agent, which combines paclitaxel with albumin, a naturally-occurring human protein.
ABRAXANE is currently in various stages of investigation for the treatment of the following cancers: first-line metastatic breast, non-small cell lung, malignant melanoma, pancreatic, gastric, and head and neck.
The most serious adverse events associated with ABRAXANE in the randomized metastatic breast cancer study for which FDA approval was based included neutropenia, anemia, infections, sensory neuropathy, nausea, vomiting and myalgia/arthralgia. Other common adverse reactions included anemia, asthenia, diarrhea, ocular/visual disturbances, fluid retention, alopecia, hepatic dysfunction, mucositis and renal dysfunction. For the full prescribing information for ABRAXANE, including Boxed Warning, please visit www.abraxane.com.
ABRAXANE was developed by Abraxis BioScience. ABRAXANE is marketed in the United States under a co-marketing and sales agreement between Abraxis and AstraZeneca Pharmaceuticals LP.
About Abraxis BioScience, Inc.
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 the world's first and only protein-bound nanoparticle 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. Abraxis trades on the NASDAQ Global Market under the symbol ABII. For more information about the company and its products, please visit www.abraxisbio.com.
Avastin® is a registered trademark of Genentech.
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Abraxis BioScience, Inc.
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