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Positive Results from Phase 2 Clinical Study of NKTR-102 in Metastatic Breast Cancer Presented in Oral Session at the ASCO 2011 Breast Cancer Symposium
Date:9/9/2011

and capecitabine in either the adjuvant or metastatic setting.  Patients will be randomized on a 1:1 basis to receive single-agent NKTR-102 once every three weeks or a single agent of physician's choice.  The primary endpoint of the study will be overall survival, and secondary endpoints will include progression-free survival and objective tumor response rates.  The global BEACON study, which will include over 130 investigator sites, is expected to begin in December 2011.

About Metastatic Breast CancerMore than one million women worldwide are diagnosed with breast cancer globally every year(1).  The chance of developing invasive breast cancer at some time in a woman's life is a little less than one in eight (12%).  There are approximately 200,000 new cases of breast cancer in the United States and 430,000 in Europe each year.(2)  Metastatic breast cancer refers to cancer that has spread from the breast to distant sites in the body.  

Anthracyclines and taxanes (AT) are the most active and widely used chemotherapeutic agents for breast cancer, but the increased use of these agents at an early stage of disease often renders tumors resistant to these drugs by the time the disease recurs, thereby reducing the number of treatment options for metastatic disease.  Drugs used to treat patients who progress following AT treatment can have response rates as high as 20-30%; however, resistance develops rapidly and new agents with different mechanisms of action, such as topoisomerase I inhibitors, are needed to allow novel ways to overcome the problem of drug resistance.(3)  There are currently no FDA-approved topoisomerase I inhibitors to treat breast cancer.

About NKTR-102NKTR-102 is a next generation topoisomerase I inhibitor with a unique pharmacokinetic profile that provides a continuous exposure to active drug with reduced peak concentrations. NKTR-102 is a new chemical entity designed by
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SOURCE Nektar Therapeutics
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