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Regulatory News: Article   Printable Version 


Regulatory News Article

OGX-011 Receives Fast-track Status

The U.S. Food and Drug Administration (FDA) recently granted OncoGenex Pharmaceuticals fast-track designation for their investigative agent OGX-011 (custirsen sodium) for the treatment of prostate cancer. Specifically, the designation includes the use of OGX-011 in combination with Taxotere® (docetaxel) for the treatment of progressive, metastatic prostate cancer.

OGX-011 is designed to inhibit clusterin, a protein that is associated with resistance to treatment.

OGX-011 is currently in five Phase II clinical trials including prostate, lung, and breast cancers. The fast-track designation comes prior to the initiation of a planned Phase III trial evaluating OGX-011 in hormone-refractory prostate cancer.



© 1998-2007 OncoEd.com All Rights Reserved.

These materials may discuss uses and dosages for therapeutic products that have not been approved by the United States Food and Drug Administration. All readers should verify all information and data before administering any drug, therapy or treatment discussed herein. Neither the editors nor the publisher accepts any responsibility for the accuracy of the information or consequences from the use or misuse of the information contained herein.
© 1998-2007 OncoEd, Inc  All Rights Reserved.

These materials may discuss uses and dosages for therapeutic products that have not been approved by the United States Food and Drug Administration. All readers should verify all information and data before administering any drug, therapy or treatment discussed herein. Neither the editors nor the publisher accepts any responsibility for the accuracy of the information or consequences from the use or misuse of the information contained herein.




   




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