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Regulatory News: Article   Printable Version 


Regulatory News Article
IND Filed for SPI-3005

Sound Pharmaceuticals (SPI) has filed an investigative new drug (IND) application with the United States Food and Drug Administration (FDA) for their investigative oral agent SPI-3005 (ebselen). The IND is for use of SPI-3005 for the prevention of hearing loss (ototoxicity) induced by chemotherapy.

SPI-3005 has been designed to attenuate platinum or taxane-based chemotherapy ototoxicity without interfering with their effectiveness.

SPI-3005 will be tested in clinical trials including patients with advanced lung and head and neck cancer patients being treated with platinum-based chemotherapy.



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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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