- OGXI (click for research page) successfully completed their SPA amendment with the FDA (click for PR) - so the protocol remains the same except that patients can have either docetaxel or cabazitaxel chemotherapy.
- OGXI also presented at Rodman and Renshaw conference on 9/13/11 (Click here for webcast directory and links to all of my notes)...here are a few notes:
--SYNERGY is primary registrational trial for cusirsen OGX-011, enrollment is moving along very nicely
--survival correlation w/ clusterin levels- what creates resistance to clusterin? what happens in nonresponsive tumors? Think about herceptin and HER2 expression. It doesn't matter so much where patients started. Clusterin is upregulated in repsonse to stress of treatment - we are trying to prevent the upregulation
--We are not exploring a diagnostic yet, data on clusterin levels is more to supplement the regulatory package