Replies to post #141866 on Biotech Values

[biotech jim]

Is it safe to assume that AZN/RIGL incorporated a radiographic study into the ongoing pivotal fostamatinib trials?

I have not been following RIGL closely for the past 2 years. But, I do know that Mike Weinblatt, MD and past president of the American College of Rheumatology, is an advisor for fostamatinib clinical trials. He is well-versed in the agency requirements as he has been involved in both TNF sequesterer trials and B-cell relevant RA studies (with abatacept).

So, I can only conclude that one of the registration studies will have a radiographic endpoint.

[genisi]

Is it safe to assume that AZN/RIGL incorporated a radiographic study into the ongoing pivotal fostamatinib trials?

Yes, see the 2nd primary outcome endpoint in the phase III trial:

Proportion of patients with ACR20 compared to placebo (ACR20 = American College of Rheumatology 20% response criteria) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Change from baseline to week 24 in mTSS (mTSS = radiographic modified total Sharp score) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

http://clinicaltrials.gov/ct2/show/NCT01197521