Replies to post #4770 on GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Re: ART-123

>At N=50 (in the subgroup), the lack of stat sig. mortality is not surprising…<

Agreed; however the very modest absolute survival difference (6.6 percentage points in the sepsis group and 0.8 percentage points in the cancer group) was unimpressive.

>…the overall DIC benefit looked promising.<

Improvement in DIC is a surrogate endpoint that will not in itself be sufficient for product approval in major jurisdictions such as the US and the EU.

>since ART-123 works on the APC pathway would this be expected to behave similarly to Xigris (recombinant APC)?<

I was wondering the same thing, but I think the answer is No. I.e., we should not expect ART-123 to have a similar outcome to Xigris just because both drugs involve the protein C pathway. Regards, Dew