GTC Biotherapeutics (fka GTCB)

[valueHunter]

Merrimack RA Phase II (from ClinicalTrials.gov)

I was looking back on the details of the study (listed as 'no longer recruiting', http://tinyurl.com/y7lrz6 ). It was a reasonably large Phase II study (260 patients) performed in almost 40 centers. The study monitored patients on one of 3 doses (2.5, 7.5 and 20 Mg) of MM-093, and did not include a placebo arm. I know this is wild, biased speculation - but I think there is some non-negligible probability that they could demonstrate clear efficacy in such a study. While a placebo arm was not included, patients were required to be on a stable regime of methotrexate and folate (so before and after comparisons are possible). Looking back, I found a reference ( http://tinyurl.com/yxlhzn ; Motley Fool) describing Amgen's intention (based on FDA guidance) to submit their application for IL-1ra (Kineret) following phase II studies of RA patients. Does anyone remember (before I dig too much further) - did they indeed submit after phase II? The Motley Fool referenced their intention to do so in Q2 1999, but I didn't think Kineret was approved until late 2001 (am I wrong on that?).

As an aside - does anyone know the half-life of MM-093 in serum and the proposed dosing frequency? If you do know a number, please indicate if the half-life is for a native AFP isoform or MM-093. I haven't searched the literature yet, but I found a reference in the clinicaltrial.gov summary that one of the exclusion criteria was women planning to become pregnant within 4 weeks after the last study dose.

Thanks for your help.
VH