some history from July 2012 merger report, re IV vs SC dosing:
"Patients on the Trial were randomized to receive 75mg of XToll®, 25mg of XToll®
or placebo via subcutaneous injections twice-weekly for 24 weeks. "
"We note from Table 5.1 above that the primary endpoint of the Trial was not met as the difference
in ACR20 mean values of the XToll® treated patient groups and the placebo treated patient groups
was not statistically significant. The Trial did however show statistically significant or clinically
meaningful improvement in a number of other measures of improvement, or secondary endpoints,
in RA signs and symptoms."
"The review suggested that subcutaneous dosing with XToll® in clinical trials has a low probability of
meeting meaningful clinical endpoints and that further trials involving solely subcutaneous dosing
should only be considered if a more suitable reformulated and/or reformatted form of XToll® is
available. It was acknowledged that the time and money required to do this makes it more sensible
to focus development of XToll® on alternative indications where the unmet need is such that
relatively frequent dosing and/or intravenous dosing is acceptable to patients and physicians. "
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some history from July 2012 merger report, re IV vs SC...
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