RE: AGM ?........k3 K3....." this is a IIa study and it is hard to establish the parameters of what is worthy to carry on to a phase 2b study. The interim results are from an extremely small sampling, albeit apparently very positive" end quote
Actually the parameters for TypeI are already established. Endicronologists (and that includes the ones consulting the FDA) consider anything that induces a decrease in Daytime Insulin Usage of 20% plus to be Therapeutically, Clinically,Statistically Significant. 20% decrease DIU may not cut it as the final number in a Phase2 seeing as though dosing will be targeted to improve efficacy.
...The interim data for Typel showed a 35%-75% (actually 78% they must have rounded off) decrease in DIU in a blinded 3 of 4 patients......more specifically 3 of the FIRST 4 representing a trial designed Placebo Control, Single Group Assignment, which would show efficacy in 100% of Drug Recipients and 1 Placebo Recipient showing zero% efficacy.
TypeII interim data wasn't available last time but you can bet your boots if there is Islet Neogenisis in 100% of the first TypeI Group there will be Islet Neogeisis in the TypeII Trial and should improve the body's ability to control glucose which will be assessed by the oral glucose tolerance test (OGTT). I do not know the Endicinologists ideas of what is considered therapeuticaly significant for the decrease in use of Metformin and/or TZD but I PREDICT we may see some potential to see decreases in the 100% range.
Pretty darn blockbuster results even just for one single group. If total data is even close we've got a winner on quite a few fronts when even just taking regulatory hurdles into consideration. The Novo deal is pretty straight forward.....if they don't want it someone else will and fast.....and for even more money now that efficacy will have been shown prior to a phase 2b.
Dr. Cruz has been designing the phase 2b since Dec. of last year when interim data showed efficacy and will be ready to move forward at lightening speed should the opportunity present itself for TTH to Sponsor the Trials poste haste.