RE: Why Develop Regenerative Medicine??
Why Develop Regenerative Medicines...........
Endicrinologists consider any DB therapy that can reduce insulin usage by over 20% to be Statistically and Therapeutically Significant......to be possibly life changing due to the positive effect it will have on the DB Complications.
Our therapy E1-INT has shown up to 78% decrease in daytime insulin usage in Humans in interim data released to date. The lowest was 35%. This is in the all important Phasell Trials for Typel and Type2 recently completed and now being unblinded. Soon to be released!!
Primary endpoints are Safety and Tolerability and there will be some issues with tolerability in the Type2 but these issues were addressed early in the trial with the very first patients. Weight based dosing essentially overdosed (for lack of a better description) the patients. Being that Type2 patients are typically obese in varying degrees, standardized adult dosing solved this problem. Simply put.....just because a person weighs more than average (and these patients did!) does not mean their pancreas or other internal organs require additional dosage. This will be reflected in the final data.
Typel had early dropout but this was solved by Titrating up the Doses and no further adverse events were observed after this re: interim data. This will be reflected in the final data.
Secondary Endpoints include efficacy which has been described as nothing less than Block-Buster........and this is what really matters in the end because there will be Phasellb Trial/s anyways.
For me the efficacy will offset any adverse events simply because these trials seemed to be more of a learning experience very early on in the Trials for the dosing regime more than anything......but thats just me.
Others will shy away because of this and may bail but thats OK.......let them. They are the weak hands that are left here..........Many will be in the wings waiting for such weakness........Many Many Many with Deep Deep Deep pockets, interested in the future. A bright future at that!!