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Biotech / Medical : AMLN (DIABETES DRUGS)

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To: David Bogdanoff who wrote (989)	12/4/1997 4:33:00 PM
From: Cacaito	Read Replies (1) of 2173

David Bogdanoff: I think that the decrease insulin use in the Pranlintide group vs the increase insulin use in the placebo group is a great accomplishment if they did aim for it to begin with and have the data to prove it was all a pranlintide effect, especially if accompanied by improved metabolic control. But all this was not the case. Plus the lack of statistical significance in the main goal this is to improved metabolic control (as per HbA1c tests). To control for the insulin use in the ongoing studies could only be accomplished by study design, since the subjects are humans, and they must not be fixed into a drug regimen that do not allow for changes up or down on insulin dose (re D Right previous post)that are aim for their benefits. The priority is then excellence in study design, this is a simpler task now that they have the hard data from the previous experience. I will like to speculate in other areas. Emisphere Technologies (EMIS) is working with and oral heparin form, this is a peptide that is digested (like insulin or amylin) by intestinal enzimes. But they encapsulate it on a special formulation (I believe made of aminoacids) to avoid digestion. They recently published news sucess in a type III study on this heparin formulation. I think that at some point an oral formulation of amylin is possible with this or similar techniques. Cortecs (DLVRY) is working in a similar design but with insulin itself. Alkermes (ALKS) is working in long term controlled release of hormones encapsulated for single intramuscular injections to be given weekly or monthly instead of daily. Amylin could be suited to this type of delivery. Inhaled Therapeutics is working on hormone delivery by inhalation to the lungs. Could it be possible to have a single vial combination of insulin and amylin? Could it be possible to mixed the drugs in the syringes just before injection? Could it be possible for amylin to be delivered by skin patch? Amylin has a future in type I disease and probably in type II, an improved form of delivery will be imperative in the future. Just looking at the company in the meantime. I am considering buying it for the long term.

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