lost in translation : ClarificationHere's some clarification regarding the Canada based rAAT trials that I find quite compelling :
The recombinant form of alpha-antitripsin (rAAT) did not exist in 1990 when the original study was done to test the efficacy of AAT specifically for atopical dermatitis.
Unlike the recent Canadian rAAT trials that used a new transport mechanism, ( I honestly wasnt clear if they said it was a gel or ointment ) the clinically accepted studies performed in the 90's were done with an "artisanal saline solution". In some cases the patient would wear occlusive gloves to ensure inclusion of the AAT compound... basically ensuring that the AAT was penetrating the wounds or sores via the saline.
What Pierre said in the conference call is that the patients'
inclusion criteria were not necessarily the same as the original study specifically because of the differing transport mechanism. Its absolutely key that the AAT or rAAT penetrate the skin to be effective.
I must admit that this originally sounded to me as if they were grasping for something positive in an otherwise bad situation. Now that I have a bunch more facts in front of me, I honestly believe that this explanation potentially has alot of merit.
Consider this :
Prometic has proven definitively that the recombinant form of AAT and the plasma derived form are 99.8% identical.... Prometic concludes that the elastase inhibition, which is the mechanism of action of AAT or rAAT are virtually identical. In the 1990 study, AAT had statistically significant efficacy on atopic dermatitis.
DOESNT THIS MAKE IT UNLIKELY IN THE EXTREME THAT THE EFFICACY OF THE TWO FORMS OF AAT ARE STATISTICALLY DIFFERENT ? (which is really the basis of the whole trial ? )
Prometic's conclusion is that the different efficacy is a result of the differing inclusion of the compound into the skin NOT a difference in the efficacy between the virtually identical AAT and rAAT. THIS IS A HUGE point.
I will be interested to see what the company has to say about the process involved of proving this theory and what the time frame is. What are the regulatory requiremnts / process etc.
While I still maintain that rAAT is a relatively insignificant part of PLI's value drivers.... I'd say ... Stay tuned, this could get interesting again very quickly.