Post by
narcissist on Jan 20, 2012 1:15am
Voclosporin and Side Effects
I mentioned in a previous post that voclosporin's advantage over the competition turns on its relative safety. And it's safety that will propel this calcineurin inhibitor to the head of the pack. Obviously this needs to be demonstrated convincingly in clinical trial. So far the data is not sufficiently rigorous to bring this drug to approval. For small investors like those of us who have gambled on this investment it would be helpful to have more than a wish and a prayer to run with. I think we do. We don't need an advanced degree in biochemistry to get a fix on the chemistry involved. But it is the chemistry that makes voclosporin superior to the competition. Voclosporin is a complex molecule. But it has been engineered - rather brilliantly I think - with the addition of one carbon molecule in a key location which allows the drug to do two things more efficiently than cyclosporine or tacrolimus: 1) it's more potent - that is it binds more effectively - potentially requiring a lower dosage, and 2) when it breaks down, the potentially toxic byproducts - the so-called metabolites - are eliminated much more quickly. That's the theory. And, all of this has been demonstrated convincinly in animal studies. Because the breakdown products of the drug are eliminated much more quickly and efficiently, those toxic elements are less likely to "poison" the patient. Theory and aniumal studies are one thing - but what about real world studies on human beings? So far the theory and results do seem to match - but the numbers of patients involved and the lengths of the studies are not large enough or long enough to meet regulatory requirements. But the Phase IIb studies do not contradict the theory or the promise. Clearly these facts, and the results so far have been convincing enough to draw the interest of several major players in the Swiss Pharma industry, as well as in Korea and China. We just need to hold on and wait this out. In any event, these are the basic elements that will determine the future of this investment. There well might be counter-arguments out there suggesting other interpretations of the data - but I haven't seen any.