To all the patients, and their families and significant others, I have some very good news. We have all been waiting, painfully I know, for the green light to go into clinical trials. I just got word that the FDA has given us the go-ahead to proceed to clinical trials. To all of you who have been wondering how soon? the answer is now, more clearly, soon.
Please bear in mind that this is just the beginning. Not the beginning of our labors, certainly (which go back decades), but the beginning of the clinical undertaking. The whole project remains experimental, yet our hopes are running high. So, while this does not translate immediately into a treatment, it opens the door to that possibility. Our work is not done, and your waiting is not over, but this is a really wonderful day. I wanted to share it with all of you who have been hanging in there despite what must seem like a glacial, excruciatingly slow process. The reality is that things are moving quite rapidly for a process like this, and for that I need to thank all those who have made this happen: in the laboratory, in the generous financial support and as consultants and intermediaries of all stripes.
A big thanks to everyone at this momentous occasion: Completing the preclinical phase and beginning clinical investigation for this ongoing project.
Henry Klassen, MD, PhD
April 21, 2015