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Andy Grove is doing just that at UCSF; they designed the virus vector after studying the Amgen records within five years of their aborted trials. That is being used in the Ceregene trials and will be used in the NIH GDNF trials.
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Laura
I am interested in this information you posted . If you have a reference or source where you got this info, could you please post it? As I am looking into gene therapy-based therapeutics, it seems like AAV vector is the most often used one and has been shown to be safe in several studies. Though NIH's gdnf trial says it is with AAV, it was not clear if it is the same/similar to the one used in ceregne trials. I was just about to send letters to NIH and PCORI about this matter. My specific questions are:
Is NIH using the same AAV vector as the one used in Ceregene trials?
If so, all the relevant protocols, assays for testing antibodies etc., are rather should have been approved by the FDA. Ceregenes studies already established this vectors safety.
If so: Why is NIH taking so long to start GDNF clinical trials? I wanted to see if I can get a straight forward response from the NIH.
If not, is there anything PCORI (since it is the patient centered arm of Human Health Services ) can do about this issue.
Your comment caught my attention and it is just what I was looking for. Thanks
Girija