Linda H. said there is an upcoming phase I gene therapy trial being conducted by the.....are you ready.... NIH. 24 participants. I haven't looked it up yet so I don't have any sources. If anyone does, just add it and i will have more later.

This is encouraging because it's the NIH....but I'd like to know where the GDNF came from.....it's a gene not a pump infused protein. Well there are lots of things I'd like to know....the timing is right but don't know what the specs are.

let's hear what you know,
thanks, paula

I had the same question when this came up at the PAN Forum and kept forgetting to ask!

I'll try to find out.

This is what I remember from the presentation at the PAN Forum:

At the Emerging Therapies session at the PAN Forum, Dr. Howard Federoff spoke about research on AAV2 virus delivery of GDNF. This was the viral delivery method used in the phase II Ceregene trial. He said it would involve "Convection Enhanced Delivery" (method used in the phase I infused GDNF Un. of Kentucky trials, but not in Amgen's) It gets the GDNF into the brain more efficiently. Also said additional areas of the brain would be targeted. A NINDS consortium has been researchiing viral vector delivery of GDNF in animal models and will be conducting a phase I clinical trial, possibly in Fall 2009. Hopefully more details will be coming....

Anymore about this? It sounds like something Steve Gill from UK was working on, doesn't it? He stayed a lot out the fray, still wanted to use Amgen in some capacity - heard that quite awhile back tho.

How interesting it is going to be to learn. i'm glad to see it, but suffer from cognitive dissonance - not from PD, just from mankind's failure to launch or similarly, launch with failure to tell --Will the NIH be quick about it? Do we allow ourselves to think that this is real and sometime soon?

I'm including this article received from Carolyn in pipeline email that reveals more unenforced and ignored regulations. It is not connected to the GDNF trial. Just more watchdog info.

20 Mar 2009 http://www.medicalnewstoday.com/articles/142956.php

Although paying finder's fees to researchers and clinicians to identify study participants could compromise the recruitment process and harm human lives, many medical schools fail to address this conflict of interest in their Institutional Review Board (IRB) policies.

Leslie Wolf, an associate professor of law at Georgia State University, studied the IRB policies posted on the Web sites of 117 medical schools that received National Institutes of Health funding. Among the study's findings, Wolf revealed that less than half of the IRB policies discuss finder's fees or bonus payments as conflicts of interest, where research sponsors pay members of the research team or clinicians to identify potential participants or for meeting predetermined enrollment targets.

paula

Quote:

Originally Posted by LindaH This is what I remember from the presentation at the PAN Forum:

knowing how you hang on to my every word, you may have forgotten but back in June 2008 I posted:

"I have heard at a meeting of the Royal Medical Society that Neurosurgeon Stephen Gill at Frenchay (Bristol UK), one of the pioneers of the original GDNF trials, has developed his own delivery mechanism and is close to an agreement with Amgen to trial".

Perhaps this is it.

Take care, you are still my hero

Neil.

Neil,

Bless you for thinking I'm capable of remembering that far back...I remember that there was a gdnf gene released from Amgen but didn't remember that it was Gill. It's all making sense. Thank you and I do read and enjoy all of your posts because, along with whatever it is you are contributing, you do it with a good sense of humor.

paula

Bumping this up and recommending that you stay tuned. Linda H. has been doing some checking around and is putting it together. Steven Gill is involved, and one of the researchers goes back to GDNF pre-amgen ownership. Linda is writing up what she has learned and I'm writing this teaser because I am feeling genuine excitement and hope about this one right now...always with the question will it be available in time. Now how to get rid of the placebo surgery....one answer is to get into phase I.

paula