Print

Print


I don't mean to dash anyone's hopes, but the GDNF that Amgen has licensed to AMT is a different form than that used in the previous clinical trials. The license is for the GDNF gene, AMT will try to develop a gene therapy treatment using an  AAV (virus) to deliver the gene into the brain. It is  indeed good news, but this gene delivery treatment is at the early stages of development and will likely take a number of years to reach clinical trials. 
 The previous trials, which were terminated by Amgen in Sept 2004 utilized a recombinant form of the GDNF protein, which was infused into the brain by a pump/catheter system. Have not heard anything about Amgen licensing this product to another company -- its still likely sitting on their shelves. Although amgen claimed the trial was not successful according to their statistical analysis, their conclusions have been challenged and many of the trial participants improved dramatically. Parkinson's advocates fought amgen for years to try to convince them to provide compassionate use of the treatment to the trial participants and to resume the research, but to no avail.
It was predicted that if the research on infused delivery had been continued, GDNF could have been available for clinical use by 2007!  You can read the whole saga in the book "Monkeys in the Middle :  How One Drug Company Kept a Parkinsons Disease Breakthrough Out of Reach" by Nick Nelson. It's available on Amazon. see: http://monkeysinthemiddle.com/ Also the Parkinson Pipeline Project has followed the issue -- see
http://pdpipeline.org/advocacy/gdnf_table.htm Linda

  



-- Sharon & Jim Le Blanc <[log in to unmask]> wrote:
This is great news. Glial Cell Derived Neutropic Growth Factor. Growing back 
what it can in the brain. Doesn't stop Parkinsons, but the testimonies I've 
read say those in the first study  felt the improvement long after they 
stopped taking GDNF.
Sharon


----- Original Message ----- 
From: "rayilynlee" <[log in to unmask]>
To: <[log in to unmask]>
Sent: Thursday, September 18, 2008 6:32 PM
Subject: Amgen's GDNF Gene resumes use in PD


> Source:  Viartis
> 18th September 2008 - News release
> AMGEN'S GDNF GENE RESUMES USE IN PARKINSON'S DISEASE
> The GDNF gene is claimed to contain the information for a protein 
> necessary for the development and survival of nerve cells. Several years 
> ago, Amgen's use of GDNF was being touted as a great breakthrough in 
> Parkinson's Disease. During Amgen's clinical trials of GDNF, patients were 
> claiming that their symptoms had been rid due to using it - even though 
> some of those patients had been taking the placebo instead. Amidst 
> widespread protests, Amgen ceased its use of GDNF altogether due to 
> studies showing that it caused toxicity in animals. The patients' 
> experiences were subsequently detailed in "Monkeys in the Middle". 
> Amsterdam Molecular Therapeutics (AMT) have just announced that it has 
> obtained a license from Amgen to use their GDNF gene for the development 
> of a gene therapy treatment for Parkinson's disease. For more information 
> go to AMT. In theory, GDNF could biochemically increase somebody's ability 
> to produce their own dopamine. However, an animal study showed that this 
> effect would reverse over time. Since the Amgen clinical trial, in two 
> small independent open clinical trials involving 5 and 10 patients, a 
> moderate beneficial effect was shown. However, when a large controlled 
> clinical trial was later carried out by the same people, GDNF had no 
> effect at all in ridding Parkinson's Disease.
>
> Rayilyn Brown
> Director AZNPF
> Arizona Chapter National Parkinson Foundation
> [log in to unmask]
> ----------------------------------------------------------------------
> To sign-off Parkinsn send a message to: 
> mailto:[log in to unmask]
> In the body of the message put: signoff parkinsn 

----------------------------------------------------------------------
To sign-off Parkinsn send a message to: mailto:[log in to unmask]
In the body of the message put: signoff parkinsn


----------------------------------------------------------------------
To sign-off Parkinsn send a message to: mailto:[log in to unmask]
In the body of the message put: signoff parkinsn