these people have been around for awhile and have worked with gdnf - obviously still believe in it. Gill, from the UK, was an investigator in the phase II halt, didn't agree with the halt but stayed out of it and focused on better delivery.

http://www.genengnews.com/news/bnite...?name=72730472

try this one: http://www.pdonlineresearch.org/news...apy-parkinsons

Jan 12 2010, 3:00 AM EST

MedGenesis Announces Agreements With Amgen and Biovail

MARKETWIRE

Jan 12, 2010VICTORIA, BRITISH COLUMBIAMARKETWIRE

MedGenesis Therapeutix Inc. ("MedGenesis"), a biopharmaceutical company developing and commercializing innovative treatments for patients with serious central nervous system (CNS) diseases, announced today that it has successfully entered into an agreement with Amgen Inc. (NASDAQ: AMGN) ("Amgen"), granting MedGenesis an exclusive, worldwide license for glial cell line-derived neurotrophic factor (GDNF) protein in CNS and non-CNS indications, subject to the rights of a co-exclusive licensee for CNS indications in certain countries....

MedGenesis has also granted Biovail a license to its Convection Enhanced Delivery (CED) platform for use with GDNF in CNS indications. MedGenesis and Biovail will initially focus on the development of GDNF for Parkinson's disease, a progressive and debilitating neurological disease affecting close to 5 million patients worldwide.


paula

just have to try and forget the "wasted" years.

Neil.

Yes Neil, and you put that about as positively as possible. Moving along, here's hoping it will be a short decade and then straight to market.

paula

Honestly, I don't know whether to cheer or cry over this news. Amgen halted all human trials of GDNF in September 2004.... Amgen sat on their patent for GDNF for over 5 years. Here's hoping that MedGenesis and Biovail will move the research forward quickly and successfully through clinical trials, and wil realize that patients can be valuable research partners if given the chance.
All i can add to Paula's posting is "AMEN"

(Buzz from a blog titled:" biopharmaceutical Industry intelligence and analysis blog" Note the info concerning new delivery system utilizing a "pressurized infustion to deliver drugs to the brain")

http://invivoblog.blogspot.com/2010/...-to-stars.html

--"Amgen/Biovail/MedGenesis: Since its annus horribilis... 2007, Amgen has been more willing to share.. the once-voracious acquirer is now... an out-licenser, and this week it sent exclusive global rights to glial cell line-derived neurotrophic factor (GDNF) ...to Canadian firms MedGenesis Therapeutix and Biovail. Terms weren't disclosed other than Amgen taking what the firms described as a "small equity stake" in MedGenesis. Near-term, the three-sided deal allows Biovail and MedGenesis to team up and develop GDNF for Parkinson's disease using MedGenesis delivery technology. MedGenesis said it also has taken rights to GDNF for non-CNS indications and could collaborate with other partners. The Vancouver firm is applying its platform of convection enhanced delivery, which uses pressurized infusion to deliver drugs locally to the brain, to treat epilepsy and glioblastoma multiforme. -- Alex Lash"

Could it be Amgen is willing to "share" license to GDNF because MedGenesis or Biovail have developed a new delivery system, thus letting Amgen off the hook? Should the new clinical trials prove positive, Amgen can claim "oh look, the new delivery system made all the difference.."

Madelyn,

and, like it or not, that's the best we can hope for. It was the delivery system, along with many other factors that went wrong in that trial. But they took it away from everyone and lied about many things. They were never that concerned about the antibodies or even lawsuits. The catheters shifted but there were no side effects.

What would it take to get them to begin at phase II? Where would we begin?

Adding additional questions:

Are these the same people who said gdnf would only work on early stages of disease?

Are they going to hold trials in the U.S.?

paula

this is a rehash of the Amgen lawsuit, with bullet points and brief explanation of why the suit was lost. Pages 17-25 deal with the Amgen lawsuit

http://legal.ucsf.edu/hrpp.ppt#259,1,Human Research Protection Programs

(FYI--the Oliveri suit preceeding the Amgen one is fascinating in a reprehensible way. )