Article from the Times Colonist, Victoria, Canada, 7/24/10

"Local biotech firm believes it's on the cusp of a brain breakthrough"

is about MedGenesis, the Canadian biotech that managed to get the license from Amgen, after 4 years to further develop GDNF. They are using a convection enhanced delivery system, that allows the delivery of GDNF through microscopic catheters to highly specific targeted areas of the brain.

. The company seems to be committed for GDNF to succeed,.(very un-Amgen like ), although there was possibly worrisome statement in the article :
"In reaching the licensing deal with Amgen, the American company now has a small equity stake in MedGenesis “

Not sure what that means for the future but for now we are happy that new clinical trials are being planned, using a number of delivery methods.


Excerpts:

"According to MedGenesis CFO Michael Lincoln, the company is estimating the
cost of getting GDNF through the trials and to market could be anywhere between $65 million and $100 million."Financing is always a key issue, and it was to our bad luck that the bottom fell out of the world economy at the time we needed to finance operations," said Mohr (CEO), who noted the company has managed through it because he had significant personal resources to draw on and a number of well-heeled contacts who bought into their plans.

Mohr also pointed out his executive team stuck with the program. He took no salary for three years and his team worked for cut rates.
Mohr said the fact his team remains intact is testament to the belief in what they are doing.
"Our entire executive team is still at the table, nobody left," he said.
"There is something there."

"Mohr is hopeful they can begin Phase 2 clinical trials next year, a process
expected to take about two years, including data analysis and dealing with Health Canada and the federal Food and Drug Administration in the U.S.
"We're going to manufacture the product and go back into the clinic next year and
we're very hopeful a pathway to success can be found," he said.”

Read full article at

http://www.timescolonist.com/health/...#ixzz0udpxbHyO

it's phase I or nothing for me. i don't have time for sham. wish they would move faster.... we are the lost generation and perfect for researching how well it works with advanced. we know all about it , we'd be more objective than they would about our progress/ we need informed shams who would be very aware they might have a placebo.

but why shams at all? are researchers really looking for a treatment?

they already did gdnf with shams but we spent all our time talking about the leaky delivery and harmless antibodies. Did anyone look for patterns among those who it helped and who it didn't? it worked for advanced patients too. i fear that answer is no -They must plan on it makiing money or Amgen woulldn't do it Let's just do it- who are the champions of ths trial? who is pushing for us this time l- last time he died of a heart attack and was replaced by seniority not true hope in gdnf. Hate to spoil the party but they have been working on this for several years.

How about recruiting now / be ready to go ?? surely there are ways to accelerate this trial, which for some of us is our only chance.

i'm not boo hooing; i expect people to be competent and recognize the need to proceed, I don't know if I have any gene mutations because my spit is lacking DNA...GEEZ so just give me the brain fertilizer.

THANKS LINDA

..."He took no salary for three years and his team worked for cut rates...."

Now I've seen everything.

Sent: Sunday, July 25, 2010 3:03 PM
To: James Hatton
Subject: [James Hatton on licensing] New comment on MedGenesis Announces GDNF Licenses and Collaborati....

Bob Dawson has left a new comment on your post "MedGenesis Announces GDNF Licenses and Collaborati...":

There is a new discussion over at Neurotalk about MedGenesis and GDNF - your creation, in a sense! It would be great if anyone - yourself or someone at MedGenesis - could send off some solid bits of info from time to time, to all us PWP over here at Neurotalk. Nobody tells us straight on, hardly ever. And what was thing about the exec. guy taking no salary for 3 years. Are they kidding me? Did time and space invert and run backwards or something? Is that for real?

Thanks for the comment, Bob. I will pass it on

Much as I hate sham surgery, if I'm eligible for the MedGenesis phase 2 GDNF study (and if there is a study site as near as California), I plan to sign up.

jean

I have written to MedGenesis and also to one of their scientific advisors at UCSF. I'll let you know what (if) I hear from them.

Jean

Oh well, we can't all be rats or guinea pigs.........

I guess this one will take it's time as well to get to the many who need it. Look at duodopa and pet scans, all dawdling away time......

It would be nice if this was the one for at least some of the multitudes.

Since so many on this board have campaigned for gdnf for so long, i would be surprised if I didn't see some senior members showing an interest in participating in this trial.

jean

I can't imagine they will have any problems recruiting participants for this and other GDNF trials. We should also make the sponsor and trial doctors aware that a large part of the parkinson's community will be watching closely this time around.
linda

Read just now that they were doing this with patients in the UK in 2012, I think it is the same but lost the link........ maybe someone else will know, don't seem to be able to get back to it......