Georgetown Receives FDA Clearance for Trial with Nilotinib in Alzheim
 

It's for Alzheimer's but may be an early look at Parkinson's

Georgetown Receives FDA Clearance to Conduct Clinical Trial with Nilotinib in Alzheimer’s Disease | Georgetown University Medical Center | Georgetown University

Zanpar, you're right that this might give some insight into PD. However, I found it quite disappointing when I saw the story the other day. It's sad that no organization would fund them for a PD trial, given that was their primary research. It sets us back that much longer.

On the good news front, the MJFF/Cure Parkinson's Trust trial will be proceeding, although it won't be until sometime next year. I was with Tom Issacs, the founder of CPT last week and with some of the MJFF research team today. They were all quite confident and positive about the study going forward. Furthermore, while GU's study will be a smaller, one site trial, MJFF intends to have a larger, multi-site study. This will make recruitment easier, and allow a better opportunity for those of us interested to volunteer and participate.

Gary

Great Gary, Thanks for the news on the trials.

Question regarding funding of GU's Nilotinib PD trial
 

Tupelo3 said: "no organization would fund them for a PD trial"

I didn't see this information in the article linked to by zanpar321. Do you have a link or a reference that you could share with us?

You can google multiple stories over the past year on their difficulties in attaining funding, culminating in the split with MJFF/CPT. If they had PD funding then you would seen an IND announced for use in the larger phase 2. I know of their difficulties from multiple sources in the PD community.

They were able to find funding with the ADDF, as stated in the release. They will study 42 AZ patients. Half will get escalating doses of Nilotinib, half will get a placebo. The study primary outcomes will test safety and dosing. Cognitive and functional testing will be secondary tests along with several AZ biomarkers, although, drug efficacy is not the primary outcome .

I am told that the GT team would still like to do a PD trial. Sorry, that's all the info I have at this time.

Just wondering why Novartis (maker of Nilotinib) wouldn't offer funding to Georgetown team to get this study underway? It seems like a no brainer to me to fund their own product or do they know something we don't know?

As a follow-up to the previous posts, I was told today that GU is still making every attempt to move forward with PD trial simultaneously with the AZ trial. Need to secure the $.

Gary, do you know why Novartis doesn't fund the PD study?

I'm not exactly sure but suspect it has something to do with the break up in negotiations with MJFF/CPT/VARI on the larger combined trial. GU has stated that they are still trying to get Novartis to donate the drug.

Update on GU's plans next month (maybe)
 

Regarding GU's plans for a Nilotinib PD trial, Betsy859 will (hopefully) be able to give us an update next month.

http://www.neurotalk.org/parkinson-s...b-trial-4.html