Prosavin


#1
I, like many others, was thrilled to see and hear news of the extremely promising trial results of prosavin gene therapy carried out in Paris and Cambridge 12 months ago.
I was stunned to hear from the research leader at Addenbrookes hospital that it has proved impossible to raise funding for the next stage of clinical trials and research has therefore come to a halt.
Am I alone in seeing the hand of greedy and amoral drug companies somewhere in this?
Cannot the PDUK coffers offer aid?
To my untrained eye this has seemed the most promising development in years.
GG

#2
seconded!!!!!!!

#3
Perhaps Research could clarify the situation for us?
Thanks
GG

#4
This is the same as with the GM1 ganglioside. GM1 ganglioside, even if not neuroprotective, it has strong symptomatic benefit. It could delay the need for levedopa and at the same time delay diskynesia due to long levedopa usage. However, many mysterious reasons that really don't convince me are used to explain why not use it.

With prosavin ? Probably similar non-convincing arguments will be given.

#5
Hello everyone

Thanks for highlighting this issue with ProSavin to us goldengirl -obviously we're keen to see this research move forward too.

Kieran (our Director of Research and Innovation)is away at an International Conference this week but he's aware of the situation and will investigate further when he gets back.

Best wishes

Claire
Research team

#6
Hello everyone

Apologies for the delay in getting back to you. We have been in touch with a researcher carrying out part of this study. The long term follow-up study is proceeding as planned. They are developing a second generation 'ProSavin' with an expected improvement in efficacy and they are aiming for this to start clinical development in 2014.

Read more about the 'ProSavin' trial in the Oxford Biomedica press release - http://bit.ly/119dBTL

Unfortunately we don’t know as yet the exact dates for the next trial or where it will be based but we are keeping a close eye on any developments and will share any news through our website and magazines.

All the best,

The research team

#7
The link is the news published 13 months ago. At that time the improved version was under development.
Presumably the only monitoring is of those patients already treated.
The information from Addenbrookes at that time was that phase 3 trials would begin at the end of 2012. It is this development that has not attracted funding and is not in the pipeline.
Am I to understand that no new trials are planned until 2014?
Thanks
GG

#8
Hi goldengirl

The people who have already been treated are currently being monitored and the new drug being developed. We have been told that recruitment will indeed begin in 2014.

The delay is due to clinical rather than financial reasons.

We will of course keep you updated when we know more.

Best wishes,

The research team

#9

Have there been any further details released on the next phase of trials.  This seems to be in need of consideration if thinking of being part of the GDNF trial.  


#10

http://clinicaltrials.gov/show/NCT01856439

I find this hard to understand but I assume it means that patients who had the 1 injection treatment are being followed up in France only and will be monitored until 2022.

Considering all the publicity about the amazing results a couple of years ago it seems incredible that this is the only development .

I was told by a leading researcher that funding was no longer available in the UK for further work on this.

If 1 injection all but cures Parkinsons and minimises the symptoms and slows the progression, there will be a huge loss of income for the drug companies and the need for the Parkinson's Disease Society.

Am I alone in seeing a link?

GG


#11

Certainly a 'one off' or 'single point' infusion/injection into the target area does seem to be a more scaleable approach compared to the 4 implanted tubes and skull port for the infusions as per the GDNF Trial.  One question that jumps out at me is with the GDNF tubes in place if that trial's magic infusion does not prove effective enough to roll out, could ProSavin be delivered via that delivery system.  If the GDNF trial evidences a successful delivery system then could it be used for other solutions.

I think the drug companies patent lifespan on existing drugs is the key to how readily they look to develop neuro factor solutions.  


#12

Could research check what is happening in the Prosavin research and also answer Kendo's point?

Thanks GG


#13
Hi goldengirl
 
The latest results from the ProSavin trial were published in the medical journal, The Lancet,  last week. We commented on the findings on our website: http://bit.ly/1iXRP2b
 
We don’t have any new information on the next phase at the moment. But we will highlight any future developments through our website and magazines. 
 
To answer Kendo’s question, the system being used in the current GDNF trial was designed specifically to deliver regular infusions to the target area of the brain. This is an entirely different approach to that being used in the ProSavin trial, so it’s unlikely to be suitable for this application.
 
Best wishes
 
Katie
Research team
 

#14

http://clinicaltrials.gov/show/NCT01856439

Thank you for your reply.

However you do not comment on the link I gave you which makes it clear that the further research only consists of monitoring the patients in France who have already received the drug , until 2022 to see if they continue to improve and still experience no adverse side effects.

There are no plans to offer the therapy to any more patients.

Can the explanation be that it will allow the drug companies the maximum time to profit from products still under patent before Parkinson's is treated with a once-only injection and their drugs are not needed?

GG


#15
Hi again goldengirl
 
As far as I’m aware, Oxford BioMedica (the company developing ProSavin), have no connection with any existing Parkinson’s medications. So a delay really wouldn’t be in their interest.
 
According to their paper in The Lancet, the researchers are currently trying to improve the delivery method and work out the best dose for ProSavin. They plan to carry out a more definitive double-blind placebo controlled trial once they have done this.
 
I hope this answers your question.
 
Best wishes
 
Katie
Research team

#16

Thank you for your speedy response.

I can find no mention of new trials in the Lancet report but forum readers can only read a limited account without subscribing.

Perhaps you could expand on the content and be more specific about the future enrolment of New Guinea pigs in the UK?

I understood that the Lancet article was responding to the link I gave of the  clinical trial results published in May 2013 and made public in January 2014.

GG


#17

http://www.youtube.com/watch?v=bK9M2uHt5gk&list=PL6EA9589611C753C9&index=1

the sheep is hilarious and the horse makes a comment at just the right time.

i dont think this technique can be used for gdnf - this is virus that caries genes whereas, i think, the gdnf trial is adding a protein . 2022 is a long way off, but then changing neurons' roles using genes does seem quite risky so they need to be very careful.

by the look of it prosavin is not a cure but potentially a useful additional  treatment for mid to advanced pd. it would be, i think, be limited to movement problems, which are obviously important but not everything in pd eg wouldnt affect dementia.

http://www.oxfordbiomedica.co.uk/prosavin-r/

 


#18

It is worth pointing out that, apart from Rasagiline (Azilect) the other mainstream PD drugs are off patent. So that would imply that now's the time for a drug company to bring forward something new, on patent, and more expensive if they had it.

Now, whether there are enough PWP in the developed world to make major investments in researching new drugs, that's another question. But I can't see any drug company holding back for patents to run out.

I fear the truth is more along the lines that PD is really complicated, we know a lot more about it than we did a few years ago. But still we don't know enough about the mechanism behind the neuron decay and death for a breakthrough to be certain. Sooner or later some researcher and/or drug company will strike lucky - I just hope its sooner.


#19

Hi goldengirl

Unfortunately, the full article is behind a pay wall. You may be interested in the press release, which covers the main points.

But the focus is on the current findings, rather than future plans. So there isn’t really much more detail.

We’ll be keeping an eye on developments, and will highlight any opportunities for people with Parkinson’s to take part in future trials as and when they arise.

Best wishes

Katie

Research team


#20

There's an update by the ever-reliable Mister X at http://www.parkinsons.org.uk/forum/thread/58299

Not good news

S