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MS trials

Posted: Sat Oct 22, 2005 8:47 am
by bromley
There must be more MS trials on-going than there are sufferers. Here is a list for all of you in the US. Annoyingly, many are trials of the CRAB treatments - which we all know have limited efficacy. It doesn't matter how many trials they hold on these drugs - the performance will remain moderate at best. I suppose the manufacturers are using their financial muscle to entice more users.

The only new-comers I can see are Dacluzimab and statins for CIS.


http://c.moreover.com/click/here.pl?j410189329&w=464753

Re: MS trials

Posted: Sat Oct 22, 2005 3:06 pm
by dignan
You said, "There must be more MS trials on-going than there are sufferers." I agree it seems that way. In my more cynical moments I actually think that the CRAB manufacturers/marketers are deliberately doing extensive ongoing testing of the CRABs just to tie up eligible trial participants to make the life of their competitors that much more difficult. It won't make other drugs impossible to test, but it makes it more difficult and time-consuming. A one year delay in a potential competitor's clinical program is worth a lot of money in additional sales to a CRAB maker. My conspiracy theory for the weekend. Next week: how JFK's second gunman caused MS...stay tuned...

Posted: Sun Oct 23, 2005 3:27 am
by bromley
Dignan,

I think you are spot on. There was an advert in the London Evening Standard some months ago for a trial of the MS drug being developed by Abbot. I rang the hospital and they sent me the forms and they booked me an appointment. They phoned up a few days before and cancelled - I suspect they had trouble recruiting. In reality if one is diagnosed with RR MS the neuro offers you one of the four CRAB drugs. Once you start injecting you'll be unlikely to want to go on a trial where you could be given a placebo. I posted something a few weeks ago which said that the current CRAB drugs bring their manufacturers $4 billion a year which should rise to $5 billion by 2010.

Some observations.

- It's now 18 months since the Calgary team reported good results from a small trial with minocycline, but it's all gone quiet - except that the trial is going ahead as copaxone + minocycline. If minocycline had been shown in a larger trial to be as effective as the CRABS then the big players would be waving goodbye to huge revenues. How good of Teva to step in. I note that Avonex is being trialled with doxycycline. I bet both companies will tell us how beneficial the combo is. I also bet that the trial is not done on the basis of Copaxone alone; Copaxone and minocylcine; minocycline alone.

- If Tysabri gets reapproved, it will be interesting to see what Serono, Teva etc will do. I'm sure the latter will keep reminding their customers of PML.

- The Phase II trial of Tovaxin looks promising (92% reduction in relapse and EDSS reductions) but some of these smaller companies have real problems funding the required trials. I wouldn't be surprised if the company got bought by one of the biggies.

- I'm pleased to see that the UK MS Society is starting to fund some trials eg Lamitrigne (sp?) which is a two year trial for those with SP to see if the drug can slow atrophy. The UK's medical reaserch agency is also funding trials of cannaboids to see if they have an effect at stopping the progression in SP sufferers.

Your list of potential drug therapies looks impressive, but I fear that many will fall by the way side due to the costs of funding a trial or getting the required number of participants.

The company which I think has some interesting neuro-protective therapies - Neuren - is a small company but has teamed up with the US Army to part fund its trials (as neuro-protection is beneficial in trauma as well as neuro-degenerative diseases).

2008 look a possible date when some more therapies come on stream - oral treatments in particular. But the CRAB manufacturers are busy buying up some of these treatments e.g. Dacluzimab to make sure they do not loose out.

The other company I follow is Acorda Therapeutics who have some interesting early stage drugs aimed at regaining lost functions. However, for most of their therapies they state that they are looking for partners to take them forward.

It's difficult to see what can be done to improve things when the CRAB manufacturers are content with the revenues they are getting from their current portfolio of drugs. One option would be for the National MS Societies to get together and fund some trials of promising drugs. I know this can be expensive but the NMSS has spent $500 million since the mid 40s on MS research with little real return. National Governments might also have a role given that MS costs them billions each year - treatments, disability pay etc.

At last year's UK MS Society research conference one of the key speakers said that a three stage approach is needed to combat MS (i) stop attacks, (ii) protect nerves / axons, (iii) regenerate the nerves / axons that have been damaged or destroyed. To date the big drugs companies have only really focussed on the first - and are offering drugs which are moderate at best. We now know that it is the degeneration of axons that causes permanent disability and that relapses may only have a moderate effect on the progress of this disease. If the drugs companies do not want to get their hands dirty with regard to (ii) and (iii) then the MS societies / government need to step in.

Bromley

Posted: Sun Oct 23, 2005 10:18 am
by Rita
The problem is that MS associations have people from the manufacturers inside the organization trying to pressure them to put the money in his products; they have a very convincing guys or convincing methods, don’t really know. You just can see the amount of money they waste in CRAB’s instead of new products, and if they do not, who is going to do that? To do clinical trials is excessively expensive. Maybe if all the people from all (at least) the European Union demand better ways to spend OUR money they think about EM, considering that is a very expensive disease for all governments.

Rita

Posted: Sun Oct 23, 2005 2:47 pm
by dignan
I agree with both of you that government and/or NGOs like the MS societies should step up funding of clinical trials if possible. I do think that pharmaceutical companies, yes, even the CRAB makers, are trying hard to come up with new treatments. Many of these companies are publicly traded and are seeking to maximize shareholder value through having a full pipeline. If nothing ever comes out of your pipeline, the investment community will lose faith in you and your stock price will plummet.

Where the whole medical/pharmaceutical community doesn't seem to have done such a good job is in investigating existing older drugs that are used for other purposes. No patent, no profit, no interest. This has been mentioned by many people at ThisisMS before, but it seems relevant in this thread.