This Is MS Multiple Sclerosis Community: Knowledge & Support

I just had a look at the Daval International site and to my horror found this:-

Daval halts trial over hospital protocol concerns.

Does anyone know more details?

Dear all,

The statement from Daval's website is as follows:

Daval halts trial over hospital protocol concerns.
A statement from Daval International: 2.3.05

With the completion of one successful trial at the Radcliffe Hospital Oxford, Daval International brought the trial for secondary progressive multiple sclerosis at St George’s Hospital in London to a halt because of concerns regarding hospital implementation of agreed product handling protocols.

On Tuesday 1st March 2005 Daval International’s lawyers wrote to St George’s Hospital instructing St George’s to bring the trial to an immediate halt. This was as a result of frequent breaches of the agreed protocol for conducting the trial on the part of the Hospital.

Daval International have advised St George’s Hospital that their multiple sclerosis patients affected by this decision should contact Daval International to discuss their continuing access to Aimspro.

The decision by Daval International to halt the trial was taken with regret and only after extensive consultation. The other treatment programmes being undertaken by the company are unaffected.



No more detail. What a good week this is turning out to be - first Tysabri and now Aimspro. The great hopes have faded away. But that's MS for you.

Bromley

Apologies - didn't see the Aimspro posting on the front page

There are some people in the trials who have posted here.

Information, please!

It has to leak out....why not leak it here first?

Yes, Aimspro trialers - if you know what’s really happened, please tell.

To someone dependent on the UK health service the reason Daval gives seems a bit weak . We all know that UK hospitals can’t even maintain good hygiene protocols so surely Daval should have been prepared for procedural failures - why on earth didn’t they build in they own safeguards?

I am confused about the Aimspro trial which I thought had finished late last year. The UK MS Society websites says that:

A controlled trial (where half of the participants are receiving the treatment and half are on placebo (a dummy treatment) is ongoing at St George's Hospital in South London - this should provide us with the research evidence that is currently lacking. 80 participants are involved, all have Secondary Progressive MS. Recruitment for this trial has stopped - no more referrals can be made to this trial. No results are expected from this trial until June 2005.


Just a guess but perhaps those on Aimspro showed no significant difference compared to those on the placebo. Daval's reasons for stopping the trial seem pretty weak.

Bromley.

I don't know how their reasons would seem "weak" when they haven't told us why they stopped the trial, yet.

I hope more information is revealed, soon.

They say the trial was stopped as a result of frequent breaches of the agreed protocol for conducting the trial on the part of the St George’s Hospital. That seems pretty weak to me and I wish we could discover exactly what sort of breach would necessitate the end of such important trials.

However, when I spoke last summer with someone at the Radcliffe who had close contact with many of the patients on the first trial, she warned me not to be too optimistic about goat's serum because she had not seen anyone in the group improve at all. I asked what she meant by 'group' and she told me it was everyone, those on the drug and those on the placebo. As part of the admin staff she did not know one from the other.

So perhaps Bromley’s theory is correct? I'm still terribly disappointed at yet another UK hospital being unable to follow rules to which they have previously agreed.

There are a few references to UK hospitals breaching protocols in the past... what is this in reference to?

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Disclaimer: Any information you find on this site should not be considered medical advice. All decisions should be made with the consent of your doctor, otherwise you are at your own risk.

I would have thought that they would have been more or less 'compelled' to go through with the trial if at all scientifically possible. Hence the public explanation seems plausible. I'm not sure that the 'poor results' theory holds. If the results were not coming out as they would ideally like, would they not be more likely to do what seems the norm with MS statistical studies. Ie. they might bend the figures to suit or 'gild the lily' as they say......or am I being too cynical about the world of science where mega-bucks/pounds are involved?

Dear all,

The Daval website says that:

The first trial began in the summer of 2003 at the Atkinson Morley Wing of St Georges hospital in London and will run for 18 months.


So the trial should have been over by the end of Dec 04. And one would assume that initial results, say based on one year, would have been available.

It really looks as if the trial results were less than impressive and the company is looking for a scape goat (excuse the pun). The initial publicity talked about people getting out of wheelchairs, seeing again etc. But this was not under trial conditions. It looks as if this will be another treatment that fails to deliver against the initial claims when properly tested.

It's up to Daval or the trial managers to provide us with more information than the protocol reason. I could be wrong but MS has a nasty way of winning at the end of the day.

To quote from someone else - hope for the best but prepare for the worse.

Bromley

I have seen an explanation posted on another board that Aimspro must be kept frozen until just before delivery. The assumption there is that the hospital was not keeping the drug frozen or was defrosting it too early.

For myself I'm skeptical. Aimspro is a polyclonal antibody. None of the other antibody treatments i.e. Tysabri needs to be kept frozen, why should Aimspro be different.

I'm with Bromley, the results didn't stand up so they canned the trial. All information I have seen on Aimspro says that it is a powerful anti-inflammatory with steroid sparing properties. The trial was on SP patients. Once the disease has passed to the SP phase it is generally accepted that inflammation is no longer the primary cause and that steroids have minimal effect.

Frankly the whole Aimspro saga disturbs me. There has been much hype and publicity but no scientific evidence or explanation. There has been minimal trialing, yet people are clamouring for this treatment.

We have just seen what another antibody (Tysabri) can do. I wouldn't touch Aimspro with a 10 foot pole without a lot more evidence and explanation.

Robin

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Do not go gentle into that good night. Rage, rage against the dying of the light.

If Aimspro does not work, this will become clear soon enough.

But the company has nothing to gain by lying about the reason that the trial was canceled- they can't get a license for it anyway, if it can't be demonstrated that it works in a randomized controlled trial.

We can speculate all we want, but it is all just speculation until we have more facts. And, at this point, it's fully possible that Daval did the right thing by canceling the trial, because the hospital was breaching the protocol in some way.

Let's see if the truth leaks out soon!

I don't have any interesting information, it just seems to me that when treatments don't do well in trials and the trial is not even completed, the drug company kills the trial quietly, they don't put out a press release about it.

the trial should be completed though, whether or not they're having good results. That's the point of the trial. The only extenuating circumstances that SHOULD be in effect are if the drug is actually causing harm versus placebo, in which case the ethical move is to stop administering the drug.

I believe Daval would have had to come clean on that and not have found an excuse-- otherwise every major drug company could get out of failures by inventing protocol aberrations. This does not happen very often, at least with publicly traded companies. See Axonyx and Pharmos Corp for two recent examples of spectacular drug failures that were openly announced.

One other thing to note is that it seems (anecdotally) that Daval's first round of patients were also recruited as investors... well Daval will certainly have to tell their investors why this trial failed and those investors, now significantly less wealthy, will have the story to tell.

_________________
Disclaimer: Any information you find on this site should not be considered medical advice. All decisions should be made with the consent of your doctor, otherwise you are at your own risk.

Hi Aaron,

If a trial is not being conducted properly by the independent researchers then the manufacturer has EVERY reason to can it. To have to continue and quite possibly end up with unrealistically poor end results seems quite ludicrous to me. Where's the scientific benefit or logic in that? Would it be acceptable to have a flaw in the research that led to unrealistically GOOD results? I think not.

I've been on it for 4 years, know a lot of other informed consent patients and know of NO side-effects other than some temporary redness and swelling at the injection site.

Daval's private company status has nothing to do with secrecy and everything to do with keeping their project out of the hands of unscrupulous "big money". As for recruiting from their early patients... if I had had the wherewithall to invest I absolutely would have done so, for reasons of both gratitude and wanting to help this company which had done so much to change our lives (at no cost to us either) and out of sound financial sense. Sure a substantial number of small investments have come from patients but you are totally wrong to suggest that the company had any kind of recruitment approach within this group. Most of us weren't working or able to consider affording it. The great majority of investment has come from non-patients.

It's interesting to see this "anecdotal" comment in the light of previous criticism of Daval for having "anecdotal" evidence...

Regards, Mark