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Aimspro clinical trials- status?
Posted: Mon Nov 08, 2004 12:02 pm
From what I understand the Aimspro clinical trials have been going on for over a year. If this medication is as effective as the anecdotal reports seem to indicate, I would think that they would stop the trials early...?
Does anyone have any information on this?
On one hand it is fairly standard to have a early endpoint if it is overwhelmingly (statistically) obvious that the treatment is helping.
Then again, doing this with an unconventional medication which is going for fast-track approval and hasn't gone through animal testing and the like...may be seen as a bad idea. They may want solid "proof" that this stuff works!
Does anyone have any information on the status of the trials?
Posted: Mon Nov 08, 2004 1:21 pm
I asked, two months ago, if they could supply it privately and this is the reply I received from Daval International:-
"We are unable to supply our drug, Aimspro for treatment until we have
received a licence to do so by the Medial Authorities. Aimspro is currently
under clinical trial, the results of which will assist in our application
for a licence in due course.
Please continue to follow our progress at www.davalinternational.com
I checked again just now and there is no change just yet......
Posted: Mon Nov 08, 2004 2:44 pm
Check out sites www.proventus.org.uk
for more information.
Sign the petition to help the Aimspro Lobby.
Posted: Thu Nov 11, 2004 3:51 pm
Optic neuritis trial has been completed and we can exspect clinical data some time in November.
Posted: Thu Nov 11, 2004 5:19 pm
Hi Janey... thanks for sharing the information -- are you in the trial?
Posted: Fri Nov 12, 2004 4:26 am
I've put some very unenthusiastic posts recently but I though I should add this too, sorry
Hearsay only of course but a quote from the neurologist treating me a reasonably open-minded chap (OK'd antibio tretament for me):
"Don't ask me for goat serum! It's bad
science, almost unethical!"
He's not impressed! Look forward to the CT results.
Posted: Sun Nov 14, 2004 8:59 am
I would suggest you ask him the next time you see him just how much he knows about it. Then ask whether he thinks the calibre of scientists and doctors involved are those who would typically be involved in "bad science".
He sounds rather ignorant of what's involved and is voicing it in such a way as to make himself sound cleverer than he really is. It's so easy to rubbish something you know nothing about - only when such ignorance is directly challenged is this kind of error seen for what it really is.... pomposity!!
Check out www.proventus.org.uk
for more info, but don't be too disappointed by the lack of hard data - it's in the pipeline and due soon.
Posted: Mon Nov 15, 2004 2:15 am
I think I'll wait for the clinical trial results, Mark, before raising the topic with my neuro. Certainly from the press reports here in the UK and stuff one reads on the web the anecdotal eveidence for a positive response seems strong in some cases. But isnt that always it - in some cases ! We should remember that reporting bias will always kick in - in my experience people dont report bad news like "That drug didnt work for me!"
Good luck to anyone on the trial, I look forward to a really statistically significant outcome that will allow me to say to my neuro "If I take Aimspro we'll be 95% confident that the quality of my life will improve." But I'll need some good data for that!
Posted: Tue Nov 16, 2004 6:27 pm
I have no problem with anyone wanting to wait for hard evidence or clinical trial results - it's a perfectly sensible approach. One major reason Proventus was formed was that a comparatively tiny company like Daval could face HUGE opposition from other industry players. We felt that the best way for us to help protect Aimspro and it's continued development was by raising the profile and general (and political) awareness about this treatment. We would never have stood an earthly chance of raising a substantial fighting fund - ie. millions! - so People Power has been our chosen route.
I don't believe that either Proventus or Daval has even remotely misrepresented the facts or tried to boost hopes unfairly but given what I - and many other informed consent patients - know to be true it is enormously difficult for us to give an opinion that doesn't seem wholeheartedly behind this treatment. We know the results and we can't wait for the rest of you to find out too... but that doesn't dull our concerns over "competitors interests" and a desire to protect.... Even if it means us harping on about it on discussion boards and jumping on any ignorant or hostile postings. We are lobbying for Governmental oversight (against "interference") and general awareness both in the public and the medical domains - we are most definitely NOT advocating any short-circuiting of normal licensing processes or getting it "rushed through".
It's kept me from a very grim future!!! And I'm naturally very passionate about that!
Posted: Tue Nov 16, 2004 6:31 pm
PS. Janey and I both use the same logon... I'm a patient from the "guinea pig (ie. pre-trials) days nearly four years ago. Janey's my partner.
Posted: Wed Nov 17, 2004 9:51 am
I had look again at the Daval and Proventus sites but couldnt find much in the way of "science" - good or bad
OK there's empiricism, lots about clinical trails, case histories and that kind of thing but no more basic science references other than: "Aimspro uses polyclonal antibodies from the serum (the fluid portion of blood) of goats."
Is there something on PubMed or somewhere I can look that tells me why injecting this PAB might be good for me? And why better than the current flavour-of-the-month MABs. Someone must have done some theoretical work I'm sure. Now, its very unlikely that I'll understand much (indeed any) of what is written
but I'd like to know their approach.
Posted: Wed Nov 17, 2004 2:46 pm
I'm sorry there's not a lot of "hard science" on our site... a/ it's not intended as a technological site, just as an informative one for Joe Public & MS people more than anyone else; b/ that Daval do not share their scientific information with anyone until the time is right and it's safe to do so. Maybe there's an element of paranoia in that, but I can't really blame them given the power of those who would prefer that they fail in taking Aimspro through to licensing.
The first trial data is due out soon and hopefully that will assuage some thirst for knowledge. For a while anyway!
Essentially they will let more info out as seems appropriate. But their priority will be to make progress toward licensing before
they worry about satisfying enquiries from patients or interested individuals. I'd love to know more too myself, but I won't waste their time or distract them from more important work (my view, not necessarily theirs).
Best regards, Mark