This Is MS Multiple Sclerosis Community: Knowledge & Support

Dear all,

I think this is a debate that can run and run and will only be concluded once the relevant authority grants or does not grant approval for this treatment. This decision will have to be made on the basis of completed trials and the success or otherwise of them. If the treatment does turn out to be as good as the press reports, one could imagine one of the larger drugs companies making a bid for Daval or purchasing the rights to Aimspro.

I would like to find out more about Daval International and in particular who is financing Aimspro. I understood that small investors had provided the finance - probably on the basis of the press reports.

Let us all hope that Aimspro is as effective as we have been led to believe.

Bromley

Dear Bromley,

The question of the granting of a license becomes academic if Daval has been bled to death in the interim. An un-named complainant raised an undisclosed complaint against Daval last year to the DTI who, in the process of their investigations, found nothing untoward other than some comparatively minor discrepancies in operating procedure which they advised the company to change. No charges were brought, no action was taken but Daval had to spend precious resources fighting their corner and lost the opportunity to raise further investment (their only current source of income) during this 3 month period. An ongoing campaign of obstruction and legal sniping is exactly the kind of action that makes sense if you want to kill off a small company, or their product.

All investor information is in the public domain at the companies House website. Investors, both large and small, were the source of operating revenue after David Shotton had almost single-handedly funded the company from day 1. Some patients have indeed bought shares - they may do very well in the end from it - but I would wager the large majority had an equally strong committment to helping the company which had effectively done so much for them - and at no charge!

I would also like to point out in answer to questions raised on other discussion sites - that at no time have Daval either deliberatly sought investment from these informed consent patients not have they ever even alluded to the idea that investment could possibly bring about a place on this list. Apart from having been a patient for 4 years, I have personally attended 90% of the company's investment meetings so I should know.

I know I keep harping on about it but I will repeat my motivation for defending/supporting Daval/Aimspro... this is an extraordinary treatment that deserves to be given nothing less than a very fair shot and only judged on its results. Industrial "warfare", political manouevring and bureaucratic dithering do not have a place in this process, yet they exist. They have the potential to delay or even destroy Aimspro and it is therefore quite understandable and certainly morally correct for some of us to be prepared to voice our opposition to the detractors, especially when they have nothing other than unsubstantiated evidence themselves.

The "game" of pharmaceutical chess and the commercial pressures are only too real and tend to be ignored, whilst the principled argue and debate about what is the correct approach and how, and on what, judgements should be made. Principled debate is all very well but not if you forget that there are big players out there who make up their own rules and couldn't give a damn about being correct - just more profitable!

Regards, Mark

Well here I am 10 years later and on novatrone after trying many others. Now dissabled and crossing my fingers that aimspro becomes avlable for Dr's to prescribe to M.S. carriers around the world.

SickSickly

Hi all,

The following had been sent for posting on the Proventus website last week but, owing to email rather than phone communication, I was unaware that our web designer was out of the country for 2w and therefore out of the loop. As the lack of fresh content on the site has caused disquiet in some quarters, I have opted not only to try an find another work-around but also to put this posting directly onto the forum. It may not be the full outcome of the MHRA's discussions with Daval as that is still to be pronounced upon by the MHRA but it is at least of relevance. The posting is to be linked from the news page and reads as follows: -


Abstract from the Optic Neuritis trial paper
(with additional comments in italics).


The evaluation of a novel ‘goat serum’ therapy (Aimspro) in multiple sclerosis


Background: Anecdotal reports suggest dramatic immediate clinical improvement when HIV / B3 cell supernatant inoculated goat serum (Aimspro) is given to patients with Multiple Sclerosis (MS).


Objectives: This is the first randomized, double-blind, placebo-controlled study of this treatment and was designed to explore the effect of short-term administration of Aimspro in MS patients with fixed optic nerve dysfunction.


Methods: Twelve subjects (mean age 40.4 years, range 27-50, median EDSS 4, 7 females and 5 males) with clinically definite MS (6 RR, 5 SP and 1 PP) and a history of optic neuritis more than three months prior to the study, with residual visual impairment were recruited. Objective neurophysiological, functional magnetic resonance imaging and visual field assessments were performed and results compared between the two groups (Aimspro versus placebo). The study was powered to detect a 0.5% change in the fMRI primary outcome, with an estimated standard deviation of 0.4%, allowing for 10% subject dropout.


Results: Both Aimspro and placebo were well tolerated and there were no serious adverse events. Treatment with Aimspro showed no significant benefit in the primary or secondary outcomes: visual evoked potential amplitude or latency, or the amplitude of the BOLD response in the fMRI experiments. There was a significant treatment effect in the tertiary outcome of visual field function (p=0.02).


Conclusions: This study was exploratory and only measured immediate change after three treatment doses. The major visual deficit in most patients was peripheral and the only outcome that assessed this area significantly improved with treatment. These results are encouraging and support the need for further clinical trials.



J. A. Palace, G. Burke, A. Cavey, P.M. Matthews
University Dept. of Clinical Neurology

Radcliffe Infirmary

Woodstock Road

Oxford. OX2 6HE, UK

(Funding for the study was provided by Daval International Ltd., who own the patent on Amispro. However, the study was designed independently by the investigators, who were responsible for the conduct, analysis and interpretation of the results.)



Essentially there were 3 outcome measures in the trial but these were not necessarily in order of importance, just convention. Certainly the primary and secondary ones (VEP & fBOLD measurements) showed no change in response to treatment and the tertiary one (visual fields, which was "the major visual deficit" in the test subjects) was clearly improved but without being "dramatic" or "outstanding". These were objective and scientifically measurable features - what wasn't measured or reported on were the subjective results as perceived by the test subjects themselves.

It says in the discussion of the results towards the end of the full paper,
"For these reasons, only a dramatic improvement in visual function would be expected to show a significant treatment effect in these parameters."
- VEP & BOLD (ie. you can still have definite subjective improvement without a correspondingly good objective measurement) and,
"Furthermore, since fewer fibres originate from the periphery, reducing damage to just a few fibres may result in a detectable improvement in peripheral visual function."
- (ie. beneficial effects in a lower number of fibres - and therefore harder to measure - can still give an important change for the better to the patient).

In other words there are very good reasons why the correlation between the first two outcome measures and the subjective benefits in sight to the test subjects is not direct and linear. In plain english this means that any improvement that a patient may notice is not automatically reflected in what the scientists can measure. Vice-versa, a "no improvement" outcome measurement can still be experienced as a very worthwhile improvement to the patient. The choice of outcome measures doesn't seem to have been especially intuitive in hindsight but then again these have to be chosen in the design stage of the trial and not once the effects have been seen.

Other comments on these results posted elsewhere on the web seem to focus on the key statement of "no improvement in the primary and secondary outcome measures" rather than on what was experienced by the subjects, who apparently all reported a subjective improvement in vision on Aimspro. It would seem, at least in some regards, better to have a treatment that enabled a patient to "see" an improvement (irrespective of what the scientists' measurements said) than one which showed results in the laboratory but left the patient unaware of any change in their sight.

Proventus accepts the vital role of clinical research in assessing Aimspro but it should not be forgotten that patients are the ultimate beneficiaries of any success and not scientific instruments. Nor should an understanding of any research results be based on phrases taken from articles quite out of context - it must be made in the round and with a reasonably full comprehension.

- Finally, a comment from one of Proventus' members on the informed consent list...
"Furthermore, this trial was carried out over a very short time span (3w) and, from our own personal experience, I feel there was insufficient time to evaluate the true potential of the treatment, i.e. although my wife had an almost instant recovery with respect to the squint in her left eye, it was only after eight weeks of treatment that the visual blurring had cleared and it was several months more before she could tolerate bright sunlight."

I'm from Canada and I'm looking for someone taking Aimspro?

you are so wrong \I don't care what any one says i took this drug and it's a miracle drug by far!!!I took my first 2 shots in my stomach and with in 15min. my hands were not shaking at all when they were going so fast was hard 2 see them .the second day i took the shots i was ables 2 jump off the ground and jog/run which i wasnt able 2 for 7years at the time.I'm a christian man and this drug is a miracle which i have no reason 2 make any of this up.i HAVE NO IDEA WHY THEIR HAVING PROBLEMS WITH GET PASSED PHASE 2 EXCEPT THE DRUG COMPANYS MONEY MONEY THIS DRUG WOULD TAKE OUT EVERY DRUG FOR MS ON THE MARKET AND THIER WOULD B NONE LEFT EXCEPT THIS ONE.THAT'S HOW GOOD THIS DRUG IS,

The reason it has not been approved, is because it has not succeeded in double blind trials

As with most if not all MS meds, specific ones work for one group, and fail for others. This medication does not work as well as it did for you, for everybody. I personally tried it, and got little (*possibly* a very small reduction in tingling) if any benefit from it.

I really don"t understand why the goe rnment has such a p roblem with this grug and sf1019.I been on them and a friend of mine and have tried most drugs on the market and nothing compares 2 this by far.T heir is no limit on the amount of money i would spend 2 get this drug again.I guess when you go from not being able to jog,run,hands shaking nonstop,being sick and extreme pain,who woul'nt .I would say it took 70percent of that away and made it managable t o live.i now am confined 2 my condo and don't leave my couch to where it's very hard to even get stuff around the house done.I had no side effects on these drugs what so ever as well as my friend.I don't care what any study sdays i know this works and i believe it should be my own choice if i want to take it even if it did have risks.This count ry is a jk and it's all about money which would wipe out billions in all the other drugs cause they wouldnt stand a chANCE AGAINST IT.I do feel blessed 2 have been able 2 been on it for a short term even though it was a tease it still gives me some hope their's drugs that stop the symptoms.WE ALL NEED 2 GET 2GETHER AND DO SOME THING TO GET THIS DRUG OUT ON THE MARKET

THER UNITED STATES/FDA WILL NOT EVEN LET THIS DRUG OUT WHAT SO EVER AND WONT EVEN LET THE UK TRY OR EVEN GET PASSED 1 PHASE. I WOULD LOVE FOR SOME 1 TO EXPLAIN THAT ONE!!!!!!!!!!!!!!!

If you want access, the details are on their website:
http://www.davalinternational.com/named_patient_programme.html

And as for the FDA not allowing access:
http://www.davalinternational.com/regulatory_status.html


It was interesting to read all the Orphan Drug designation provided by the TGA (basically Australia's equivalent to the FDA)

So, as far as I can tell, as it was for myself a few years ago, if you can find a compassionate GP, the drug is available on the market for purchased. But it ain't cheap.

And anyone who thinks its all puppy dogs and fairies, should read the following for perspective:
http://www.thisisms.com/forum/aimspro-f29/topic3462.html