It seems that the mediciation must not be allowed to thaw prior to injection-- and that protocol was simply not being followed by the pharmacy at the hospital. This would have likely led to an invalid and misleading trial result, so Daval took action. We hope this information puts many minds at ease, as the trial results for Aimspro in optic neuritis were indeed quite promising.

From Daval:

"The trial was halted because of concerns over St Georges Hospital’s pharmacy allowing the product "Aimspro" to thaw. This was in breach of all instructions given by Daval International. All other treatment programmes are completely unaffected."

Patients with chronic optic neuritis (inflammation of the optic nerve leading to vision disruption), were given 3 subcutaneous injections over 2 weeks. Apparently the results were positive, with minimal side effects:

" The trial participants demonstrated improvement in objectively measured visual field scores over a two week course of treatment, under double blind conditions...Within one hour of injection there was a significant improvement in colour vision, and comparison of pre-treatment and follow-up data also showed significant benefit.”

However, it later qualifies the results as "tertiary outcome measures"-- which leaves one curious as to what became of the primary and secondary outcome measures? This may be a simple misinterpretation and/or oversight on our part, but it is worth exploring in the coming weeks.

Probably more interesting still is the method of action of Aimspro. They claim that the results come very quickly ("one hour"!)-- which, given experience with traditional slow-acting immuno-modulating CRABs, must point to a different action for Aimspro.

Daval's theory is that the therapy is actually two-pronged: it immediately impacts nerve conduction, which leads to the quick results, and in the longer term has an anti-inflammatory action akin to traditional modes of action. A very relevant question is whether Aimspro actually slows/halts/reverses MS damage or "merely" works around it by improving nerve conduction. The statement mentions that the patients showed significant benefit in follow-up data, but does not quantify it. Happily, there is a promise of a significant additional findings (outside of this particular trial) that are "about to be published" regarding Aimspro's application in MS.

From Daval: “These trial results are hugely significant and have wider implications for the treatment of MS. Although this was a small trial, the Oxford Neurologists have shown that a brief course of three well tolerated sub-cutaneous injections of Aimspro, can demonstrably improve the condition of MS patients. And they echo other clinical observations which show this drug is able to improve mobility, bladder control and energy levels among MS patients.”

“Aimspro has a powerful and often rapid effect, producing dramatic improvement. We believe it to be restoring conduction in nerve and muscle fibres damaged by MS and other central and peripheral nervous system disorders, probably by an effect on biological structures within nerve and muscle known as voltage gated sodium channels.There is also clinical evidence to suggest that there may also be a repair process taking place in the longer term, which may reflect the medication’s powerful anti-inflammatory properties”.

This seems quite positive and hopeful that a relatively novel approach has been seen to benefit MSers-- we are, like all of you, anxious to learn more about Aimspro and will cover the developments with diligence.

Click "read more" for the full press release...

Quite frankly, our guess is as good as yours as to what in the world that might mean. Some honest guesses: The hospital was mishandling the drug delivery (not likely, as if a hospital cannot administer a drug correctly, who can?), or more likely, the hospital was not observing the blinding of the trial (placebo vs. therapy)? All conjecture at this point.

What we do know are the following:
1) This trial is now delayed indefinitely
2) The therapy is still being made available to the patients in the halted trial... presumably a good sign.

Pardon our humanity, but we feel we have all earned enough "karma" this week to have some sort of outrageous scientific breakthrough by the end of this month...

Please click "read more" to see the full (and mysterious) release...

They also seem to be starting up a trial for Rheumatoid Arthritis (RA). Interestingly enough, Elan is putting Antegren into trials for RA as well.

"The two Multiple Sclerosis trials are proceeding in the United Kingdom and government approval has been obtained for a third study – ethics committee applications are now underway and it is hoped that patient recruitment will begin in October. In this trial (and subject to Ethical approval) patients in relapse who prove resistant to currently accepted treatment regimens will be randomised to receive either oral prednisolone or sub-cutaneously injected AIMSPRO..."

Click "read more" for the full article...

"[Daval has] recently been approached by an individual seeking dosage advice for a “Goat Serum” purchased on the internet.

This “Goat Serum”, is not similar in any manner to that of the product used by Daval for the treatment of Multiple Sclerosis. It appears to be a research grade product which if injected would very likely cause death by anaphylactic shock.

“Aimspro”, which is made from the serum derived from a goat and whose immune system has been challenged in a very specific proprietary manner, has a very complex molecular structure which has been modified in order to make it acceptable for human use.

Daval does not sell any of its products on the Internet."