Aimspro - Trial in Oxford, England

[Guest guest]

Below is info on Aimspro, sorry its a very long post but

there has been a lost of interest in recent postings but

little real information.............

Kind regards,

Mark from Oxford England (not in the trial)

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The drug is an antibody derived from Goats serum

(or Aimspro is vaccine induced bioactive effector complex

(vibec) rigorously prepared from the serum of goats).

Lots of info is available on the company's website:

http://www.davalinternational.com

My comments:

" This is a small UK biotech company set up to develop this

drug which was discovered by a group of academics.

Aimspro is not a cure for MS but may be a life long treatment.

Do not expect a product release soon, Tysabri will make

the UK regulator more careful on MS treatments.

Duval stopped a trial in one London hospital because the

trail staff broke the trial procedure. "

Results from a trial from Oxford have been announced but

are yet to be published:

http://www.davalinternational.com/markup/news-pr-mar.cfm

SUCCESS OF OXFORD OPTIC NEURITIS TRIAL OFFERS FRESH

HOPE FOR MS SUFFERERS

- Aimspro produces ‘dramatic improvement’ in eyesight of MS

patients

Britain’s 80,000 Multiple Sclerosis sufferers have been given

fresh hope following the success of an independent clinical

trial of Aimspro.

MS patients with the condition Optic Neuritis – an

inflammation of the optic nerve and one of the most common

features of multiple sclerosis - were treated with Aimspro in

a recent clinical trial at Oxford University and the

Radcliffe Hospital.

Patients’ vision improved significantly following treatment

with Aimspro. The trial participants demonstrated

improvement in objectively measured visual field scores

over a two week course of treatment, under double blind

conditions - and they experienced no side effects as a result

of the treatment.

These highly significant improvements in the patients sight

were observed after only three sub-cutaneous injections –

and the possibility of a placebo effect was excluded.

This is the first time that any treatment has been shown

conclusively to reduce an aspect of disability in the chronic

phases of MS to this degree.

The Aimspro trial at the Radcliffe was a randomised,

double blind, placebo controlled, crossover trial,

independently designed and analysed by some of Britain’s

leading MS experts, including Prof. s. Patients

and researchers were ‘blinded’ as to whether participants

were receiving Aimspro or placebo. The crossover design

meant that each patient received two weeks (three

injections) of medication, and two weeks of placebo, each

phase separated by a ‘washout’ period.

In tertiary outcome measures, there was a significant

treatment effect on visual fields in both of the assessed

measures (p=0.02 for manual points score, p=0.03 for

Mean Deviation score). The report also mentions that the

treatment was 'well tolerated' (i.e. there were no significant

side effects).

Optic neuritis is a complication of MS where discomfort

behind the eye is followed by a loss of central vision

(particularly colour vision) as demonstrated using visual

field testing.

Generally patients’ vision recovers fully or partially as an

attack of MS on the optic nerve ceases, but some have

their sight permanently affected. The patients in the Oxford

trial had entered a chronic phase of visual loss, with little

chance of significant improvement. All the trial patients have

requested to remain on the therapy.

Dr Youl, a consultant in Clinical Neurophysiology at

the Royal Free Hospital in London, whose own findings on

the medication’s application in MS and other neurological

conditions are about to be published in the UK and Australia,

is hugely encouraged by the Oxford trial results.

“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.”

The Oxford trial confirms Dr Youl’s own findings in

observational studies carried out last year in London.

He said:

“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.”

He added:

“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”.

Dr Youl is now working with UK and Australian colleagues,

on confirming his early observations on the effect of Aimspro

in leucodystrophies, inherited and inflammatory peripheral

neuropathies, and a range of rheumatological disorders,

and muscle disorders.

Dr Youl has shown that patients with long standing

complications of optic neuritis can benefit from the medication,

which is given as an injection under the skin, in as little as

25 minutes. Simple neurophysiological tests verified that this

phenomenon results from a reversal of ‘conduction block’ in

optic nerve fibres. Dr Deidre McIntosh PhD has identified

molecules critical to the mechanism of action. Dr

FRCP has confirmed neuroscientists’ expectation that

modification of sodium channel triggering is critical to the

process.

The Oxford/ Radcliffe team intend to publish their

analysis of the trial results in a clinical scientific journal

later this year.

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