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Aimspro® Phase 2B trial has been announced by Daval International Ltd. Daval has
received MHRA and IRB (Ethics Committee) approval for a London based Phase 2B trial
of its hyper-
The trial will be a double-blind placebo-controlled crossover study of bladder function
in Multiple Sclerosis patients.
This trial began Aug 2008
Aimspro has an export-
Daval International Ltd has recently been accepted as a member of the Association of the British Pharmaceutical Industry (ABPI).
In the US, Regulatory Consultants are supervising the first of two IND applications
which will include studies of two demyelinative indications. In Australia, three
trials, concerning an aspect of wound healing, a neuronopathy and a further demyelinative
indication, are about to enter the CTX process. A second MHRA CTA application has
been lodged for an anti-
While two of the prospective clinical trials relate to
common human medical conditions, the remainder are Orphan indications. It will be
recalled that AIMSPRO has already been awarded an Orphan Drug designation by the
TGA in Australia (Krabbe's disease).
MS - Background info.
MS is considered mostly as a relapsing / remitting disease. This means the symptoms come and go in waves. It is important to be aware that even when the symptoms aren't acting up, the disease may still be progressing.
Multiple Sclerosis is a label given by the medical community to describe a physical condition; it is not a diagnosis of a specific disease.
MS is the most common primary neurological disorder of young adults, affecting women more than men to a ratio of 2:1. This ratio is steadily increasing. In the USA it is considered to be 3:1. Currently, there is no one diagnostic test that determines whether a person has Multiple Sclerosis.
Bladder dysfunction, is common amongst MS people and can cause great discomfort and embarrassment to the sufferer. While the number of MS sufferers in the UK is said to be approx 85,000, this figure has never risen for the past ten years and clearly underestimates the scale of the disorder. Worldwide numbers are reported at anywhere between 2.5 and 4 million.
The real fact is nobody knows!
Despite many years of research, there is no answer as to what causes MS.
Opinions are diverse and may remain so, funding (as a percentage of money raised) for R&D is comparatively small, efforts to uncover a solution appear to be disjointed.
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