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..."

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Research and Development are now the main thrusts of Daval International Ltd, and clinical aspects are now headed up by Dr Bryan Youl, a London based Consultant in Clinical Neurophysiology with a special interest in demyelinating diseases of the Nervous System. While it was the process of clinical observation in informed consent patients three to four years ago that originally led to the establishment of two double-blind, placebo controlled trials in Multiple Sclerosis, the current emphasis resides in the transfer of the findings from laboratory based research (human cell culture studies and neurophysiology) into the clinical arena.

As a result of this approach six international figures in academic neurosciences (in the UK, Australia and New Zealand) have joined in the scientific program. Prof. Angus Dalgleish’s team at the St George’s Hospital Medical School, London led by Dr Deirdre McIntosh is at the forefront of the non-clinical research effort.

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.

While exciting prospects for the use of AIMSPRO in Multiple Sclerosis itself drive the R and D activity of the company, the laboratory findings generated by non-clinical researchers have led to the hope of finding efficacious approaches to the treatment of other disabling conditions. A randomised double-blind placebo controlled study in Rheumatoid Arthritis has received the appropriate approval and is about to commence at the St George’s Hospital.

Early findings in patients with a very rare disorder of peripheral nerves also make Dr Youl optimistic about broadening the eventual applications of the product. Collaboration between British and Australian neurologists is underway in this regard, and in total, 15 Consultant Neurologists and Neurophysiologists, and three Consultant Rheumatologists are collaborating in the programme. A senior consultant surgeon has recently joined the team given certain promising observations in wound healing. On top of this, work on characterisation and stability of the product, both essential matters in regard to the eventual licensing of AIMSPRO, is proceeding apace. Careful attention is being applied to safety matters at all stages.

Dr Youl says,

“We are now dependent on the ingenuity of our scientific and clinical colleagues with a view to better defining the medication, confirming its safety profile and to determining ideal dosage and administration schedules. One can only be encouraged by the progress to date in each of these areas”.

Recruitment for the first two Multiple Sclerosis trials has now been completed, but announcements will be made on this website as to the outcome of the Ethics Committee application for the third trial and eventually, as to the recruitment criteria.

August 5,

Dr Bryan Youl BMedSc, MBBS, MD, FRACP, FRCP, FRSM NHS Consultant in Clinical Neurophysiology

Originally found: http://www.davalinternational.com/markup/randd.cfm