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New MS treatment shows promising results

A treatment for multiple sclerosis that rebalances the immune system has been successful in early clinical trials and could prove a new way for treating patients with a progressive form of the disease.

A treatment for multiple sclerosis (MS) that rebalances the immune system has been successful in early clinical trials and could prove a new way for treating patients with a progressive form of the disease. 

The vaccine, developed by UK biopharmaceutical company Apitope, works by retuning the immune system so it no longer overreacts to patientsí own myelin protein. This offers  the promise of fewer side-effects than existing MS drugs. 

Current MS therapies work to either to suppress the immune system or reduce the inflammation around the nerve cells to counteract further damage. These treatments usually involve significant side-effects and susceptibility to other diseases and infections. 

Final results of a phase I/IIa clinical trial of ATX-MS-1467 have been revealed, showing a significant down regulation of the T-cell response to the autoantigen (myelin basic protein) whilst the important normal immune responses were left unchanged.

The trial was not designed to show efficacy but showed preliminary evidence of a positive clinical response to ATX-MS-1467 in two of the six patients. 

One patient with optic neuritis resulting from the neuroinflammatory process involved in MS continues to demonstrate a clinically significant improvement in visual acuity post treatment. Additionally, a second patient has shown improvement in the Gd-enhanced MRI scan indicating a reduction in neuroinflammatory processes in the brain.

"These preliminary clinical and immunological data are very encouraging and support the preclinical and scientific evidence on which this product is based", said Professor David Wraith, CSO of Apitope and professor of experimental apahology at the University of Bristol.

The treatment is a therapeutic peptide vaccine and was found to be safe and well tolerated by Secondary Progressive (SP) MS patients with no treatment-related serious adverse or adverse events reported. 

A final phase II trial of ATX-MS-1467 is expected to begin by Q4 2008 and Apitope expects full results within two years of the trial start. This trial will be designed as a double-blind placebo controlled study in MS patients with the more frequently encountered relapsing remitting form of MS. 

An initial was completed in November 2007 and was followed by a three-month safety and tolerability examination of each SPMS patient. 

The phase I/IIa open label trial was designed as a dose-escalation study to assess the safety and tolerability with all six patients receiving five escalating doses given 7 to 14 days apart of 25, 50, 100, 400 and 800 followed by a repeat of the 800 microgram dose.

Along with development of ATX-MS-1467, Apitope is continuing development of a diagnostic blood test for MS and expects to complete the clinical validation in patients with all forms of MS in the next 12 months.

30th January 2008

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