Apitope's ATX-MS-1467 shows positive immunological data in Multiple Sclerosis

Final Phase I/IIa data shows safety and tolerability, plus efficacy

05-Feb-2008

Apitope Technology (Bristol) Ltd., developer of peptide-based therapies for autoimmune diseases and allergy, announces today final results of a Phase I/IIa clinical trial of ATX-MS-1467 to treat multiple sclerosis (MS). Immunological analyses showed 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 therapeutic peptide vaccine was found to be safe and well tolerated in Secondary Progressive Multiple Sclerosis (SPMS) patients with no treatment related serious adverse or adverse events reported. Although the trial was not designed to show efficacy, there is 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.

The immunological analyses showed a reduction of up to 40% in myelin basic protein-induced T-cell proliferation one month after the course of treatment with ATX-MS-1467 while the T-cell response to PPD (a constituent of the BCG vaccine) was unchanged.

Apitope expects to begin a final Phase II trial of ATX-MS-1467 before the fourth quarter this year with full results expected within 24 months 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.

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