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Apitope Technology: MS vaccine shows promise in Phase I/IIa

Early results for Apitope Technology's multiple sclerosis vaccine are positive.

Apitope has reported results from its Phase I/IIa trial which suggest that its multiple sclerosis vaccine may be effective. Apitope is not the only small company developing a multiple sclerosis immunization, and as a novel treatment approach in a rapidly growing market, larger companies are likely to be monitoring the progress of this potential new treatment class closely. Apitope's recently completed Phase I/IIa open label trial of ATC-MS-1467 was designed as a dose-escalation study to assess the vaccine's safety and tolerability in six multiple sclerosis (MS) patients. Immunological results demonstrated a significant down-regulation of the T-cell response to the autoantigen, (myelin basic protein) while the important normal immune responses were left unchanged.

Furthermore, although the trial was not designed to show efficacy, one patient with optic neuritis resulting from the neuroinflammatory process involved in MS, demonstrated a clinically significant improvement in visual acuity post treatment and a second patient demonstrated improvement in an MRI scan, indicating a reduction in neuroinflammatory processes in the brain.

ATX-MS-1467 represents Apitope's most advanced pipeline product and the company expects to commence a final Phase II trial of the vaccine in relapse remitting MS patients before Q4 of this year, and for results to be available within 24 months of the trial start.

In addition to ATX-MS-1467, the current MS pipeline consists of two further vaccines which are in Phase II development; NeuroVax (Orchestra Therapeutics) and Tovaxin (Opexa Pharmaceuticals). All three of these pipeline vaccines are under development by small companies which lack the resources to independently bring these products to the market and commercialize them successfully.

Eli Lilly's recent licensing deal with BioMS for their pipeline MS candidate MBP-8298 demonstrates that large pharmaceutical companies are now looking towards the MS market as a source for future revenues. As such, Datamonitor believes that ATX-MS-1467, NeuroVax and Tovaxin all represent potentially attractive in-licensing opportunities.

Moving into immunization as a therapeutic strategy is becoming increasingly common in neurology, as demonstrated by the presence of Wyeth's bapineuzumab and Eli Lilly's LY2062430 in Phase III and II trials respectively for Alzheimer's disease. Estimated to be worth $5.2 billion across the seven major markets - US, Japan, France, Germany, Italy, Spain and the UK - in 2007, the MS market has shown consistently strong annual growth, and is estimated to be the largest neurology indication by value.

Related Research:

• Commercial Insight: Multiple Sclerosis - Continued growth makes the MS market a highly attractive investment

[edit] Sources

• Datamonitor