Antisense eagerly awaits MS therapy result

As Biogen Idec and Elan await approval from the FDA and the European Medicines Agency for their multiple sclerosis therapeutic, Antegren, Melbourne-based Antisense Therapeutics (ASX:ANP) will also be watching with bated breath.

If approval is granted, Antisense will be riding a wave of good news, having confirmed last week that it's the Phase I studies for ATL-1102 -- targeted at the same VLA-4 antigen as Antegren -- showed its drug to be safe and well-tolerated at a 6mg per kg per week dose.

Antisense had presented preliminary data from the trial -- conducted at London's Charterhouse Clinical Research Unit -- at the Australian Neuroscience Society's annual conference in March. The placebo-controlled, randomised and double-blinded trial included 54 healthy male and female volunteer. ATL-1102 was delivered in both intravenous and subcutaneous formulations.

Side-effects reported included mild 'flu-like' symptoms and occasional injection site reactions -- increasing in incidence and severity as dose approached 12 and 18mg per kg per week.

"We are pleased with the favourable results of this trial which, along with pre-clinical data, give us critical dose information allowing us to move confidently to the next stage of clinical development," said Antisense CEO Mark Diamond.

Antisense is currently preparing an application to conduct a Phase IIa clinical trial in MS patients. European approval permitting, the trial is expected to be conducted in Europe during the second half of this year.

Biogen Idec's Antegren is a monoclonal antibody-based inhibitor which targets VLA-4, selectively preventing the movement of immune cells from the bloodstream into chronically inflamed tissues, which occurs in a variety of inflammatory diseases such as MS.

ATL1102 targets VLA-4 an earlier stage, thwarting the production of the VLA-4 protein. As with other antisense therapies, ATL1102 uses non-coding DNA to form double-stranded complexes with messenger RNAs, preventing them from being 'read' by ribosomes to produce the disease-causing protein.