Antisense and Isis see positive results in MS trial
Melbourne, Australia-based Antisense Therapeutics and Isis Pharmaceuticals,of California, US have said that the results of a dose-escalating Phase I study of ATL-1102 appeared well-tolerated and that a Phase II clinical trial is expected to begin in the second half of 2004.
Melbourne, Australia-based Antisense Therapeutics and Isis Pharmaceuticals,of California, US have said that the results of a dose-escalating Phase I study of ATL-1102 appeared well-tolerated and that a Phase II clinical trial is expected to begin in the second half of 2004.
ATL-1102 is a second-generation antisense inhibitor of VLA-4 (Very Late Antigen-4). Inhibition of VLA-4 has been shown to have positive effects in multiple animal models of inflammatory diseases, including MS.
'We are pleased with the favorable results of this trial which, along with preclinical data, give us critical dose information allowing us to move confidently to the next stage of clinical development,' said Mark Diamond, Antisense Therapeutics' chief executive officer.
The double-blind, randomised, dose-escalation, placebo-controlled Phase I study evaluated the pharmacokinetic and safety profile of ATL-1102. In 54 healthy volunteers, ATL-1102 was either delivered in an intravenous (IV) or subcutaneous (SQ) formulation. ATL-1102 was well-tolerated. The most frequently reported side effects included mild 'flu-like' symptoms and occasional injection site reactions, which were generally mild and increased in incidence and severity with escalating dose levels, particularly at 12 and 18 mg/kg/week. 'These data are consistent with the results of other second-generation antisense drugs demonstrating the predictability of the antisense platform,' said Dr Stanley Crooke, chairman and ceo of Isis Pharmaceuticals. 'We continue to make excellent progress with our second-generation antisense drugs with results announced from three trials so far this year and we expect to continue that clinical momentum throughout 2004.'
Background Information
Multiple Sclerosis (MS) is a life-long chronic, incurable disease that progressively destroys the central nervous system. It is commonly diagnosed between the ages of 20 and 40 years. According to the National Multiple Sclerosis Society, MS is an autoimmune disease that affects the central nervous system (CNS). Approximately 400,000 Americans acknowledge having MS, and every week about 200 individuals are diagnosed. Worldwide, MS may affect more than two million people. ATL-1102 is an inhibitor of CD49d, a sub-unit of VLA-4 (Very Late Antigen-4). In MS, white blood cells (leukocytes) are pulled into the CNS from the blood. The inhibition of VLA-4 may prevent white blood cells from entering the CNS to stop the progression of MS. Inhibition of VLA-4 in animals has demonstrated positive effects on a number of inflammatory diseases such as MS. Several other VLA-4 inhibitors are in clinical development for inflammatory conditions. Isis discovered this compound and licensed it to Antisense Therapeutics in 2001.