MELBOURNE, Australia, Jan. 18 /PRNewswire-FirstCall/ -- Antisense Therapeutics Limited has received approval from the Ethics Committee of the University of Essen in Germany to restart the Phase IIa trial of its antisense compound, ATL1102, for patients with relapsing-remitting Multiple Sclerosis. The University of Essen is the primary trial site for the Phase IIa clinical trial. Patient enrollment and dosing are expected to commence at this center in the February/March timeframe.
This multi-center, randomized, double-blinded, placebo-controlled Phase IIa clinical trial is designed to assess the activity and safety of ATL1102 in 80 MS patients. The drug will be delivered by subcutaneous injection on a twice-a-week dosing schedule at a dose of 400 mg per week. The goal of the Phase IIa trial is to obtain preliminary evidence of the drug's effectiveness, which will be evaluated using MRI indices. MRI's will be conducted at monthly intervals over the eight-week dosing period and at monthly intervals during the eight-week period following completion of dosing.
The treatment and patient monitoring stages of the trial are expected to conclude by the end of 2006, assuming patient recruitment proceeds as scheduled. The University of Essen will be the primary site for the trial, with eight other trial centers in Germany to be initiated in the coming months.
"We are pleased to receive approval from the University of Essen to restart the Phase IIa trial and advance the development of ATL1102," said Mark Diamond, Chief Executive Officer. "This follows the unanimous recommendation we received to continue the development of the compound as a treatment for patients with MS from the independent Medical Advisory Board that we convened last March to evaluate the most appropriate development path for the drug. ATL1102 represents a novel therapeutic approach to the treatment of MS, which as stated by the Medical Advisory Board, appears to have significant potential as a therapeutic agent for patients with the relapsing-remitting form of the disease."
Multiple sclerosis is a life long chronic disease of the central nervous system, which is believed to affect as many as 2.5 million people worldwide. While existing drug sales for this disease were greater than US$4 billion in 2004, there remains a high demand for more effective and better-tolerated treatments.
About ATL1102 for MS
ATL1102 is a second-generation antisense inhibitor of CD49d, an immune system protein known as VLA-4 (Very Late Antigen-4), and is currently in development as a treatment for MS. The Antisense compound is designed to block the synthesis of VLA-4, which is known to play a part in both the onset and progression of Multiple Sclerosis. In inflammation, white blood cells (leukocytes) move out of the bloodstream into the inflamed tissue, for example, the CNS in MS, and the lung airways in asthma. The inhibition of VLA-4 may prevent white blood cells from entering sites of inflammation, thereby halting progression of the disease. Antisense inhibition of VLA-4 has demonstrated positive effects in a number of animal models of inflammatory disease including MS. The mechanism of action of ATL1102 in blocking VLA-4 is different to other drugs in development that target this same protein, including the monoclonal antibody Tysabri(R).
About Antisense Therapeutics Limited
Antisense Therapeutics Limited is an Australian publicly listed biopharmaceutical drug discovery and development company. ANP's mission is to create, develop and commercialise novel antisense pharmaceuticals for large unmet markets. The company's product pipeline includes ATL1102 for Multiple Sclerosis, and ATL1101 for Psoriasis, both of which have advanced to the stage of human clinical trials and ATL1103, a potential treatment for growth (acromegaly) and sight disorders (diabetic retinopathy and wet-are related macular degeneration), which is in pre-clinical development. For additional information about Antisense Therapeutics and the compounds it is developing, visit the company web site http://www.antisense.com.au.
ANP's major shareholders include Circadian Technologies Limited and Isis Pharmaceuticals Inc.
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Mark Diamond Kathy Price
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Antisense Therapeutics Limited