Antisense VLA-4 inhibitor starts Phase II trials

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Antisense VLA-4 inhibitor starts Phase II trials

Postby dignan » Tue Dec 21, 2004 10:28 am

Antisense Therapeutics Limited and Isis Pharmaceuticals Initiate Phase 2a Trial of Antisense Drug for Multiple Sclerosis
Tuesday December 21, 7:55 am ET

PRNewswire-FirstCall - Antisense Therapeutics Limited and Isis Pharmaceuticals announced today the initiation of a Phase 2a clinical trial of ATL1102 in patients with multiple sclerosis (MS).

ATL1102 is a second-generation antisense inhibitor of an immune system protein called VLA-4 (alpha-4 integrin chain; CD49d). ATL1102 is designed to block the synthesis of VLA-4 which is known to play a part in both the onset and progression of MS.

"We are pleased to move ATL1102, our lead drug candidate, into patient trials," said Mark Diamond, Managing Director of Antisense Therapeutics. "VLA-4 is a clinically validated target in MS and antisense inhibition of VLA-4 has demonstrated positive effects in multiple animal models of inflammatory diseases, including MS. This Phase 2a trial will provide important efficacy data on ATL1102 and thereby, an indication of our compound's potential as an effective treatment for MS."

"ATL1102 represents a novel therapeutic approach to the treatment of MS and I am delighted to be associated with clinical trials using a technology that aims to stop the production of the disease causing protein, rather than deal with it after it is produced in the body," said Professor Volker Limmroth of the University of Essen Germany, an eminent Professor of Neurology, internationally recognized clinical expert on MS, and Principal Investigator for this Phase 2a study. "ATL1102 may have clinical advantages over currently available MS treatments and my co-clinical investigators and I will be attempting to elucidate these in the next several months as the trial progresses."

In this multi-center, randomized, double-blinded, placebo-controlled clinical trial, approximately 60 patients with relapsing-remitting MS will receive ATL1102 or placebo over eight weeks. ATL1102 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 2a trial is to obtain preliminary evidence of the drug's effectiveness which will be evaluated using MRI (magnetic resonance imaging) indices. MRI's will be conducted at monthly intervals over the 8 week dosing period and at monthly intervals during the 8 week period following completion of dosing.

MRI is a non-invasive technique which allows physicians to monitor the effects of drug therapy on the brain lesions of MS patients, and has now become the accepted clinical end-point for evaluating drug effectiveness in early-phase MS clinical trials. These indices permit an evaluation of the degree of disease-related injury in the central nervous system (CNS), and any treatment-related modification brought about following administration of a drug.

The Phase 2a trial has been initiated on schedule at the University of Essen in Germany following the approval of the Clinical Trial Application by the Institutional Review Board and Ethics Committee of the University. The trial has also been authorised by the Federal Institute for Drugs and Medical Devices (Bundesinstitut fur Arzneimittel und Medizinprodukte, BfArM) in Germany.

Antisense Therapeutics Limited has provided guidance that the treatment and patient monitoring stages of the trial are expected to be complete by early 2006, assuming patient recruitment proceeds at the anticipated rate. Antisense Therapeutics Limited anticipates reporting results by mid-2006.

About MS and ATL1102

MS is a life-long chronic, incurable autoimmune disease that progressively destroys the CNS. It is commonly diagnosed between the ages of 20 and 40 years. According to the U.S. National Multiple Sclerosis Society, approximately 400,000 Americans acknowledge having MS, and every week about 200 individuals are diagnosed. Worldwide, MS may affect more than two million people.

ATL1102 is an inhibitor of CD49d, a sub-unit of VLA-4 (Very Late Antigen-4). In MS, white blood cells (leukocytes) are directed 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. One VLA-4 inhibitor has recently been approved for marketing in the U.S. for the treatment of MS, and several other VLA-4 inhibitors are in clinical development for inflammatory conditions. Isis discovered this compound and licensed it to Antisense Therapeutics Limited in 2001.
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