Phase I Trial of Antisense Drug for Multiple Sclerosis
Wednesday, August 27, 2003 - 10:48 AM PST
Antisense Therapeutics Limited and Isis Pharmaceuticals, Inc. announced today the initiation of a Phase I clinical trial of ATL1102 (ISIS 107248) for multiple sclerosis (MS). ATL1102 is an 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. Isis licensed the compound to Antisense Therapeutics Ltd. ("ATL") in 2001.
"We are pleased to move ATL1102, our lead drug candidate, into the clinical setting," said Mark Diamond, Managing Director of ATL. "This trial is the first step in potentially improving the treatment of multiple sclerosis, which is a major unmet medical need. We are hopeful that this antisense drug, the first to be developed for multiple sclerosis, may provide patients with a new treatment option, as current therapies are limited."
The double-blinded, placebo-controlled Phase I study will evaluate the pharmacokinetic and safety profile of ATL1102 in approximately 40 healthy volunteers. This trial is being conducted at the Charterhouse Clinical Research Unit of the Ravenscourt Park Hospital (formerly Stamford Hospital) in London.
"We are committed to the rapid advancement of Isis' proprietary second- generation antisense drugs. ATL1102 is our fourth second-generation compound to enter clinical trials in the past 18-months," said Stanley T. Crooke, M.D., Ph.D., Isis' Chairman and CEO. "This collaboration provides us with the opportunity to expand our pipeline through participation in the development of additional antisense drugs, while reducing expense and risk to Isis."
In December 2001, Isis and Circadian Technologies Limited (ASX: CIR - News), a leading Australian biotechnology commercialization firm, collaborated to create ATL. As part of the broad-based agreement, the companies established a five-year antisense drug discovery and development collaboration, which included Isis' license of ATL1102 to ATL. Isis manufactures drug for clinical trials for ATL at ATL's cost. ATL is responsible for the clinical development and commercialization of the compound.
Isis' proprietary second-generation drugs are designed to provide greater potency, increased stability, enhanced oral bioavailability and the potential for decreased side effects for patients. These attributes, along with advances in formulations, expand the therapeutic scope of antisense technology.
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.
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