Finance Story - Antisense Therapeutics Limited and Isis Pharmaceuticals Initiate Phase 2a Trial of Antisense Drug for Multiple Sclerosis

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Antisense Therapeutics Limited and Isis Pharmaceuticals Initiate Phase 2a Trial of Antisense Drug for Multiple Sclerosis

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Press ReleaseSource:

Isis Pharmaceuticals, Inc.

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

MELBOURNE, Australia, and CARLSBAD, Calif., Dec. 21

/PRNewswire-FirstCall/ -- Antisense Therapeutics Limited (ASX: ANP - News) and IsisPharmaceuticals, Inc. (Nasdaq: ISIS - News) announced today the initiation of aPhase 2a clinical trial of ATL1102 in patients with multiple sclerosis (MS).ATL1102 is a second-generation antisense inhibitor of an immune system proteincalled VLA-4 (alpha-4 integrin chain; CD49d). ATL1102 is designed to blockthe synthesis of VLA-4 which is known to play a part in both the onset andprogression of MS.ADVERTISEMENT

"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 ATL1102MS 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.About Antisense Therapeutics LimitedAntisense Therapeutics Limited is an Australian publicly listed

biopharmaceutical drug discovery and development company (ASX: ANP - News). ANP's

mission is to create, develop and commercialize novel antisense

pharmaceuticals for large unmet markets. Its two most advanced projects

target Multiple Sclerosis (ATL1102), and Psoriasis (ATL1101). ANP plans to

commercialize its pipeline via licensing/collaboration agreements with major

biotechnology and pharmaceutical companies. The company's major shareholders

include Circadian Technologies Limited (ASX: CIR - News), Isis Pharmaceuticals, Inc.,

and Queensland Investment Corporation. Further company details are available

on the Antisense Therapeutics website at www.antisense.com.au.About Isis Pharmaceuticals, Inc.Isis Pharmaceuticals, Inc. is exploiting its expertise in RNA to discover

and develop novel human therapeutic drugs for its pipeline and for its

partners. The company has successfully commercialized the world's first

antisense drug and has 10 antisense products in development to treat

metabolic, cardiovascular, inflammatory and viral diseases, and cancer.

Through its Ibis Therapeutics® program, Isis is developing a biosensor to

identify infectious organisms, and is discovering small molecule drugs that

bind to RNA. As an innovator in RNA-based drug discovery and development,

Isis is the owner or exclusive licensee of more than 1,400 issued patents

worldwide. Additional information about Isis is available at

http://www.isispharm.com.This press release includes forward-looking statements regarding Isis

Pharmaceuticals and Antisense Therapeutics Limited's drug development

collaboration and the development, therapeutic potential and safety of ATL1102

in treating multiple sclerosis. Any statement describing our goals,

expectations, intentions or beliefs is a forward-looking statement and should

be considered an at-risk statement, including those statements that are

described as Isis' clinical goals. Such statements are subject to certain

risks and uncertainties, particularly those inherent in the process of

developing technology, in discovering and commercializing drugs that are safe

and effective for use as human therapeutics, and in the endeavor of building a

business around such products. Actual results could differ materially from

those discussed in this press release. As a result, you are cautioned not to

rely on these forward-looking statements. These and other risks concerning

Isis' research and development programs are described in additional detail in

Isis' Annual Report on Form 10-K for the year ended December 31, 2003, and

quarterly report on Form 10-Q for the quarter ended September 30, 2004, which

are on file with the U.S. Securities and Exchange Commission. Copies of these

and other documents are available from the company.Ibis Therapeutics® is a registered trademark of Isis Pharmaceuticals,

Inc.

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