ANP 5.88% 18.0¢ antisense therapeutics limited

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  1. 130 Posts.
    re: read announcement 27 August 2003
    The Companies Section
    The Australian Stock Exchange Limited
    530 Collins Street
    Dear Sir/Madam
    Investor Update Re Multiple Sclerosis Compound
    - Initiation of Phase I Study
    In line with a recent update provided in the Company¡¦s corporate presentation on 13 August
    2003, Antisense Therapeutics yesterday commenced dosing of healthy volunteers in Phase I
    clinical studies of its multiple sclerosis product, ATL1102 at the Company¡¦s contracted
    clinical trial centre, Charterhouse Clinical Research Unit, Ravenscourt Park Hospital
    (formerly Stamford Hospital) in London. Antisense Therapeutics licensed ATL1102 from
    California-based Isis Pharmaceuticals Inc (¡¥Isis¡¦) in 2001. ATL1102 is an exciting secondgeneration
    antisense compound, and our partner, Isis is to jointly announce with Antisense
    Therapeutics the initiation of this Phase I trial to the US market.
    As announced by Antisense Therapeutics on 4 February 2003, this human trial is comprised
    of an evaluation of the safety and disposition (pharmacokinetics) of single escalating doses of
    ATL1102 given by injection to approximately 40 healthy volunteers. Antisense Therapeutics
    anticipates reporting the results of this trial by mid 2004. For further information refer to the
    Antisense Therapeutics/Isis joint announcement which follows.
    Yours sincerely
    Natalie Korchev
    Company Secretary
    Contact Information:
    Managing Director ¡V Mark Diamond +61 3 9827 8999
    Company Secretary ¡V Natalie Korchev +61 3 9827 8999
    Contact: Kristina Peterson
    Isis Pharmaceuticals
    Natalie Korchev
    Antisense Therapeutics Limited
    +61 3 9827 8999
    Melbourne, Australia and Carlsbad, CA, USA, August 27, 2003 ¡V Antisense Therapeutics
    Limited (ASX:ANP) and Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) 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 human clinical trials in the
    past 18-months,¡¨ said Stanley T. Crook, 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), 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
    human 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
    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.
    Antisense Therapeutics Ltd. is an Australian publicly listed (ASX: ANP) biopharmaceutical drug
    discovery and development company. ATL¡¦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).
    ATL¡¦s access to these projects is derived from its technology and research collaborations with
    Isis Pharmaceuticals Inc. and the Murdoch Childrens Research Institute (MCRI). The MCRI,
    based at the Royal Children¡¦s Hospital in Melbourne, is a major Australian research institute
    with over 450 staff and operates as an independent non-profit organisation. California-based Isis
    is a world leader in the field of antisense drug technology. The collaboration agreement with Isis
    provides ATL with extensive access to Isis¡¦ antisense drug discovery technology of relevance to
    the treatment of viral, skin, growth and inflammatory disorders. ATL plans to commercialize its
    pipeline via licensing/collaboration agreements with major biotechnology and pharmaceutical
    ATL¡¦s major shareholders include Circadian Technologies Limited (ASX: CIR), Isis
    Pharmaceuticals Inc., Queensland Investment Corporation and the Murdoch Childrens Research
    Isis Pharmaceuticals, Inc. is exploiting its expertise in RNA to discover and develop novel
    human therapeutic drugs. The company has commercialized its first product, Vitravene(R)
    (fomivirsen), to treat CMV-induced retinitis in AIDS patients. In addition, Isis has 11 antisense
    products in its development pipeline, with two in late-stage development and several in Phase II
    human clinical trials. Affinitak(TM) (formerly called LY900003 and ISIS 3521), an inhibitor of
    PKC-alpha, is in Phase III development for non-small cell lung cancer, and alicaforsen (ISIS
    2302), an ICAM-1 inhibitor, is in Phase III clinical trials for Crohn's disease. Isis has a broad
    patent estate, as the owner or exclusive licensee of more than 1,200 issued patents worldwide.
    Isis' GeneTrove(TM) program uses antisense to assist pharmaceutical industry partners in
    validating and prioritizing potential gene targets through customized services. The Ibis
    Therapeutics(TM) program is focused on the detection of infectious organisms and the discovery
    of small molecule drugs that bind to RNA. Additional information about Isis is available at
    This press release contains forward-looking statements about the potential of the investigational
    compound ATL1102 for multiple sclerosis, Isis Pharmaceuticals¡¦ collaboration with ATL and
    the potential of Isis¡¦ drug development programs. Any statement describing a goal, expectation,
    intention or belief of the company is a forward-looking statement and should be considered an
    at-risk statement. Such statements are subject to certain risks and uncertainties, particularly
    those inherent in the process of discovering, developing and commercializing drugs that are safe
    and effective for use as human therapeutics and financing such activities. Actual results could
    differ materially from those projected in this 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 on Form 10-Q for the period ended June
    30, 2003, which is on file with the U.S. Securities and Exchange Commission, copies of which
    are available from the company.
    VitraveneÆÊ is a registered trademark of Novartis AG.
    GeneTroveÆË and Ibis TherapeuticsÆË are trademarks of Isis Pharmaceuticals, Inc.
    AffinitakÆË, a trademark of Eli Lilly and Company, is an investigational cancer compound being
    developed through an alliance between Lilly and Isis Pharmaceuticals, Inc. and marketed
    globally by Lilly.
    # # #
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