Feb. 2, 2004
Source: Antisense Therapeutics Limited
Antisense Therapeutics Limited, a biopharmaceutical company today announced that preliminary data from its Phase I human clinical trials on ATL1102, Antisense Therapeutics' second generation antisense drug for multiple sclerosis (MS), was presented at the Australian Neuroscience Society Scientific Conference in Melbourne on January 30.
Dosing is completed in both single and multiple dose Phase I trials. The aims of the Phase I trials are to obtain information on the pharmacokinetic behavior of ATL1102 in humans and to assess the safety and tolerability of increasing dose levels of ATL1102.
Blood and other biological samples are being collected from every individual to measure safety parameters and the blood level concentrations of the delivered drug and safety parameters over prolonged periods of time (lasting several months after dosing). Laboratory analyses and collection of the biological samples are still continuing and full and final results are expected to be reported mid-year.
Preliminary indications from the data collected and analysed so far are favorable for both safety and pharmacokinetics.
These indications provide Antisense Therapeutics with the confidence to begin planning the Phase IIa clinical trials in MS patients with the selection of appropriate dose levels and dosing regimens. At present, study designs for the Phase IIa clinical trial are being discussed with potential clinical trialists and contract organizations.
Once final reports are received for the Phase I trial and the results are assessed as satisfactory, the Company will make an application for the Phase IIa patient trial.
Regulatory agency approval and commencement of the Phase IIa trial are targeted for the second half of 2004.
A copy of the PowerPoint presentation made to the Australian Neurosciences Conference is available on the Antisense Therapeutics website http://www.antisense.com.au.
Multiple Sclerosis (MS) is a life-long chronic, incurable disease that progressively destroys the central nervous system. It is commonly diagnosed between the ages of 20 and 40 years. MS affects about 350,000 people in the US where the estimated cost of the disease is more than US$2.5 billion. Although current treatments are unable to slow disease progression, the aims of therapy are to reduce the duration, frequency and severity of attacks.
ATL1102 is a drug under development by Antisense Therapeutics, which aims to prevent the synthesis of a protein called VLA-4 known to play a part in both the onset and progression of MS.
Antisense Therapeutics Limited is an Australian publicly listed biopharmaceutical
drug discovery and development company. 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, Isis Pharmaceuticals
Inc., Queensland Investment Corporation and the Murdoch Childrens Research
Institute. Further details are available on the Antisense Therapeutics
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