4 February 2003
Source: Antisense Therapeutics
A new treatment for Multiple Sclerosis (MS) under development by Australian company Antisense Therapeutics Limited (ASX:ANP) will be tested in humans following the approval received today from the Institutional Review Board and the Ethics Committee of the UK Clinical Research Organisation contracted to undertake the study.
Antisense Therapeutics expects to begin the Phase I human trial of ATL1102 in March of this year at Charterhouse Clinical Research Unit at Stamford Hospital in London. This trial will comprise of an evaluation of the safety and behaviour (pharmacokinetics) of single escalating doses of ATL1102 given by injection to 42 healthy human male volunteers.
“We are pleased to announce that we are on schedule to trial our first antisense compound in humans. The development of this drug has been rapid, having moved from the pre-clinical animal phase into human studies in a little over one year,” said Mark Diamond, Managing Director of the Company.
“This accelerated development through drug discovery and research into human trials is a major feature of the antisense technology utilised in our drug discovery programs, and also reflects the quality of our collaboration partnerships and the efficiency of our virtual business structure to optimise development outcomes.”
In October 2002 Antisense Therapeutics announced the successful completion of a package of pre-clinical (animal) studies, including toxicology and pharmacokinetics, which enabled the company to apply for approval to test ATL1102 in humans.
The results of the trials of ATL1102 in animals demonstrated the exciting prospect of administering ATL1102 to humans as infrequently as once a week or even less frequently, providing a more convenient and acceptable treatment for patients with MS. The likelihood of this dosing regimen, along with aspects of the product’s safety, will be assessed in this initial human study.
Following the successful completion of this trial, it is anticipated that an application will be made in 2004 for a Phase IIa trial to assess preliminary efficacy in patients with MS.
Multiple sclerosis is a chronic, incurable disease that progressively destroys the central nervous system, and is commonly diagnosed between the ages of 20 and 40 years.
MS affects about 350,000 people in the US where the estimated annual cost of the disease is more than US$2.5 billion. Although current treatments with steroids are unable to slow disease progression, they decrease the duration of attacks.
How antisense works
In the cell, DNA is copied to produce mRNA, which is translated to produce a protein. Proteins carry out functions inside the cell. A well-known protein is insulin.
An antisense drug binds to a segment of mRNA and prevents production of the protein. An antisense drug is specific to this segment of mRNA produced from the gene being targeted. Through its action on mRNA, antisense prevents a protein responsible for the disease process being made and may prevent the progression of the disease.
For example, our antisense drug ATL1102 for MS targets an immune cell protein called VLA-4. VLA-4 protein has been shown to contribute to the progression of MS. The antisense mechanism aims to prevent the production of this protein by binding to the specific segment of mRNA that is responsible for its production.
Antisense Therapeutics Limited
Antisense Therapeutics Limited is an Australian publicly listed biopharmaceutical drug discovery and development company. The Company’s mission is to create, develop and commercialise novel antisense pharmaceuticals for large unmet markets. Its two most advanced projects target Multiple Sclerosis (ATL 1102) and Psoriasis (ATL 1101).
The Company’s access to these projects is derived from its technology and research collaborations with Isis Pharmaceuticals Inc and the Murdoch Childrens Research Institute. Californian based Isis is a world leader in the field of antisense drug technology.
The collaboration agreement with Isis provides the Company with an extensive package of access to Isis’s antisense drug discovery relevant to the treatment of viral, skin, growth and inflammatory disorders. Antisense Therapeutics plans to commercialise its pipeline via licensing/collaboration agreements with major biotechnology and pharmaceutical companies.
Antisense Therapeutics’ major shareholders include Circadian Technologies
Limited, Isis Pharmaceuticals
Inc, Queensland Investment Corporation and the Murdoch Childrens Research
© Copyright 2003, Antisense Therapeutics Ltd