moe
14-11-2006, 12:27 PM
A bit of interest shown in ANP lately. A share placement to Overseas Institutional Investors announced yesterday. The Multiple Sclerosis trials look interesting. Anyone been following this one??
http://www.antisense.com.au/_home.asp
ATL1102 for Multiple Sclerosis
ATL1102 is a second generation antisense inhibitor targeting VLA4, an immune cell molecule. ATL1102 was acquired by Antisense Therapeutics from Isis Pharmaceuticals as part of their collaborative agreement.
VLA4 is a receptor on the surface of lymphocytes (a particular class of immune cells) which is important in immune cell adhesion to blood vessel walls and subsequent migration of lymphocytes into tissue - a key event in inflammatory diseases.
With Multiple Sclerosis, excessive amounts of VLA4 are believed to mediate the inappropriate migration of lymphocytes into the central nervous system, contributing to the pathogenesis of the disease. Blocking of VLA4 with a monoclonal antibody has been reported to lead to a reduction of new lesions in Multiple Sclerosis patients. Drugs which block or inhibit VLA4 are also thought to have potential application in other inflammatory diseases, including asthma, crohn's disease and rheumatoid arthritis.
In August 2003, Antisense Therapeutics commenced Phase I human clinical trials of ATL1102 at the Charterhouse Clinical Research Unit of the Ravenscourt Park Hospital. Fifty-four healthy volunteers participated in the double-blind, dose-escalation, placebo-controlled, randomized study. Antisense Therapeutics announced final results from these trials in June 2004. Based on the study’s results, 6mg/kg/week of ATL1102 appeared well tolerated and was selected as the proposed dose for Phase II development. In December 2004, the company announced the initiation of a Phase IIa trial of ATL1102 in patients with Multiple Sclerosis. In this multi-center, randomized, double-blinded, placebo-controlled clinical trial, patients with relapsing-remitting MS were to receive ATL1102 or placebo over eight weeks.
On 28 February 2005, Biogen Idec and Elan Corporation announced that they had voluntarily suspended marketing of their MS treatment, Tysabri® from the U.S. market and stopped dosing in all ongoing clinical trials. This decision was based on 2 reported cases of progressive multifocal leukoencephalopathy (PML), a rare and frequently fatal, demyelinating disease of the central nervous system, in patients who received Tysabri®. Subsequently, as a result of Biogen’s and Elan’s ongoing safety evaluation of Tysabri®, a previously diagnosed case of malignant astrocytoma was re-assessed as PML in a patient in an open label Crohn’s disease clinical trial.
On 10 March, 2005, Antisense Therapeutics announced that in light of the safety issues associated with the multiple sclerosis drug Tysabri®, it had voluntarily halted its Phase IIa trial of ATL1102 in MS patients and would convene an advisory group of relevant experts to consider the potential development paths for ATL1102 in this disease, including the possible restart of the Phase lla program. While ATL1102 is a different drug to Tysabri® and works by a different mechanism (antisense), the relevance of the Tysabri® issue to Antisense Therapeutics is that ATL1102 is designed to target the same immune system protein (VLA-4) as Tysabri®. On 31 August 2005 the Company was pleased to announce that it had accepted the recommendations of the MAB to continue the development of ATL1102 for MS and to restart the Phase IIa trial with additional safety monitoring of patients.
In January 2006 dosing commenced in the Phase IIa clinical trial of ATL1102 in patients with relapsing remitting multiple sclerosis (MS).
The study, a multi-centre, randomized, double-blinded, placebo-controlled clinical trial in approximately 80 patients with relapsing-remitting MS, is being conducted at 9 clinical trial sites across Germany.The trial will assess the activity and safety of the drug in MS patients.
http://www.antisense.com.au/_home.asp
ATL1102 for Multiple Sclerosis
ATL1102 is a second generation antisense inhibitor targeting VLA4, an immune cell molecule. ATL1102 was acquired by Antisense Therapeutics from Isis Pharmaceuticals as part of their collaborative agreement.
VLA4 is a receptor on the surface of lymphocytes (a particular class of immune cells) which is important in immune cell adhesion to blood vessel walls and subsequent migration of lymphocytes into tissue - a key event in inflammatory diseases.
With Multiple Sclerosis, excessive amounts of VLA4 are believed to mediate the inappropriate migration of lymphocytes into the central nervous system, contributing to the pathogenesis of the disease. Blocking of VLA4 with a monoclonal antibody has been reported to lead to a reduction of new lesions in Multiple Sclerosis patients. Drugs which block or inhibit VLA4 are also thought to have potential application in other inflammatory diseases, including asthma, crohn's disease and rheumatoid arthritis.
In August 2003, Antisense Therapeutics commenced Phase I human clinical trials of ATL1102 at the Charterhouse Clinical Research Unit of the Ravenscourt Park Hospital. Fifty-four healthy volunteers participated in the double-blind, dose-escalation, placebo-controlled, randomized study. Antisense Therapeutics announced final results from these trials in June 2004. Based on the study’s results, 6mg/kg/week of ATL1102 appeared well tolerated and was selected as the proposed dose for Phase II development. In December 2004, the company announced the initiation of a Phase IIa trial of ATL1102 in patients with Multiple Sclerosis. In this multi-center, randomized, double-blinded, placebo-controlled clinical trial, patients with relapsing-remitting MS were to receive ATL1102 or placebo over eight weeks.
On 28 February 2005, Biogen Idec and Elan Corporation announced that they had voluntarily suspended marketing of their MS treatment, Tysabri® from the U.S. market and stopped dosing in all ongoing clinical trials. This decision was based on 2 reported cases of progressive multifocal leukoencephalopathy (PML), a rare and frequently fatal, demyelinating disease of the central nervous system, in patients who received Tysabri®. Subsequently, as a result of Biogen’s and Elan’s ongoing safety evaluation of Tysabri®, a previously diagnosed case of malignant astrocytoma was re-assessed as PML in a patient in an open label Crohn’s disease clinical trial.
On 10 March, 2005, Antisense Therapeutics announced that in light of the safety issues associated with the multiple sclerosis drug Tysabri®, it had voluntarily halted its Phase IIa trial of ATL1102 in MS patients and would convene an advisory group of relevant experts to consider the potential development paths for ATL1102 in this disease, including the possible restart of the Phase lla program. While ATL1102 is a different drug to Tysabri® and works by a different mechanism (antisense), the relevance of the Tysabri® issue to Antisense Therapeutics is that ATL1102 is designed to target the same immune system protein (VLA-4) as Tysabri®. On 31 August 2005 the Company was pleased to announce that it had accepted the recommendations of the MAB to continue the development of ATL1102 for MS and to restart the Phase IIa trial with additional safety monitoring of patients.
In January 2006 dosing commenced in the Phase IIa clinical trial of ATL1102 in patients with relapsing remitting multiple sclerosis (MS).
The study, a multi-centre, randomized, double-blinded, placebo-controlled clinical trial in approximately 80 patients with relapsing-remitting MS, is being conducted at 9 clinical trial sites across Germany.The trial will assess the activity and safety of the drug in MS patients.