Approval to restart Phase IIa trial in MS patients
Approval to restart Phase IIa trial in MS patients
Antisense Therapeutics (AUSTRALIA)
January 12, 2006
http://www.biotech-intelligence.com/html/html/a9ef1ab7fa5bf410d3bcc6061bbfcb63.html
Antisense Therapeutics is pleased to report that the Ethics Committee of the University of Essen in Germany has approved the company's application to restart the Phase IIa trial of its antisense compound, ATL1102, for patients with relapsing remitting multiple sclerosis. The University of Essen is the primary trial site for the Phase IIa clinical trial. The Company now has the requisite approval and regulatory documentation in place to restart the Phase IIa trial at this centre.
Patient enrolment and dosing are expected to commence at the University of Essen in February/March 2006. The other 8 trial centres will, in turn, be initiated in the coming months. The treatment and patient monitoring stages of the 80-patient trial are expected to be completed by the end of 2006 assuming patient recruitment proceeds at the anticipated rate.
The Ethics Committee approval follows the recommendation of a specially convened Medical Advisory Board of independent medical experts to continue the drug's development.
Antisense CEO Mark Diamond said "We are pleased to have received this approval to progress the further development of our MS drug, which as stated by the Medical Advisory Board, appears to have significant potential as a therapeutic agent in relapsing-remitting MS."
He added that "The Company has been focussed on restarting the Phase IIa trial for ATL1102 in MS patients in an endeavour to restore the shareholder value that has been created over the last 4 years through successful preclinical animal studies and the completion of a Phase 1 clinical trial in humans." ATL1102 is a second-generation antisense inhibitor of an immune system protein called VLA-4 and is designed to block the synthesis of VLA-4 which is known to play a part in both the onset and progression of multiple sclerosis. ATL1102's mechanism of action in blocking VLA-4 is different to other drugs in development that target VLA-4 (including the monoclonal antibody Tysabri®) and represents a novel therapeutic approach to the treatment of MS.
Multiple sclerosis is a life long chronic disease of the central nervous system which is believed to affect as many as 2.5 million people worldwide. While existing drug sales for this disease were greater than US$4 billion in 2004 there remains a high demand for more effective and better tolerated treatments. The Phase IIa trial of ATL1102 will assess the activity and safety of the drug in MS patients.
Additional information:
1. Background re development of ATL1102
2. Study design
3. Update on MS treatment Tysabri®
4. About ATL1102 for multiple sclerosis
5. About Antisense Therapeutics Limited
1. Background re development of ATL1102
After successful results in preclinical animal studies and a Phase I trial in humans, Phase II clinical trials on ATL1102 commenced in December 2004.
This trial was voluntarily halted by Antisense Therapeutics in March 2005 in light of safety issues associated with Biogen Idec and Elan Corporation's multiple sclerosis drug Tysabri® and in May 2005 the company established and convened an independent Medical Advisory Board (MAB) to consider the potential development paths for ATL1102. Although ATL1102, an antisense inhibitor, is a different drug from Tysabri®, a monoclonal antibody, and thereby works by a different mechanism, both compounds target the same immune system protein (VLA-4).
In August 2005, the MAB unanimously recommended that the company continue the development of ATL1102 in MS and that the Phase IIa trial be restarted with the addition of certain safety parameters to address the potential safety issues related to JC viral activation and the appearance of progressive multifocal leukoencephalopathy (PML) reported in the Tysabri® trials. The directors of Antisense Therapeutics accepted and agreed with this recommendation.
Apart from the addition of the suggested safety parameters, the trial design and clinical assessment objectives remain the same for the Phase IIa trial as reported by the company when this trial was first initiated in December 2004 with the exception that anticipated patient numbers have increased from 60 to 80 as reported in February 2005.
2. Phase IIa study design summary
This study is a multi-centre, randomized, double-blinded, placebo-controlled clinical trial, in approximately 80 patients with relapsing-remitting MS. Patients 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.
The trial will be conducted at 9 sites across Germany, which includes the primary trial centre, for which Ethics Committee approval has been received. Applications to initiate these other sites have been filed with the Institutional Review Boards and Ethics Committees of the respective participating centres. Enrolment and dosing will commence at each site as the requisite approvals are received.
3. Update on Tysabri®
Since announcing that they had voluntarily suspended Tysabri from the U.S. market and all ongoing clinical trials based on reports of PML, Biogen Idec (Biogen) and Elan Corporation (Elan) have reported that they have "completed a comprehensive safety evaluation of more than 3,000 Tysabri patients in collaboration with leading experts in PML and neurology. The results of the safety evaluation yielded no new confirmed cases of PML beyond the three previously reported" (17 November 2005 Biogen news release).
On November 17, 2005 Biogen and Elan announced that "the supplemental Biologics License Application (sBLA) for Tysabri® (natalizumab) for the treatment of multiple sclerosis has been accepted and designated for Priority Review by the U.S. Food and Drug Administration (FDA). The FDA grants Priority Review status to products that are considered to be potentially significant therapeutic advancements over existing therapies that address an unmet medical need. Based on the FDA's designation of Priority Review for Tysabri® in MS, the companies anticipate action by the Agency approximately six months from the submission date [September 26, 2005], rather than 10 months for a standard review."
4. About ATL1102 for MS
ATL1102 is a second generation antisense inhibitor of CD49d, a subunit of VLA-4 (Very Late Antigen-4), and is currently in development as a treatment for MS. In inflammation, white blood cells (leukocytes) move out of the bloodstream into the inflamed tissue, for example, the CNS in MS, and the lung airways in asthma. The inhibition of VLA-4 may prevent white blood cells from entering sites of inflammation, thereby halting progression of the disease. Antisense inhibition of VLA-4 has demonstrated positive effects in a number of animal models of inflammatory disease including MS. While the current market for MS drugs is large (in excess of US$4 Billion per annum) there continues to be a high demand for improved MS therapies. The directors of Antisense Therapeutics believe ATL1102 could have significant commercial potential should clinical investigations show the compound to be suitably safe and effective.
5. About Antisense Therapeutics Limited (ASX:ANP)
Antisense Therapeutics Limited (ASX: ANP) is an Australian publicly listed biopharmaceutical drug discovery and development company. ANP's mission is to create, develop and commercialise novel antisense pharmaceuticals for large unmet markets. The company's product pipeline includes ATL1102 for Multiple Sclerosis, and ATL1101 for Psoriasis, both of which have advanced to the stage of human clinical trials and ATL1103, a potential treatment for growth (acromegaly) and sight disorders (diabetic retinopathy and wet-are related macular degeneration), which is in pre-clinical development. ANP's major shareholders include Circadian Technologies Limited (ASX:CIR) and Isis Pharmaceuticals Inc.(NASDAQ:ISIS)
Contact Information: Website: www.antisense.com.au
Managing Director – Mark Diamond +61 3 9827 8999
Company Secretary – Natalie Korchev +61 3 9827 8999
Media – Market Connect (Simon Watkin) +61 3 9646 5900
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Antisense Therapeutics (AUSTRALIA)
January 12, 2006
http://www.biotech-intelligence.com/html/html/a9ef1ab7fa5bf410d3bcc6061bbfcb63.html
Antisense Therapeutics is pleased to report that the Ethics Committee of the University of Essen in Germany has approved the company's application to restart the Phase IIa trial of its antisense compound, ATL1102, for patients with relapsing remitting multiple sclerosis. The University of Essen is the primary trial site for the Phase IIa clinical trial. The Company now has the requisite approval and regulatory documentation in place to restart the Phase IIa trial at this centre.
Patient enrolment and dosing are expected to commence at the University of Essen in February/March 2006. The other 8 trial centres will, in turn, be initiated in the coming months. The treatment and patient monitoring stages of the 80-patient trial are expected to be completed by the end of 2006 assuming patient recruitment proceeds at the anticipated rate.
The Ethics Committee approval follows the recommendation of a specially convened Medical Advisory Board of independent medical experts to continue the drug's development.
Antisense CEO Mark Diamond said "We are pleased to have received this approval to progress the further development of our MS drug, which as stated by the Medical Advisory Board, appears to have significant potential as a therapeutic agent in relapsing-remitting MS."
He added that "The Company has been focussed on restarting the Phase IIa trial for ATL1102 in MS patients in an endeavour to restore the shareholder value that has been created over the last 4 years through successful preclinical animal studies and the completion of a Phase 1 clinical trial in humans." ATL1102 is a second-generation antisense inhibitor of an immune system protein called VLA-4 and is designed to block the synthesis of VLA-4 which is known to play a part in both the onset and progression of multiple sclerosis. ATL1102's mechanism of action in blocking VLA-4 is different to other drugs in development that target VLA-4 (including the monoclonal antibody Tysabri®) and represents a novel therapeutic approach to the treatment of MS.
Multiple sclerosis is a life long chronic disease of the central nervous system which is believed to affect as many as 2.5 million people worldwide. While existing drug sales for this disease were greater than US$4 billion in 2004 there remains a high demand for more effective and better tolerated treatments. The Phase IIa trial of ATL1102 will assess the activity and safety of the drug in MS patients.
Additional information:
1. Background re development of ATL1102
2. Study design
3. Update on MS treatment Tysabri®
4. About ATL1102 for multiple sclerosis
5. About Antisense Therapeutics Limited
1. Background re development of ATL1102
After successful results in preclinical animal studies and a Phase I trial in humans, Phase II clinical trials on ATL1102 commenced in December 2004.
This trial was voluntarily halted by Antisense Therapeutics in March 2005 in light of safety issues associated with Biogen Idec and Elan Corporation's multiple sclerosis drug Tysabri® and in May 2005 the company established and convened an independent Medical Advisory Board (MAB) to consider the potential development paths for ATL1102. Although ATL1102, an antisense inhibitor, is a different drug from Tysabri®, a monoclonal antibody, and thereby works by a different mechanism, both compounds target the same immune system protein (VLA-4).
In August 2005, the MAB unanimously recommended that the company continue the development of ATL1102 in MS and that the Phase IIa trial be restarted with the addition of certain safety parameters to address the potential safety issues related to JC viral activation and the appearance of progressive multifocal leukoencephalopathy (PML) reported in the Tysabri® trials. The directors of Antisense Therapeutics accepted and agreed with this recommendation.
Apart from the addition of the suggested safety parameters, the trial design and clinical assessment objectives remain the same for the Phase IIa trial as reported by the company when this trial was first initiated in December 2004 with the exception that anticipated patient numbers have increased from 60 to 80 as reported in February 2005.
2. Phase IIa study design summary
This study is a multi-centre, randomized, double-blinded, placebo-controlled clinical trial, in approximately 80 patients with relapsing-remitting MS. Patients 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.
The trial will be conducted at 9 sites across Germany, which includes the primary trial centre, for which Ethics Committee approval has been received. Applications to initiate these other sites have been filed with the Institutional Review Boards and Ethics Committees of the respective participating centres. Enrolment and dosing will commence at each site as the requisite approvals are received.
3. Update on Tysabri®
Since announcing that they had voluntarily suspended Tysabri from the U.S. market and all ongoing clinical trials based on reports of PML, Biogen Idec (Biogen) and Elan Corporation (Elan) have reported that they have "completed a comprehensive safety evaluation of more than 3,000 Tysabri patients in collaboration with leading experts in PML and neurology. The results of the safety evaluation yielded no new confirmed cases of PML beyond the three previously reported" (17 November 2005 Biogen news release).
On November 17, 2005 Biogen and Elan announced that "the supplemental Biologics License Application (sBLA) for Tysabri® (natalizumab) for the treatment of multiple sclerosis has been accepted and designated for Priority Review by the U.S. Food and Drug Administration (FDA). The FDA grants Priority Review status to products that are considered to be potentially significant therapeutic advancements over existing therapies that address an unmet medical need. Based on the FDA's designation of Priority Review for Tysabri® in MS, the companies anticipate action by the Agency approximately six months from the submission date [September 26, 2005], rather than 10 months for a standard review."
4. About ATL1102 for MS
ATL1102 is a second generation antisense inhibitor of CD49d, a subunit of VLA-4 (Very Late Antigen-4), and is currently in development as a treatment for MS. In inflammation, white blood cells (leukocytes) move out of the bloodstream into the inflamed tissue, for example, the CNS in MS, and the lung airways in asthma. The inhibition of VLA-4 may prevent white blood cells from entering sites of inflammation, thereby halting progression of the disease. Antisense inhibition of VLA-4 has demonstrated positive effects in a number of animal models of inflammatory disease including MS. While the current market for MS drugs is large (in excess of US$4 Billion per annum) there continues to be a high demand for improved MS therapies. The directors of Antisense Therapeutics believe ATL1102 could have significant commercial potential should clinical investigations show the compound to be suitably safe and effective.
5. About Antisense Therapeutics Limited (ASX:ANP)
Antisense Therapeutics Limited (ASX: ANP) is an Australian publicly listed biopharmaceutical drug discovery and development company. ANP's mission is to create, develop and commercialise novel antisense pharmaceuticals for large unmet markets. The company's product pipeline includes ATL1102 for Multiple Sclerosis, and ATL1101 for Psoriasis, both of which have advanced to the stage of human clinical trials and ATL1103, a potential treatment for growth (acromegaly) and sight disorders (diabetic retinopathy and wet-are related macular degeneration), which is in pre-clinical development. ANP's major shareholders include Circadian Technologies Limited (ASX:CIR) and Isis Pharmaceuticals Inc.(NASDAQ:ISIS)
Contact Information: Website: www.antisense.com.au
Managing Director – Mark Diamond +61 3 9827 8999
Company Secretary – Natalie Korchev +61 3 9827 8999
Media – Market Connect (Simon Watkin) +61 3 9646 5900
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