The fallout from Tysabri's pullout has not stopped at Elan and BiogenIdec, but to all companies developing drugs that have similar methods of action as Tysabri. With that in mind, it is not surprising to report that Antisense's ATL1102 investigational compound, which targets exactly the same immune system protein as Tysabri (VLA-4), has now voluntarily suspended its phase II trial.
"Although Antisense Therapeutics and the trial investigators are confident that the current ATL1102 Phase 2a trial is safe, in light of the recently announced safety issues associated with Tysabri®, the Company has decided to halt the current trial and to convene an advisory group to consider the potential development paths for ATL1102 which may include restarting a Phase 2 trial program."
For those keeping score, that's Tysabri, Aimspro, and ATL1102 all stopped in a matter of weeks... Yes, we're still waiting for the good news that MUST be around the corner...
Click "read more" for the full press release...
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Full Press Release
Antisense Therapeutics Halts ATL1102 Phase 2a MS Trial
Company Plans to Convene Advisory Group to Consider Development Options
VICTORIA, Australia, March 10, 2005 - Although Antisense Therapeutics and the trial investigators are confident that the current ATL1102 Phase 2a trial is safe, in light of the recently announced safety issues associated with Tysabri®, the Company has decided to halt the current trial and to convene an advisory group to consider the potential development paths for ATL1102 which may include restarting a Phase 2 trial program.
On March 1, 2005 Antisense Therapeutics advised its shareholders of the decision by Biogen Idec and Elan Corporation to voluntarily suspend the marketing of their multiple sclerosis (MS) drug Tysabri® (antibody to VLA-4) based on reports of two cases of a serious (fatal) disease that occurred following treatment with Tysabri® in combination with Avonex® (Interferon beta-1a).
While Antisense Therapeutics’ product is different from Tysabri® and is being trialed as a single agent, not in combination with other drugs, 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®. In assessing the impact of these events on the ongoing ATL1102 trial, the Company has been in consultation with its trial investigators and other appropriate advisors.
The Company will be reviewing its overall product development strategy which includes the prospect of advancing its product pipeline - ATL1103 for growth and sight disorders and ATL1102 as an inhaled asthma treatment.
The Company would also like to take this opportunity to advise its shareholders that its lead psoriasis project, ATL1101, continues on track having commenced dosing of patients in the proof of concept clinical trial underway at Royal Adelaide Hospital.
About Antisense Therapeutics Limited
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. Its two most advanced projects target Multiple Sclerosis (ATL1102), and Psoriasis (ATL1101).
ANP plans to commercialise its pipeline via licensing/collaboration agreements with major biotechnology and pharmaceutical companies.
ANP’s major shareholders include Circadian Technologies Limited, Isis Pharmaceuticals Inc and Queensland Investment Corporation.
Contact Information: Website: www.antisense.com.au
Managing Director – Mark Diamond +61 3 9827 8999
Company Secretary – Natalie Korchev +61 3 9827 8999
