18/10/2007 - 11:39

Eastland wins approval for anti-malarial testing in Malaysia

18/10/2007 - 11:39

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West Perth-based Eastland Medical Systems Ltd has secured approval to commence the final stage of the single dose Phase 1 clinical testing of its new anti-malaria treatment in Malaysia.

West Perth-based Eastland Medical Systems Ltd has secured approval to commence the final stage of the single dose Phase 1 clinical testing of its new anti-malaria treatment in Malaysia.

The Malaysian clinical trial is expected to be completed by the end of November this year.

 

 

The full text of a company announcement is pasted below

Australian based Eastland Medical Systems Ltd (ASX: EMS) today announced the company is on-track to commence commercialisation of its new anti-malaria treatment during the first half of 2008, following approval to commence the final stage of the single dose Phase 1 clinical testing in Malaysia.

This single centre trial aims to measure the safety of the drug and compare the effectiveness of ArTiMistTM with the tablet form using the same compound.

Single dose clinical trial of ArTiMistTM in Malaysia and the multi dose clinical trial in South Africa are designed to confirm the safety of the new administration method and is seen by the company as a key milestone in bringing the product to market.

The Malaysia trial will be completed by the end of November 2007 and the clinical trial in Africa will be completed by early 2008.

As the tablet form of the drug already has toxicity approval, ArTiMistTM will move to Phase 3 clinical trials following the completion of both Phase 1 clinical trials. Phase 3 is the final stage in the clinical protocol for ArTiMistTM.

Early this year, the Eastland® Group secured the rights to distribute the new anti-malaria treatment ArTiMistTM - which uses a new method to administer the treatment - throughout Sub-Sahara, Asia, India and the Pacific Islands. The manufacture of ArTiMistTM has now been centralised in Germany for the Group.

This unique treatment uses a proven formula that is presently only available in tablet form, which - through the new method of administration - offers significant advantages over current treatments. Using ArTiMistTM the malaria parasite is attacked at greater speed than the conventional tablet form and importantly provides a significantly more effective treatment in children two years of age and under.

Eastland® CEO Dermot Patterson said the commencement of the Phase 1 clinical trials was a significant milestone in the development and introduction of the new anti-malaria treatment.

"The clinical trials are a stringent but important process requiring approval from the government of the country in which the trials are taking place and from international ethics committees before proceeding to this stage".

"Eastland® is confident that the results of the clinical trials will be positive, as the drug is based on an existing treatment.

"We are confident that this highly effective anti-malaria treatment will play a major role in addressing the epidemic of malaria around the world in the very near future."

Eastland® is also pursuing the introduction of the ClipOnTM (a safe needle system) as a compliant safe blood-drawing device as part of the blood testing process which forms part of the Malaria treatment.

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