Eastland Medical Systems' phase 3 malaria clinical trial gains momentum
Eastland Medical Systems (ASX: EMS) has achieved two significant milestones in a phase three African trial of its malaria treatment, ArTiMist™, in children with the completion of patient enrolment as well as dosing.
ArTiMist™ is administered sub-lingually or under the tongue and enters the bloodstream where the parasite lives.
The treatment has been shown to be especially effective in children and young infants who are experiencing malaria-related and gastro-intestinal problems and cannot tolerate tablet treatments.
The current trial is covering ArTiMist™ versus intravenous quinine in children with severe or complicated falciparum malaria, or uncomplicated falciparum malaria with gastrointestinal complications.
The patients will be monitored for 28 days post dosing, following which Eastland will complete the pharmacodynamics studies, biochemistry and parasitology, and other evaluations of the patient data – due for completion in the December quarter.
This coincides with the manufacturing of the Registration batches of ArTiMist™ in Canada which is progressing on time and budget.
Eastland is re-evaluating the total market for ArTiMist™ based on a scientific review published in the peer reviewed British medical journal The Lancet earlier this year.
The study shows that malaria in 2010 was the cause of death for 1.2 million individuals, including 714,000 deaths in children younger than five years and 524,000 in individuals aged five years or older.
This is almost twice the number (655,000) that the World Health Organization estimated for the same period.
Importantly, the understanding of this new data will result in a potential significant increase in the market size for ArTiMist™.
Phase one clinical trials have been completed that show there were no adverse effects and ArTiMist™ was well tolerated.
Around 40% of the world’s population, mostly those living in the world’s poorest countries, are at risk of malaria.
Every year more than 500 million people become severely ill with the disease. Most cases and deaths are in sub-Saharan Africa; however Asia, Latin America, the Middle East and parts of Europe are also affected.
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