Eastland’s (EMS) Board is pleased to provide you with the following update from the African ART004 Clinical Trial titled, “A Phase III, randomized, open labelled, active controlled, multi-centre, superiority trial of ArTiMist™ versus intravenous quinine in children with severe or complicated falciparum malaria, or uncomplicated falciparum malaria with gastrointestinal complications.”
We have received confirmation that the recruitment of patients for the trial is complete and the trial is now fully enrolled. We can also confirm that patient dosing has also been completed. These are significant milestones in the clinical development program for ArTiMist™.
The patients will be monitored for 28 days post dosing. On completion of the monitoring we will complete the pharmacodynamics studies, biochemistry and parasitology and other evaluations of the patient data. These results will then be forwarded to the Biostatisticians for analysis and then to the Medical Writer for compilation into the final clinical report. It is anticipated that this should be completed during the 4th quarter of this year.
This timeframe fits in well with the manufacturing of the Registration batches of ArTiMist™ that is occurring in Canada. The manufacturing program is on time and budget and Eastland is pleased with the progress to-date.
Eastland is re-evaluating the total market for ArTiMist™ based on a scientific review published in the well-respected peer reviewed British Medical Journal “LANCET” earlier this year. The study was carried out by researchers from the University of Washington, Seattle, and the University of Queensland in Australia, and was funded by The Bill & Melinda Gates Foundation.
This study has looked at a large amount of data and used systematic methods to examine trends in malaria mortality over the past 30 years. It 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 Organisation (WHO) estimated for the same period. The understanding of this new data will result in a potential significant increase in the market size for ArTiMist™. The impact of this increase on the valuation of ArTiMist™ is still to be determined.