article from biotechnologynews.net

Eastland to launch Phase 3 malaria trial

Nick Evans
Thursday, 12 November 2009

EASTLAND Medical Systems has finally launched the Phase 3 trial of its ArTiMist malaria treatment, more than 12 months after its initial projected launch.



In its 2007-08 annual report the company said it expected to begin the trial by the end of last year, but the drawn-out capital raising process saw the company struggle to raise the necessary money to get the trial off the ground.

But it’s finally underway, with Eastland announcing yesterday its project consultant, ProtoPharma, has been given the green light by a Rwandan ethics committee to launch recruitment in the trial in that country.

Eastland says the Phase 3 trial will likely recruit 50-100 children with severe or complicated falciparum malaria, or uncomplicated falciparum malaria with gastrointestinal complications.

The open label study will compare Eastland’s under-the-tongue treatment, ArTiMist, with intravenous quinine.

Eastland chief executive Dermot Patterson told BTN the company expected recruitment to be rapid, as the region was approaching peak malaria season.

He said the company expected to be able to announce initial results from the trial either by the end of December or early in the new year.

Patterson said positive results from the trial should see the company able to lodge a marketing application for ArTiMist in Rwanda, and to an important World Health Organisation pre-qualification program for essential medicines, by the end of the first half of next year at the latest.

Background

Eastland’s ArTiMist malaria treatment is in development for the treatment of infants and children, using a multiple-dose spray device for under-the-tongue delivery of a formulation containing existing malaria treatment artemether.

The company said the use of the sublingual mouth spray offered an easier and more hygienic method of administering the drug.

Delivering the drug under the tongue also offers the potential of a better uptake of the drug in many regions, as patients suffering from malnutrition often have difficulty in processing artemether in tablet form.

ArTiMist cleared Phase 1 trials last year.