phase iii trials complete - data awaited

Field trials for the following Phase III trial are complete and the data from the trial results will be completed in Q4, 2012.

"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.”

What I find particularly interesting about this trial is that ArTiMist is being trialled "for superiority" over the current standard of care (IV quinine).

The previous Phase IIa trials found that:

"In summary, there were no clinical or statistically relevant differences between the two treatments in any of the study efficacy parameters which is in itself a remarkable outcome. There were also no safety related withdrawals from the study and no adverse events
related to ArTiMist™.

Although this study was not designed to investigate the
pharmacokinetic (PK)/ pharmacodynamic (PD) relationships, it was observed that ArTiMist™ was rapidly absorbed reaching high plasma concentrations, which in turn correlates well with the rate of parasite reduction and clinical response by those patients that received
ArTiMist™."

If it prevails that ArTimist is not only "as good as" but "is superior" to the current standard of care then that will also benefit trade-sale price.

bluebush