Development Plan

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Acea looks to Brisbane, Australia to conduct

"first in human" study.

Acea prepares for first in human clinical trials.

Acea has completed of host of animal studies on Corifungin setting the stage to take the drug into the clinic. Animal models, testing for both efficacy and for toxicity have been successfully conducted. They include (1) oral efficacy testing mice infected with Candida albicans, (2) completing a mouse model for vulvo candidiasis given orally, (3) testing mice with aspergillus, (4) testing mice treated IP against Naegleria fowleri (brain-eating amoeba), (5) testing immunocompromised mice against Candida infections, and (6) testing mice with Leishmania donovani.
Animal models have been completed testing for acute toxicity. The primary focus is nephrotoxicity which often occurs with patients who receive amphotericin B

The study of a 28-day rat model, given orally, showed very little toxicity even at doses as high as 250mg/kg. Acea also did a 28-day toxicity study administered intravenously with a comparison to amphotericin B. Again, Corifungin we well tolerated even at a dosing of two and half times that of amphotericin B.

Acea is currently exploring sites in Australia to conduct its first clinical trial.

The first in human study will be for an oral formulation of Corifungin. There is a strong need in the market for a more potent, oral antifungal drug.

Australia was selected as a possible site for clinical trial due to its robust clinical facilities, its history of successful trials, and for the attractive tax advantages when compared to other locations.

Acea's First Time in Human (FTIH) study protocol will be for oral administration. A standard Phase I study will be conducted, consistent with FDA guidelines, to gain a better understanding of how well the doses are tolerated and the corresponding pharacokinetic markers.

Following the Phase I, Acea will proceed into a very small Phase IIb study to test for effectiveness.