Singapore, Feb 18, 2008: Giaconda Limited, an Australian life sciences company involved in developing and commercializing innovative and cost effective medical therapies in the field of gastroenterology based at Sydney announced the results of a study investigating the predicted effectiveness and safety of Myoconda for the treatment of Mycobacterium avium paratuberculosis (MAP) infection in Crohn’s Disease.  The components, Rifabutin, Clarithromycin and Clofazimine, are all approved for use in humans as separate agents.

 

This pilot pharmacokinetic study was designed to optimize the formulation of Myoconda by combining the three components into a single capsule following discussions with the US Food and Drug Administration (FDA). The study was included as part of the IND (Investigational New Drug Application) that was approved by the FDA last year.

 

The study design used 24 normal, healthy, non-smoking male and female subjects under a randomized, open-label, single-dose, 1-way 2-arm, parallel design.  There were no significant or serious adverse events reported in either arm.

 

The significant finding was that in the ‘all-in-one’ formulation the blood concentrations of Rifabutin and Clarithromycin achieved were more optimal, for both components causing no significant adverse effects with potentially increased efficacy. Previous studies indicated that concomitant use of these two agents can elevate the levels of Rifabutin in the blood, increasing the potential for side effects and reduce the levels of Clarithromycin, thus potentially reducing the efficacy of this important active ingredient.

 

The new formulation has improved both the pharmacokinetic availability of both ingredients and reduced the side effect potential, providing a novel and significant improvement on previous formulations. A patent application has been filed by Giaconda to protect the novel formulation technique.

 

“This study is an important step in the development of a solid safety and efficacy profile for Myoconda in the treatment of MAP infection in Crohn’s Disease, and reflects the resourceful and innovative support we have received from our formulation consultants,” said Mr Patrick McLean, CEO of Giaconda.

 

Mr McLean further said, “The metabolic benefits of the new formulation add value to an already promising product. This result bolsters Myoconda’s already impressive record in the clinic, which, with the new formulation patent, will help support our ongoing negotiations with potential distribution and marketing partners and in our fundraising efforts.”