HalcyGen Begins Second Study Of Anti-Fungal Drug - Anti-Fungal Drug Moves Into Second Study Before Phase III Trials

Main Category: Dermatology
Also Included In: Clinical Trials / Drug Trials
Article Date: 08 Aug 2007 - 1:00 PDT

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HalcyGen Pharmaceuticals Limited (ASX: HGN) has begun its second clinical study of its lead product, anti-fungal drug SUBA-Itraconazole. The trial will optimise the capsule formulation that the company aims to evaluate in phase III trials and file for registration next year.

This trial follows recently reported successful first round pharmacokinetic results in patients receiving SUBA-Itraconazole.

HalcyGen's new formulation of Itraconazole/Sporanox* is designed for improved absorption and more reliable blood levels of the anti-fungal agent. The drug and manufacturing technology is licensed from Mayne Pharma International.

Dr Roger Aston, HalcyGen's CEO said, "we are on track with this programme. We have now completed the dosing of patients in the planned second pharmacokinetic study and in coming weeks we will analyse and report to the market on drug levels in the blood."

The study in 12 patients was a single-dose, randomised, open-label, four treatment, four-way crossover study aimed at determining the optimal dose of the SUBA-Itraconazole formulation. The analysis will be used for the design of a pivotal registration study in late 2007/early 2008.

*Sporanox is owned by Janssen Pharmaceuticals part of the J&J Group

About HalcyGen

HalcyGen has been founded to bridge the gap between mainline pharmaceutical companies and high volume generics companies through the development and licensing of new improved proprietary generic formulations known as "Super Generics" or "High Functionality Generics".

The basis of HalcyGen's strategy is a strategic licensing partnership with global pharmaceutical company Mayne Pharma. HalcyGen will initially develop and market two anti-infective products with Mayne Pharma . Subject to performance and meeting other criteria, the Company has the opportunity to develop further products with Mayne Pharma.

http://www.halcygen.com