Tuesday 13th April 2010, Melbourne Australia: HalcyGen Pharmaceuticals Limited (ASX: HGN) is pleased to announce that it has recruited and began treatment of the last patient in its US-based Phase II study to examine the safety and efficacy of its SUBAâ-Itraconazole. The study is a randomized, double blind, multiple-site, placebo-controlled study, comparing the efficacy and safety of SUBAâ-Itraconazole capsules compared to Sporanox®* (itraconazole) capsules in the treatment of onychomycosis of the toenail.
On completion of the daily treatment regimen (90 days) for the last patient, data from the trial will be processed with final results being available in the last quarter 2010. Halcygen initiated this trial in the US under the guidance of the US FDA as part of its US-based registration programme. It is expected that the data from this trial will also be of value in the EU registration programme currently in process. HalcyGen recently announced (2nd March 2010) the preliminary outcome of its EU-based pharmacokinetic** study aimed towards EU registration.
HalcyGen’s CEO Dr Roger Aston said, “Efficacy-Safety studies are substantial clinical programmes (175 patients) – this, our first efficacy study, was conducted through six dermatology clinics in the USA” “The study should provide a good indication on how SUBAâ-Itraconazole performs against the market leader (Sporanoxâ)”.”Halcygen will meet with the FDA after the final results are available to see what further clinical studies maybe required for filing for registration in the US”.
*Sporanoxâ is the market leading form of itraconazole and is owned by Janssen Pharmaceutical Products LP—part of the Johnson & Johnson Group.
**Pharmacokinetic Studies: Clinical pharmacokinetic studies are performed to examine the absorption, distribution, metabolism and excretion of a drug under investigation (investigational drug and approved drug) in healthy volunteers and/or patients. Pivotal pharmacokinetic studies are studies that form part of the registration dossier for a new drug application (NDA in USA or MAA in EU).
HalcyGen: Dr Roger Aston 0402 762 204
Craig Bottomley 0414 328 055