Ph IIa fosfluridine trial completes recruitment

Heidelberg Pharma, a privately-held German drug-development firm, has completed patient recruitment for a randomized placebo-controlled Phase IIa efficacy and safety trial of orally-administered fosfluridine tidoxil in actinic keratosis.

In the first part of the study, the results demonstrated that fosfluridine patients showed dose-related response rates up to 75% in terms of clearance or almost complete clearance of skin lesions. There were no responders in the placebo group. Based on this initial data the protocol was modified so that, in the second part of the study, a total of 41 patients were to be treated with either placebo or 150mg of fosfluridine with a post-treatment observation period extended from one to four months. The recruitment of patients for this part of the study has now been completed and final results are expected in May.