Antisense Therapeutics Limited ("ANP") is pleased to report that 24 acromegalic patients have been successfully enrolled and randomized to one of the two treatment regimens of dosing in the Phase II trial of ATL1103 for the growth disorder, acromegaly. This satisfies the necessary patient numbers proposed for the trial.
Following from the positive results achieved from the interim analysis of the serum Insulin-like Growth Factor-I (sIGF-I) data from the 8 patients who had completed the full 13 weeks of dosing in the trial, a further 8 (16 in total) have now completed dosing. Notably to date no patients dosed with ATL1103 have withdrawn from the study nor have there been any reports of serious adverse events identified as treatment related.
With patient enrollment now complete, ANP anticipates reporting the results of the statistical analysis of the sIGF-I data from all patients by mid 2014. Reducing sIGF-I levels is the primary marker of ATL1103 activity in this trial as acromegaly patients have elevated sIGF-I levels compared to the normal population, and reduction of sIGF-I to within a normal range in a significant proportion of patients is the goal in Phase III registration trials for acromegaly treatments.
Mark Diamond, Managing Director and CEO of Antisense Therapeutics said, "Completion of patient recruitment into a clinical trial is a major milestone and especially in the case of trials involving patients with a rare or orphan status disease such as acromegaly and so we are very pleased to report this significant achievement. We now look forward to completing the dosing in all patients and to the reporting of the results."
SOURCE Antisense Therapeutics Limited