QLT delays PhI Ia Atrigel study after AE reports

Canadian drugmaker QLT says that it will delay the initiation of a Phase IIa trial of Atrigel-delivered octreotide, its drug candidate for acromegaly. The decision was made in cooperation with the US Food and Drug Administration, after adverse events that occurred in an ongoing primate toxicology study designed to support repeated injections in patients.

The Phase IIa 16-patient study in acromegaly was expected to commence in the third quarter of the year with preliminary data expected in March 2007. However, the FDA has required the Vancouver-based firm to submit the final data from the ongoing toxicology study prior to initiating the clinical program. QLT expects to submit the complete results by the end of the year, noting that it will save $1.0 million on its 2006 R&D budget as a result of the delay.