QLT Inc. delays the initiation of its phase IIa Atrigel/Octreotide programme in acromegaly patients. This decision was made, in cooperation with the US FDA, following adverse event findings 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 initiate in Q3 2006 with preliminary data expected in March 2007. However, the FDA had required QLT to submit the final data from the ongoing toxicology study prior to initiating the clinical programme. QLT expects to be able to submit the complete results of the toxicology study by the end of 2006. Following the FDA's review of the data the FDA will determine whether patient enrolment can begin in the phase IIa acromegaly study.
QLT expects that there will be savings of approximately $1 mn in the 2006 research and development budget associated with the delay of the clinical trial in acromegaly and will update any future potential impact after a thorough analysis of the octreotide programme.