QLT has announced today that it will delay the initiation of its Phase IIa Atrigel/octreotide program in acromegaly patients. This decision was made, in cooperation with the FDA, following adverse event findings that occurred in an ongoing primate toxicology study designed to support repeated injections in patients.
The 16-patient study was expected to begin in the third quarter of 2006, with preliminary data expected in March 2007. However, the FDA has required that QLT submit the final data from the ongoing toxicology study prior to initiating the clinical program. 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 enrollment can begin in the study.