Dec 15 2009
QLT Inc. (NASDAQ: QLTI; TSX: QLT) ("QLT" or the "Company") today announced that it has initiated enrollment in a Phase Ib trial of QLT091001 in pediatric patients with Leber Congenital Amaurosis (LCA), an inherited progressive retinal degenerative disease that leads to retinal dysfunction and visual impairment beginning at birth. QLT091001 is an orally administered synthetic retinoid replacement for 11-cis-retinal, which is a key biochemical component of the visual retinoid cycle.
The Phase Ib trial is an open-label, single center trial to evaluate the safety profile and effects on retinal function in 8 pediatric patients (aged 5 to 14 years) with LCA due to inherited deficiency of RPE65 or LRAT. Patients will receive daily doses of QLT091001 for 7 days at the Montreal Children's Hospital in Montreal, Canada under the trial's Principal Investigator, Dr. Robert Koenekoop. The trial will monitor for changes in several visual function parameters including the best-corrected visual acuity over the duration of the study.
"Given the encouraging nonclinical testing in animal models and the safety results from the Phase Ia healthy adult volunteer trial, we are very excited to move QLT091001 into Phase Ib testing," said Bob Butchofsky, President and Chief Executive Officer of QLT. "Children with LCA have few treatment options and we are hopeful that QLT will be able to advance this compound in clinical trials. We look forward to reporting data from this trial in the next few months."
SOURCE QLT Inc.