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QLT Inc. has released results from its phase Ia trial of QLT091001, a new drug QLT is developing for the potential treatment of Leber's congential amaurosis.
Vancouver, British Columbia
―QLT Inc. has released results from its phase Ia trial of QLT091001, a new drug QLT is developing for the potential treatment of Leber’s congential amaurosis (LCA).
Conditions such as LCA and retinitis pigmentosa are caused by gene mutations of enzymes or proteins that are required in the biochemistry of vision. QLT091001 is a replacment for 11-cis-retinal, an essential component of the retinoid-rhodopsin cycle and visual function.
For this open-label, single-center, ascending-dose trial of QLT091001, 20 healthy adults were enrolled in six cohorts of increasing doses. No serious adverse events occurred, and mild adverse events-including facial flushing and headache-occurred in patients treated with the highest dose. All adverse events were transient in nature and resolved during the treatment period.
“We are pleased to report that QLT091001 demonstrated an adequate safety profile in healthy adults,” said Bob Butchofsky, president and chief executive officer of QLT. “Our next step is to speak with the Canadian health authorities to determine future clinical development plans. We expect to initiate a phase Ib trial in the second half of 2009 in pediatric patients with LCA, a disease which affects one in 100,000 newborns worldwide for which there are currently no available treatments.”