Phase I study of oral drug for RPE65 LCA

QLT announces the initiation of a Phase I trial of its synthetic retinoid product VANCOUVER, Oct. 9 /CNW/ - QLT Inc. (NASDAQ: QLTI; TSX: QLT) announced today that it has initiated a Phase I safety study in healthy adults of QLT091001, an orally administered synthetic retinoid replacement therapy for 11-cis-retinal, which is a key biochemical component of the visual retinoid cycle. The drug is being developed for the potential treatment of Leber's Congenital Amourosis (LCA), an inherited progressive retinal degenerative disease that leads to retinal dysfunction and visual impairment beginning at birth.The Phase I study is an open-label, single center, ascending dose trial that will determine the safety and tolerance of multiple administrations of the synthetic retinoid drug in approximately 18 healthy adult volunteers.Participants will be enrolled in up to 6 cohorts of increasing doses."We believe our retinoid synthetic drug program is a very interesting opportunity as there are no currently available treatments for patients with LCA, which affects one in one-hundred thousand newborns world-wide," said Bob Butchofsky, President and Chief Executive Officer of QLT. "This program also supports the Company's new ocular focus and we look forward to reporting the Phase I data in the first half of 2009. We hope that our findings will support further clinical studies in this orphan indication."

About Synthetic Retinoid Drugs

Genetic diseases in the eye such as Leber's Congenital Amaurosis (LCA)and Retinitis Pigmentosa (RP) arise from gene mutations of enzymes or proteins required in the biochemistry of vision. QLT091001 is a replacement for 11-cis-retinal which is an essential component of the retinoid-rhodopsin cycle and visual function. Two different gene mutations (Retinal pigment epithelium protein 65 (RPE65) and lecithin-retinol acyltransferase (LRAT)) result in an inadequate production of 11-cis-retinal and occur in approximately 10% of patients with LCA and to a lesser extent in RP.The basis for using synthetic retinoids as replacement therapy for conditions where genetic defects result in deficiency of 11-cis-retinal is founded on experiments in mouse genetic models. These experiments used mice that have mutations in either the RPE65 or LRAT genes, the same as those associated with LCA in humans. Both mouse models have clinical features of the human disease. The biological activity of the synthetic retinoid was monitored by measuring the level of pigment-related compounds in the eye. Retinal function was also assessed by detecting electroretinograms (ERGs), electrical nerve signals from the retina. Oral administration of QLT091001 showedevidence of having corrected the biochemical defect in the retinoid cycle in light-sensing cells (rods) and appeared to restore ERG responses to light in both models of LCA.

About QLT

QLT Inc. is a global biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies. Our research and development efforts are focused on pharmaceutical products in the fields of ophthalmology and dermatology. In addition, we utilize three unique technology platforms, photodynamic therapy, Atrigel(R) and punctal plugs with drugs, to create products such as Visudyne(R) and Eligard(R) and future product opportunities. For more information, visit our web site at
www.qltinc.com.

In April of 2006, QLT entered into an exclusive worldwide co-development and licensing agreement with Retinagenix, LLC, to develop active synthetic retinoid products for the treatment of degenerative retinal diseases.Pre-clinical studies have demonstrated that orally administered synthetic retinoid drugs cause long-lasting restoration of retinal function. Under the terms of the agreement, QLT is responsible to develop and commercialize the products for use in ocular and all other human diseases.

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