Presentation on May 10, 2012 Will Highlight Data From Phase 1b Trial in Subjects With Retinitis Pigmentosa Due to RPE65 and LRAT Mutations
VANCOUVER, British Columbia, April 2, 2012 (GLOBE NEWSWIRE) -- QLT Inc. (Nasdaq:QLTI) (TSX:QLT) ("QLT" or the "Company") today announced that data from the Phase 1b trial of QLT091001 in subjects with Retinitis Pigmentosa (RP) due to RPE65 and LRAT mutations will be presented at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Fort Lauderdale, Florida.
Trial investigator, Artur V. Cideciyan , Ph.D., Research Professor of Ophthalmology, Scheie Eye Institute, University of Pennsylvania, will present a paper titled "Increased Vision within Days of Oral cis-retinoid (QLT091001) Treatment in Blindness due to Mutations in Retinal Pigment Epithelium-specific Protein 65kDa (RPE65) or Lecithin Retinol Acyltransferase (LRAT)" on Thursday, May 10 at 9:15 a.m. ET.
The Company will host a webcast conference call for investors, analysts and media to present and discuss the data on Thursday, May 10 at 11:30 a.m. ET. During the conference call, Dr. Cideciyan will present the RP study data. Professor Alan Bird , Emeritus Professor at London University, Honorary consultant, Moorfields Eye Hospital and Robert K. Koenekoop, M.D., Ph.D. from McGill University Health Centre in Montreal, will also be participating on the conference call. Those attending the call from QLT include Bob Butchofsky , President and Chief Executive Officer, and Suzanne Cadden , Senior Vice President, Development.
Other presentations of interest during ARVO include: Efficacy and Safety of a Novel Oral Retinoid in the Treatment of Childhood Blindness Due to RPE65 or LRAT Mutations – special interest group talk
Robert Koenekoop, M.D., Ph.D., McGill University Health Center in Montreal
Monday, May 07, 2012, between 12:00 p.m. and 1:30 p.m. ET
Update on QLT091001 in Subjects with Leber Congenital Amaurosis (LCA) due to LRAT or RPE65 mutations: Longer-term follow-up of subjects originally treated with 7-day therapy
Dr. Robert Koenekoop , M.D., Ph.D.,
McGill University Health Center in Montreal
Wednesday, May 09, 2012, 3:15 p.m. ET
A Phase 2 Study Evaluating Safety and Efficacy of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects with Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)
Dr. Damien Goldberg , MD, Wolstan & Goldberg Eye Associates, Torrance, CA
Wednesday, May 09, 2012, 1:45 p.m. ET
Webcast Conference call
QLT will hold a call for investors, analysts and media to discuss these results, Thursday, May 10, 2012 at 11:30 a.m. ET (8:30 a.m. PT). The call will be broadcast live via the Internet at www.qltinc.com. To participate on the call, please dial 1-800-319-4610 (North America) or 604-638-5340 (International) before 11:30 a.m. ET. A replay of the call will be available via the Internet and also via telephone at 1-800-319-6413 (North America) or 604-638-9010 (International), access code 9365, followed by the "#" sign.
About Synthetic Retinoid Drugs
Genetic diseases in the eye such as Leber 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, and is under investigation for the treatment of LCA and RP. QLT091001 has received orphan drug designations for the treatment of LCA and RP by the European Medicines Agency, and for the treatment of LCA and RP due to inherited mutations in the LRAT and RPE65 genes by the U.S. Food and Drug Administration (FDA). The drug has also been granted two Fast Track designations by the FDA for the treatment of the LRAT and RPE65 genetic mutations in both LCA and RP.
About Leber Congenital Amaurosis (LCA) Due to RPE65 and LRAT Mutations
LCA is an inherited degenerative retinal disease characterized by abnormalities such as roving eye movements and sensitivity to light, and manifesting in severe vision loss from birth. Both rod and cone photoreceptors are affected in LCA. Eye examinations of infants with LCA reveal normal appearing retinas. However, a low level of retinal activity, measured by electroretinography, indicates very little visual function. According to current epidemiological estimates, LCA affects approximately one in 81,000 newborns worldwide, of which approximately 10% carry the inherited deficiencies of either RPE65 or LRAT.
About Retinitis Pigmentosa (RP) Due to RPE65 and LRAT Mutations
RP is a set of hereditary retinal diseases demonstrating clinical features similar to LCA. RP is also characterized by degeneration of rod and cone photoreceptors, but it presents with a more variable loss of vision in late childhood to adulthood. Deficits in dark adaptation and peripheral vision are particular hallmarks of RP. RP is currently estimated to affect at least 300,000 individuals worldwide, of which approximately 20%–30% are autosomal recessive (arRP). It is currently estimated that less than 3% of autosomal recessive RP patients carry the inherited deficiencies of either RPE65 or LRAT.
QLT is a biotechnology company dedicated to the development and commercialization of innovative ocular products that address the unmet medical needs of patients and clinicians worldwide. We are focused on developing our synthetic retinoid program for the treatment of certain inherited retinal diseases, developing our proprietary punctal plug delivery system, as well as U.S. marketing of the commercial product Visudyne® for the treatment of wet age-related macular degeneration. QLT's head office is based in Vancouver, Canada and the Company is publicly traded on NASDAQ (symbol: QLTI) and the Toronto Stock Exchange (symbol: QLT). For more information about the Company's products and developments, please visit our web site at www.qltinc.com.
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Visudyne® is a registered trademark of Novartis AG
Eligard® is a registered trademark of Sanofi S.A.
QLT Inc. is listed on The NASDAQ Stock Market under the trading symbol "QLTI" and on The Toronto Stock Exchange under the trading symbol "QLT."
Certain statements in this press release constitute "forward-looking statements" of QLT within the meaning of the Private Securities Litigation Reform Act of 1995 and constitute "forward-looking information" within the meaning of applicable Canadian securities laws. Forward-looking statements include, but are not limited to: statements concerning our synthetic retinoid clinical development program, regulatory pathway and future plans, including our QLT091001 Phase 1b studies in LCA and RP; our clinical development goals for this stage and next stage development; statements concerning the potential benefits of QLT091001; statements concerning future data analysis expectations for potential efficacy and safety of QLT091001; statements concerning anticipated progression of our clinical trials and timing to receive data, complete final analysis and report data; and statements which contain language such as: "assuming," "prospects," "goal," "future," "projects," "believes," "expects" and "outlook." Forward-looking statements are predictions only which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those expressed in such statements. Many such risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: uncertainties relating to the timing and results of the clinical development and commercialization of our products and technologies (including, but not limited to, our punctal plug technology and synthetic retinoid program); assumptions related to continued enrollment trends, efforts and success, and the associated costs of these programs; outcomes for our clinical trials, including our synthetic retinoid program clinical trials referred to herein may not be favorable or may be less favorable than interim/preliminary results and/or previous trials on the same or a different indication treated; there may be varying interpretations of data produced by one or more of our clinical trials of QLT091001, including by QLT or regulators; the timing, expense and uncertainty associated with the regulatory approval process for products; risks and uncertainties associated with the safety and effectiveness of our technology; risks and uncertainties related to the scope, validity, and enforceability of our intellectual property rights and the impact of patents and other intellectual property of third parties; the Company's future operating results are uncertain and likely to fluctuate; currency fluctuations; the risk that sales of Visudyne® or Eligard® may be less than expected (including due to competitive products and pricing); and general economic conditions and other factors described in detail in QLT's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other filings with the U.S. Securities and Exchange Commission and Canadian securities regulatory authorities. Forward-looking statements are based on the current expectations of QLT and QLT does not assume any obligation to update such information to reflect later events or developments except as required by law. CONTACT: QLT Inc. Contacts:
office: 604.707.7000 or 1.800.663.5486
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