EDMONTON, Alberta, July 9, 2012 (GLOBE NEWSWIRE) -- Isotechnika Pharma Inc. (TSX:ISA) ("Isotechnika") announced today that Lux Biosciences, Inc. ("Lux") has completed patient enrollment in its Phase 3 clinical study using voclosporin (branded as Luveniq™ by Lux) for the treatment of non-infectious uveitis, a leading cause of vision loss and long-term disability. Lux anticipates that data from the Phase 3 study will be available early in the first quarter of 2013.
The Phase 3 study is a six-month, randomized, multi-center, double-masked, controlled trial to evaluate the efficacy and safety of Luveniq for the treatment of non-infectious uveitis involving the intermediate or posterior segments of the eye. The study includes 155 patients and is taking place at 56 sites across North America, Europe and Brazil. The primary endpoint of the trial is the change from baseline in vitreous haze at 12 weeks or at the time of treatment failure, if earlier.
Lux anticipates that the results from this trial, if positive, will address the U.S. Food and Drug Administration's request for additional clinical information as part of the Complete Response letter regarding the New Drug Application ("NDA") for Luveniq issued in August 2010, and will support a resubmission of the NDA under priority review early in 2013. Lux additionally expects the trial results, if positive, to support a regulatory filing to the European Medicines Agency for Luveniq. The product has received Orphan Drug designation in both Europe and the United States for the treatment of non-infectious uveitis.
In 2006, Isotechnika granted Lux worldwide rights to develop and commercialize voclosporin for ophthalmic diseases. In return, Isotechnika will receive development milestones payments, as well as royalties on net sales.
"We are very pleased with Lux's progress in moving voclosporin forward in non-infectious uveitis," stated Dr. Robert Foster, Isotechnika's CEO.
About Isotechnika Pharma Inc.
Isotechnika Pharma Inc. is a biopharmaceutical company focused on the discovery and development of immunomodulating therapeutics designed to offer key safety advantages over currently available treatments. Its lead drug, voclosporin, is a calcineurin inhibitor, and is targeted at the estimated US$3.0 billion market for this class of immunosuppressants. Isotechnika Pharma Inc. trades on the Toronto Stock Exchange under the symbol "ISA". More information on Isotechnika Pharma can be found at www.isotechnika.com or www.sedar.com.
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