Isotechnika Pharma Inc. (ISA.TO) Announces That Lux Biosciences' Phase 3 Uveitis Study Did Not Meet Primary Endpoint
12/27/2012 8:44:57 AM
EDMONTON, Alberta, Dec. 27, 2012 (GLOBE NEWSWIRE) -- Isotechnika Pharma Inc. (TSX:ISA) ("Isotechnika" or the "Company") announced today that the Phase 3 clinical study using voclosporin for the treatment of non-infectious uveitis, conducted by Lux Biosciences, Inc. ("Lux") under a license agreement with Isotechnika, did not meet its primary endpoint of change from baseline in vitreous haze at 12 weeks or at the time of treatment failure, if earlier. As a result, Lux does not expect to move forward with its submission of regulatory approval applications for non-infectious uveitis in the United States and Europe.
While the successful development of voclosporin in the area of nephrology has long been Isotechnika's primary focus, the Company granted Lux worldwide rights to develop and commercialize voclosporin for ophthalmic indications in the hope that the expansion of its platform into other medical specialties might help to maximize the drug's full medical and commercial potential.
"These trial results are disappointing, for patients suffering from non-infectious uveitis, for Lux and for Isotechnika," commented Dr. Robert Foster, CEO of Isotechnika.
"However, they by no means spell the end of our core voclosporin development program," continued Dr. Foster. "Our emphasis on nephrology remains intact and we continue to have full confidence in the potential of voclosporin to address significant unmet medical needs like kidney transplant rejection and lupus nephritis."
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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