-- Partner Lux Biosciences Preparing to File for US and European Approvals --
Isotechnika Pharma Inc. (TSX:ISA) today announced that results of the international Phase 2/3 clinical trials studying voclosporin, conducted by its partner Lux Biosciences, were the subject of two podium presentations at the American Association of Ophthalmology (AAO) meeting and of a presentation at the satellite meeting of the American Uveitis Society (AUS) in San Francisco, October 24-27. The presentations highlighted the ability of voclosporin (LX211, LUVENIQ(TM)) to control the inflammation that characterizes this potentially blinding eye disease and significantly reduce its rate of recurrence. Isotechnika's partner, Lux Biosciences, plans to file a New Drug Application (NDA) and a Marketing Authorization Application (MAA) for marketing approvals around year-end 2009 and early 2010 in the United States and Europe, respectively, making it possible for voclosporin to become the first approved oral treatment capable of modifying the course of uveitis, a group of serious eye conditions frequently associated with either severe vision loss or substantial morbidity from steroid use.
"I am very impressed with the results and excited about Lux Biosciences' rapid march towards commercialization with our drug, voclosporin," said Dr. Robert Foster, President and CEO of Isotechnika Pharma. "Moreover, these findings support the safety profiles we have observed in Isotechnika's psoriasis and kidney transplant studies, and are something Isotechnika stakeholders will see bearing fruit as Lux continues advancing towards voclosporin's first FDA approval and expected subsequent launch."
AAO Presentations - Professor Bahram Bodaghi, M.D., Ph.D., Pitié Salpétrière Hospital Paris, France, presented study results from the LX211-02 study on Monday, October 26 at 8:50 am PT at the AAO; - Dr. Quan D. Nguyen, M.D., of the Wilmer Eye Institute at The Johns Hopkins University, Baltimore, MD, presented study results from the LX211-01 study on Monday, October 26 at 9:00 am PT at the AAO; - Dr. C. Stephen Foster, MD, President, Massachusetts Eye Research and Surgery Institution (MERSI), presented on the ability of voclosporin to control inflammation and to significantly delay recurrence of inflammatory exacerbation compared to the control group at AUS on Sunday, October 25 at 8:00 pm PT.