Isotechnika Pharma reports voclosporin Phase 2/3 clinical trial results at the AAO meeting

Oct 27 2009

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.

"The LX211-02 study was a double-masked, placebo-controlled, dose-ranging study that included 232 patients at 57 centers in North America, Europe and India with clinically inactive uveitis involving any location within the eye," said Professor Bodaghi. "Results of this trial showed that LX211 was able to reduce recurrence of inflammation by 50% over placebo at the 0.4 mg/kg twice daily dose - a p-value of less than 0.05 - and may therefore effectively increase the interval between inflammatory relapses to 24 months compared to 10 months with placebo."

Professor Bodaghi also commented that, "Given that inflammatory exacerbation is a direct trigger of vision loss, this result for LX211 is impressive. In addition to a marked reduction in recurrence of inflammation, visual acuity was preserved in this study. Moreover, these results suggest the potential for disease modification whereby treatment with LUVENIQ alters the course of the disease leading ultimately to improved outcomes in this difficult-to-treat condition."

"Non-infectious uveitis involving the posterior segment of the eye is a leading cause of vision loss and long-term disability and the fourth leading cause of legal blindness in the industrialized world," said Ulrich Grau, Ph.D., Lux Biosciences' President and CEO. "As the majority of patients are first diagnosed at ages under 40 years, the socio-economic burden of uveitis is higher than that of other serious ocular conditions such as AMD and diabetic macular edema. The results from these clinical trials suggest that LX211 may have the potential to significantly change the face of uveitis therapy, based on its ability to modify the course of the disease. This is analogous to the advent of disease-modifying anti-rheumatic drugs (DMARDs) and their impact on the course of rheumatoid arthritis."