EDMONTON, Feb. 24 /CNW/ - Isotechnika Pharma Inc. (TSX: ISA) announced
today that Lux Biosciences, Inc. (Lux) has commenced its pivotal Phase
3 trial using voclosporin for the treatment of non-infectious uveitis,
a leading cause of vision loss and long-term disability.
The study is a 6-month randomized trial of voclosporin versus placebo in
patients with active non-infectious intermediate, posterior, or
pan-uveitis. This Phase 3 trial will involve 150 patients in North
America and Europe. Lux is conducting this additional Phase 3 trial as
outlined in the Complete Response Letter received in August, 2010, from
the United States Food and Drug Administration (FDA).
"We are pleased with Lux's continuing commitment to move voclosporin
forward in non-infectious uveitis," stated Dr. Robert Foster, President
& CEO of Isotechnika Pharma.
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. Voclosporin (branded as Luveniq™ by Lux) was
accepted for review by the European Medicines Agency (EMA) in March
2010. The product has received Orphan Drug designation in both Europe
and the US for the treatment of non-infectious uveitis.
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 $3.0 billion market for this class of immunosuppressants.
Isotechnika Pharma Inc. is a publicly traded company 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.
We seek safe harbor.
SOURCE Isotechnika Pharma Inc.
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