EDMONTON, Alberta, May 4, 2007 – Isotechnika Inc. (TSX:ISA) announced today that the Company’s lead drug, ISA247, referred to as LX211 by our partner Lux Biosciences, has been selected as the subject of two presentations at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting, being held May 6-10 in Fort Lauderdale, Florida.
The first, an oral presentation being given on May 5 during a satellite session of the American Uveitis Society by Dr. Quan Dong Nguyen, Johns Hopkins University, discusses the ongoing LUMINATE (Lux Uveitis Multicenter Investigation of a New Approach to TrEatment) Phase 2/3 Clinical Trial Program. The three LUMINATE trials represent the first clinical development program aimed at supporting regulatory approval of a corticosteroid-sparing immunosuppressive agent in different types of sight-threatening, non-infectious uveitis.
The second, a poster presented by Matthew A. Cunningham, National Eye Institute, discusses preclinical data demonstrating the ability of subcutaneous injections of LX211 to prevent and reverse experimental autoimmune uveoretinitis (EAU) in rats. Cunningham commented, “We observed that in this animal model, LX211 could both prevent the onset of disease as well as reverse EAU at doses as low as 10mg/kg. These preclinical results clearly support our view that LX211 may play an important future role in the treatment of uveitis.”
“These positive preclinical results, combined with encouraging safety data from human clinical trials in other indications conducted by our partner Isotechnika, provide a strong rationale for our ongoing registration-directed LUMINATE studies of LX211 in uveitis,” said Ulrich Grau, Ph.D., Lux Biosciences’ president and chief executive officer. “We hope to complete enrollment in the LUMINATE trial program by early 2008 and, if suc cessful, seek regulatory approval for LX211 in late 2008.”
Dr. Randall Yatscoff, Isotechnika’s President & CEO commented, “We are encouraged by the preclinical data seen to date and we look forward to working with Lux Biosciences to facilitate meeting their clinical development timelines. Uveitis is the third indication that ISA247 (LX211) is currently being developed for. Late-stage clinical trials are also being conducted with ISA247 for the treatment of moderate to severe psoriasis and the prevention of kidney graft rejection.”
For More Information:
Dr. Randall Yatscoff Stephanie Gillis-Paulgaard
President & CEO Director, Corporate Communications
Isotechnika Inc. Isotechnika Inc.
780-487-1600 (247) 780-909-4661
780-484-4105 (fax) 780-484-4105 (fax)
Edmonton-based Isotechnika Inc. is an international biopharmaceutical company focused on the discovery and development of novel immunosuppressive therapeutics that are safer than currently available treatments. Isotechnika looks to become the leader in development of immunosuppressant therapies.
Isotechnika's lead drug, ISA247, has successfully completed a
Phase 3 Canadian trial for the treatment of moderate to severe
psoriasis. ISA247 is currently being investigated in a combined
Phase 3 European/Canadian psoriasis trial and a Phase 2b North
American trial for the prevention of kidney graft rejection. On
our partners, Lux Biosciences, has received permission from the
Food and Drug Administration to investigate ISA247 in three
separate pivotal Phase 2/Phase 3 trials for the treatment of
non-infectious uveitis and as a maintenance therapy in
Isotechnika Inc. is a publicly traded company on the Toronto
Stock Exchange under the symbol "ISA". More information on
Isotechnika can be found at www.isotechnika.com.
Partnerships with Isotechnika Inc.
Isotechnika Inc. signed a collaboration agreement with Hoffman La Roche on April 9, 2002, which licensed the worldwide rights to develop and commercialize voclosporine for all transplant indications.
On September 30, 2005, Isotechnika Inc. entered into an exclusive worldwide licensing agreement with Atrium Medical Corporation for the use of voclosporine and TAFA93 specifically with drug eluting devices for the non-systemic treatment of vascular, cardiovascular, target vessel and tissue disorders.
Isotechnika Inc. and Cellgate Inc. signed an option agreement on April 25, 2006, granting Isotechnika the option to obtain an exclusive license to develop and commercialize conjugates consisting of Cellgate's patented transporter technology for the topical delivery of voclosporine in patients suffering from mild to moderate psoriasis.
On May 25, 2006, Isotechnika Inc. signed an agreement with Lux Biosciences, Inc. of Jersey City, New Jersey granting Lux Biosciences worldwide rights to develop and commercialize Isotechnika’s lead drug, voclosporine for the treatment and prophylaxis of all ophthalmic diseases.
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