EDMONTON, May 2 /PRNewswire-FirstCall/ - Isotechnika Inc. today announced that its partner, Lux Biosciences, has received a No Objection Letter from Health Canada to investigate ISA247, referred to as LX211 by Lux, in Phase 2/3 clinical trials for the treatment of uveitis.
Lux Biosciences commenced patient treatment in its LUMINATE (Lux Uveitis Multicenter Investigation of a New Approach to TreatmEnt) pivotal clinical trial program earlier this year in the United States. The pivotal trial program, which consists of three controlled, double masked studies, is investigating the use of ISA247 in different forms of active uveitis in addition to maintenance of quiescent disease.
The three LUMINATE clinical trials will be conducted in parallel with a high degree of overlap among study sites, with approximately 50 sites in North America, Europe and India expected to enroll approximately 500 patients. Efficacy is measured at 6 months assessing the degree of inflammation, utilizing standardized scales for evaluation of inflammation in the anterior (front) and posterior (back) segments of the eye. Interested parties are encouraged to visit www.clinicaltrials.gov for further information on the trial designs.
Dr. Randall Yatscoff, Isotechnika's President & CEO stated, "Receipt of the No Objection Letter will allow Lux to proceed with their clinical trial program in Canada. Additionally, Lux has received regulatory approval to conduct trials in Germany, Austria, France, and the United Kingdom."
About Uveitis
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Uveitis is an autoimmune disease characterized by chronic inflammation of the eye. There is substantial evidence implicating T-lymphocytes, key cells involved in inflammatory processes, in the development of the disease. Uveitis is an under-diagnosed and under-recognized medical condition that causes vision impairment, ocular pain, and loss of vision. Experts estimate that 10% of new U.S. cases of blindness result from this disease. Approximately 300,000 people suffer from uveitis in the United States alone, the majority of whom are affected by anterior uveitis. The only therapeutic class approved by the FDA for treatment of uveitis is corticosteroids, which are burdened with multiple side effects, such as hypertension, hyperglycemia, hypercholesterolemia, and in the eye, cataract formation and glaucoma.
About Isotechnika
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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. One of 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 uveitis.
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.
About Lux Biosciences Inc.
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Founded in 2005, Lux Biosciences is a privately held biotechnology company dedicated to the identification, optimization, development and commercialization of products for the treatment of ophthalmic diseases. The company has assembled a portfolio of product candidates based on compounds with demonstrated utility in non-ophthalmic indications that offer potential to address major market opportunities in the ophthalmic field. ISA247, the most advanced of these, is expected to enter pivotal clinical trials for the treatment of uveitis by early 2007 and additionally offers a pipeline of other potential product applications. More information on Lux Biosciences can be found at www.luxbio.com.
Forward-Looking Statements
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This press release may contain forward-looking statements. Forward looking statements, including the Company's belief as to the potential of its products, the Company's expectations regarding the issuance of additional patents and the Company's ability to protect its intellectual property, involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the ability to economically manufacture its products, the potential of its products, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize its products, the ability of the Company to defend its patents from infringement by third parties, and the risk that the Company's patents may be subsequently shown to be invalid or infringe the patents of others. Investors should consult the Company's quarterly and annual filings with the Canadian commissions for additional information on risks and uncertainties relating to the forward- looking statements. Investors are cautioned against placing undue reliance on forward-looking statements.
Isotechnika Inc.CONTACT: Dr. Randall Yatscoff, President & CEO, Isotechnika Inc., Phone:(780) 487-1600 Ext. 246, Fax: (780) 484-4105, Email:ryatscoff@isotechnika.com; Stephanie Gillis-Paulgaard, Director, CorporateCommunications, Isotechnika Inc., Phone: (780) 909-4661, Fax: (780)484-4105, E-mail:sgillis-paulgaard@isotechnika.com
