EDMONTON, Feb. 20 /PRNewswire-FirstCall/ - Isotechnika Inc. announced today that its partner, Lux Biosciences has begun treating patients in its LUMINATE (Lux Uveitis Multicenter Investigation of a New Approach to TreatmEnt) pivotal clinical trial program. The pivotal trial program, which consists of three controlled, double masked studies, is investigating the use of ISA247 (which is referred to as LX211 by Lux) 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.
"Each of these trials targets a different patient population, including patients whose disease is active, and patients who are currently controlled by steroids and/or steroid-sparing agents but where LX211 may provide further advantages in terms of safety and efficacy," said Ulrich Grau, Ph.D., Lux Biosciences' President and Chief Executive Officer. "Our overall development program for LX211 continues according to plan, and we hope to complete enrollment in the LUMINATE trials by early 2008 and, if successful, seek regulatory approval for LX211 in late 2008."
"We are pleased that Lux Biosciences has facilitated the advancement of ISA247 (LX211) into pivotal trials for uveitis in an expeditious manner," stated Dr. Randall Yatscoff, Isotechnika's President & CEO.
Further details regarding each of the three protocols, LUMINATE-Active (LX211-01), LUMINATE-Maintenance (LX211-02) and LUMINATE-Anterior (LX211-03) are available on the website http://clinicaltrials.gov.
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 Inc.
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Isotechnika Inc. is an international biopharmaceutical company headquartered in Edmonton, Alberta, Canada. Drawing upon its expertise in medicinal chemistry and immunology, the Company is focused on the discovery and development of novel immunosuppressive therapeutics that are safer than currently available treatments. Its entrepreneurial management and world-class team of scientists are building a pipeline of immunosuppressive drug candidates for treatment of autoimmune diseases and for use in the prevention of organ rejection in transplantation. Isotechnika looks to become the leader in development of immunosuppressant therapies.
Isotechnika's lead compound, ISA247 has successfully completed a Phase III Canadian trial for the treatment of moderate to severe psoriasis. ISA247 is currently being investigated in a combined Phase III European/Canadian psoriasis trial and a Phase IIb North American trial for the prevention of kidney graft rejection. The Company also has an additional immunosuppressive compound in its drug pipeline, TAFA93 which successfully completed Phase I clinical trials.
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.
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Isotechnika Inc. signed a collaboration agreement with Hoffman La Roche on April 9, 2002, which licensed the worldwide rights to develop and commercialize ISA247 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 ISA247 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 ISA247 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, ISA247 for the treatment and prophylaxis of all ophthalmic diseases.
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., (780)909-5042, (780) 484-4105, ryatscoff@isotechnika.com; StephanieGillis-Paulgaard, Director, Corporate Communications, Isotechnika Inc.,(780) 909-4661, (780) 484-4105 (fax), sgillis-paulgaard@isotechnika.com;Lux Biosciences, Inc. Contact Information: Ulrich Grau, Ph.D., (201)946-0221, ulrich.grau@luxbio.com; Kureczka/Martin Associates (media), JoanKureczka, (415) 821-2413, jkureczka@comcast.net
