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Isotechnika Inc. Achieves all Endpoints in Multiple Ascending Dose Study for ISA247
Edmonton, Canada, November 3 (ots/PRNewswire) - Isotechnika Inc. announced today that the Company has successfully completed the multiple ascending dose study for its lead immunosuppressive drug, ISA247.
The multiple ascending dose (MAD) study for ISA247 that commenced on June 3, 2004 involved a total of 43 subjects. The study, conducted by SFBC Anapharm in Montreal, Quebec achieved all safety endpoints. Healthy volunteers were administered ISA247 with the first dose being 0.25 mg/kg given orally twice daily for a total of 10 days. On subsequent occasions, separate groups of volunteers were administered dosages of either 0.5, 1.0, or 1.5mg/kg given twice daily for a total of 10 days. At anticipated therapeutic doses for psoriasis treatment, subjects experienced no clinically significant impact on renal function as measured either by serum creatinine or 24-hour creatinine clearance determinations. Final dosing recommendations, however, will be determined in a planned upcoming Phase III clinical trial in psoriasis patients. Other currently marketed medications belonging to the same therapeutic class of drugs (i.e. calcineurin inhibitors) exhibit clinically significant deleterious effects on kidney function at therapeutic doses. The absence of these renal effects with ISA247, therefore, is significant. Furthermore, no serious adverse events were observed for any other body system examined in the study.
In addition to the completion of the MAD study, two additional studies were successfully finished; a food effect and a bioequivalence study.
"We fully expected that these last few trials would be completed successfully. The results obtained reconfirm our decision to move forward with the more therapeutically active trans-ISA247. The trans-ISA247 formulation is a more potent immunosuppressant, has better predictability between dosing and resultant blood concentrations, and allows dosing at therapeutic blood concentrations of drug without significant side-effects so commonly encountered with this class of important drugs," stated Dr. Randall Yatscoff, Isotechnika's President & COO. "We are well poised to enter a Phase III clinical trial for psoriasis treatment later this year."
The management team will provide a scientific update to the investment community this morning commencing at 9:00 a.m. EST/ 7:00 a.m. MST. All Interested parties can access the live web cast (listen only mode) by entering http://www.newswire.ca/en/webcast/viewEvent.cgi?eventID(equal sign)955240 in their web browser. Alternatively, you may access the web cast through our corporate Web site at www.isotechnika.com. The web cast will be archived for a 90 day period through the web cast archives at www.newswire.ca.
About Isotechnika Inc.
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 use in the prevention of organ rejection in transplantation and in the treatment of autoimmune diseases. Isotechnika looks to become the leader in development of immunosuppressant therapies.
Isotechnika's lead drug, ISA247, presently referred to as trans-ISA247, is an immunosuppressant that has successfully completed a Phase II trial for psoriasis and Phase IIa trial for kidney transplantation. Isotechnika recently expanded its product pipeline by developing two additional novel immunosuppressive compounds, TAFA93 and TKB662. TAFA93 is a novel small molecule mTOR inhibitor, a class of drugs currently used in the prevention of organ rejection in transplantation and as a coated stent therapy in the treatment of coronary artery disease. Pre-clinical studies of TKB662 have demonstrated inhibition of T cell and B cell activation and proliferation through multiple mechanisms of action including the inhibition of lymphocyte phosphorylation activity. As both TAFA93 and TKB662 have distinct mechanisms of action from calcineurin inhibitors such as ISA247 they have the potential to be administered as complementary therapies in both prevention of organ rejection and treatment of autoimmune diseases.
In addition to the Company's drug pipeline, Isotechnika also has a diagnostic division, which includes the Helikit(TM) and Diatest(TM) breath kits. The Helikit(TM), a 13C breath test is used for the detection of H.pylori, a bacterium that infects a large portion of the population. The Helikit(TM) is currently sold internationally. The Diatest(TM), a 13C glucose breath test is used for the detection of insulin resistance. The Company expects to commence the necessary clinical trials in 2005 involving the Diatest(TM) to obtain regulatory approval in the United States. 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.
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.
ots Originaltext: Isotechnika Inc.
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