Positive Data From Trans-ISA247 Single Ascending Dose Trial
EDMONTON, Canada, July 6 (ots/PRNewswire)
Isotechnika Inc. (TSX:ISA) announced today the completion of the single ascending dose trial for the Company's lead immunosuppressive drug candidate, ISA247. The SAD trial was conducted in healthy volunteers using the trans-ISA247 formulation to assess the appropriate dosage of the enhanced composition of the drug.
The data confirms that the trans formulation of ISA247 is approximately 1.5 times more potent than the original mixture and up to 5 times more potent than cyclosporine. Additionally, the results demonstrate an even stronger correlation between blood drug concentration and the observed immunosuppressive effect confirming the reduction in inter-patient and intra-patient variability. This finding is significant, as there is a very poor correlation between patient's blood concentrations of drugs such as cyclosporine and the observed immunosuppressive effect. Hence, therapeutic drug monitoring (TDM) of ISA247 will allow for optimisation of clinical response while minimising the potential for adverse drug events.
Our original formulation of ISA247 (consisting of two geometric isomers: cis and trans) was less nephrotoxic than cyclosporine. Results of the current SAD trial indicate that drug effects of trans-ISA247 on the kidney have been reduced even further than the original formulation suggesting that trans-ISA247 offers significant advantages over currently used calcineurin inhibitors such as cyclosporine.
"The SAD trial met all primary and secondary endpoints with no serious adverse events," stated Dr. Randall Yatscoff, Isotechnika's President and COO. "The results with trans-ISA247 far exceeded our expectations. The therapeutic window with this formulation appears to be wider than that previously observed with the original formulation. These results validate our decision to move forward with the trans formulation of ISA247 and facilitate Isotechnika meeting its drug development timelines for this year."
Forward-looking statements
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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, TAFA-93 and TKB662. TAFA-93 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 TAFA-93 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. Isotechnika Inc. is an S&P/TSX Composite Index company publicly traded under the symbol ISA. More information on Isotechnika can be found at www.isotechnika.com.
Contact:
Dr. Randall Yatscoff, President & COO, Isotechnika Inc., Phone:
+1-780-487-1600, Fax: +1-780-484-4105, E-mail:
ryatscoff@isotechnika.com; Stephanie Gillis-Paulgaard, Manager,
Corporate Communications, Isotechnika Inc., Phone: +1-780-487-1600
extension 243, Fax: +1-780-484-4105, E-mail:
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