FDA Grants Permission to Isotechnika for TAFA-93 Clinical Trial
EDMONTON, Canada, July 7 (ots/PRNewswire)
Isotechnika Inc. today announced that the Company has received permission from the Food and Drug Administration of the United States for the commencement of a Phase Ib human clinical trial for TAFA-93.
TAFA-93 is a novel prodrug of the mTOR inhibitor rapamycin designed to reduce the unfavourable pharmacokinetics and side effects of rapamycin. mTOR inhibitors are currently used in the prevention of organ rejection in transplantation, in the treatment of auto-immune and oncological diseases, and as a component of coated stents for the treatment of coronary artery disease. Due to the distinct mechanism of action of TAFA-93 from calcineurin inhibitors such as ISA247, Isotechnika's lead drug, TAFA-93 has the potential to be administered as a complementary therapy along with ISA247 in the prevention of organ rejection after transplantation.
A Canadian Phase Ia trial for TAFA-93 is currently ongoing in Montreal, Quebec. Upon receipt of the preliminary data from the Phase Ia trial, Isotechnika will commence the US Phase Ib trial. The Company anticipates the commencement of the Phase Ib trial to take place this fall. Clinical trial site selection for the phase Ib trial is currently underway.
"We are extremely pleased with the FDA's decision to allow Isotechnika to move forward with a Phase Ib trial for TAFA-93," stated Dr. Randall Yatscoff, Isotechnika's President and COO. "Our drug development program continues to meet the timelines set for this year. With two of our three drug candidates now in the clinical phase we remain focused on expanding our pipeline in novel immunosuppressive drug therapies," added Yatscoff.
Forward-looking statements
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 commercialise 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.
About mTOR inhibitors
mTOR inhibitors are a class of immunosuppressive drugs which includes Rapamune(R), that inhibit T cell activation at a different stage in the immune response as compared to other classes (i.e. calcineurin inhibitors, DNA synthesis inhibitors). In transplantation, mTOR inhibitors are typically used in combination with calcineurin inhibitors. The side effects (hyperlipidemia, gastrointestinal effects, thrombocytopenia), of this class of drugs currently limit its broader use in transplantation and in the treatment of auto-immune diseases. The current market for this class of drugs is in excess of 0.5 billion USD per year globally.
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 a publicly traded company on the Toronto Stock Exchange under the symbol ISA. More information on Isotechnika can be found at www.isotechnika.com.
Contact:
Dr. Randall Yatscoff, President and COO, Isotechnika Inc., Phone:
+1-780-487-1600 extension 246, 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:
sgillis-paulgaard@isotechnika.com; Archived images on this
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