Isotechnika Inc.

Isotechnika Inc. Announces Promising Results From Phase I TAFA93 Trials

    Edmonton, Alberta (ots/PRNewswire) -

    - Isotechnika Inc. announced today promising results from its Phase I TAFA93 trials. TAFA93, a pro-drug of rapamycin, is a novel small molecule  mTOR inhibitor, which is a class of drugs currently used in the prevention of  organ rejection in transplantation. mTOR inhibitors are typically used in  combination with calcineurin inhibitors after organ transplant. mTOR  inhibitors also have potential use in oncology and in cardiac stent  technology.

    A TAFA93 Phase Ia single center, randomized, placebo-controlled, Single  Ascending Dose (SAD) trial commenced in July, 2004. The results indicated  that doses of 0.04, 0.08 and 0.16 mg/kg TAFA93 taken once daily were safe and  well tolerated in healthy volunteers. No serious adverse events were  reported. The data obtained from the Phase Ia trial was used to ascertain the  most appropriate dose levels for the Phase Ib clinical trial.

    Earlier this year a Phase Ib, single center, randomized, placebo- controlled, Multiple-Ascending Dose (MAD), double-blind trial was conducted  with TAFA93. The primary objective of this study was to assess the  tolerability, safety and pharmacokinetics of multiple doses of TAFA93 in  healthy volunteers. Thirty six subjects were randomized to receive either  placebo or oral doses of TAFA93 (0.04, 0.08 or 0.16 mg/kg once daily) for 13  consecutive days.

    Overall, the Phase Ib TAFA93 trial suggested that the drug was very well  tolerated. No serious adverse events were reported during the trial. TAFA93  administration in the dose range of 0.04 mg/kg to 0.16 mg/kg resulted in  dose-proportional rapamycin pharmacokinetics, following both single and  multiple doses with stable and linear pharmacokinetics. In addition, the  pharmacokinetic profiles display less peak-to-trough variability due to a  modified input of the drug, when compared to historical rapamycin data.

    The successful completion of the Phase I TAFA93 trials fulfills one of  our commitments to Atrium Medical Corporation ("Atrium") and allows Atrium to  continue moving forward with their drug eluting stent technology program.

    "Our theory is that having drug concentrations within a therapeutic  window for a longer period of time may be beneficial giving immunosuppressive  coverage for a more prolonged period of time," stated Dr. Randall Yatscoff,  Isotechnika's President and CEO. "These results from these trials are  consistent with this theory. This may result in optimized immunosuppressive  efficacy and reduced side effects normally associated with this drug class."

    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 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 is an immunosuppressant currently in  an extension protocol of a Canadian Phase III human clinical trial for the  treatment of moderate to severe psoriasis and a North American Phase IIb  human clinical trial for the prevention of kidney graft rejection. The  Company also has an additional immunosuppressive compound in its drug  pipeline, TAFA93 which is in Phase I.

    Isotechnika Inc. is a publicly traded company on the Toronto Stock Exchange under the symbol ISA. More information on Isotechnika can be found  at

    Isotechnika's Partnership with Atrium Medical Corporation

    In September, 2005, Isotechnika signed an exclusive worldwide licensing  agreement for the use of TAFA93 and ISA247 specifically with drug eluting  devices for the non-systemic treatment of vascular, cardiovascular disorders,  target vessel and tissue disorders.

    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 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.
Im Internet recherchierbar:

Dr. Randall Yatscoff, President & CEO, Isotechnika Inc.,
+1(780)-487-1600 (246), +1(780)-484-4105 (fax),; Stephanie Gillis-Paulgaard, Director,
Corporate Communications, Isotechnika Inc., +1(780)-909-4661,
+1(780)-484-4105 (fax),

Weitere Meldungen: Isotechnika Inc.

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