Isotechnika Inc.

Isotechnika Reports Final Results of the PROMISE Trial

    Edmonton, Canada (ots/PRNewswire) - Isotechnika Inc. (TSX:ISA) today announced positive results from the  Phase 2b PROMISE trial which evaluated the Company's lead drug, voclosporin , in de novo kidney transplant patients. This trial was designed to determine the most appropriate dosing strategy for the Phase 3 program in  kidney transplantation.

    "PROMISE has shown that the efficacy of voclosporin is statistically  non-inferior when compared to the market leader, tacrolimus in all three  dose groups," stated Dr. Robert Foster, Isotechnika's Chairman & CEO. " While matching tacrolimus in efficacy, key safety advantages such as a  lower incidence of new onset diabetes mellitus (NODM) and preservation of  kidney function were shown. In addition to highlighting these key safety  advantages, the wide therapeutic window was confirmed. This window will  enable clinicians to maximize both efficacy and safety, therefore offering significant clinical benefit compared to the other calcineurin inhibitors."

    Efficacy Results:

    The primary efficacy objective of this trial was to demonstrate non- inferiority in biopsy proven acute rejection (BPAR) in de novo kidney  transplant patients receiving voclosporin as compared to tacrolimus at six  months. This objective was achieved and non inferiority was established for  each of the three voclosporin treatment groups.

    Safety Results:

    The safety profile of voclosporin compared to tacrolimus was evaluated  by multiple assessments including NODM, kidney function, hypertension,  hyperlipidemia, SAEs, AEs, and laboratory values. Based on these  assessments no specific safety concerns were raised and the following key  advantages were noted.

@@start.t1@@        -    A statistically lower incidence of NODM at six months post
              transplantation was observed in the low dose voclosporin group
              compared to the tacrolimus group (1.6% vs. 16.4% respectively).
              Although not statistically different, the incidence of NODM was also
              noted to be lower in the mid dose voclosporin group compared to the
              tacrolimus group (5.7% vs. 16.4%, respectively).
              "The use of voclosporin at the mid dose reduced the risk of
              developing NODM by 65% when compared to tacrolimus in de novo kidney
              transplant patients over six months," stated Dr. Richard Lewanczuk,
              Professor, Division of Endocrinology at the University of Alberta.
              "The reduced risk of developing NODM has highly favorable
              implications from a clinical perspective."
        -    Based on the multiple assessments of kidney function, there were no
              statistically significant differences between the low and mid dose
              voclosporin groups and the tacrolimus group over six months. In
              patients who received a living donor kidney, there was a 7.3%
              improvement in kidney function (iothalamate GFR) in the mid dose
              voclosporin group vs. tacrolimus.
              Dr. Herwig Ulf Meier-Kriesche, Professor of Medicine and Clinical
              Director of Renal Transplant in the Department of Medicine,
              University of Florida added, "When compared to results of other
              calcineurin inhibitors such as tacrolimus or cyclosporin, these are
              very encouraging results."@@end@@

    The final Phase 2b results will be presented at the upcoming American  Transplant Congress.

      North American Phase 2b Kidney Transplant Trial Design

    Forty-two centers across North America have been contracted to perform  the trial, including thirty-eight centers in the United States and four  centers in Canada. The primary endpoint of the trial was defined as non- inferiority in biopsy proven acute rejection (BPAR) episodes in patients  receiving voclosporin for six months as compared to the tacrolimus control  which is currently the leading North American transplant drug in this class . Additionally, kidney function and other laboratory parameters were  monitored throughout the trial. The use of the other two calcineurin  inhibitors, cyclosporin and tacrolimus, are often associated with  significant safety concerns.

    A total of 334 de novo (newly transplanted) kidney transplant patients  were enrolled in the trial. Patients were placed into one of four separate  treatment groups; three different dose groups of voclosporin (0.4 mg/kg,  0.6 mg/kg, and 0.8 mg/kg twice daily) compared with the fourth group, a  tacrolimus control arm (0.05 mg/kg twice daily). Patients in all four  treatment groups had their doses adjusted in order to achieve pre-defined  blood levels of either voclosporin or tacrolimus. All patients received  oral dosing with the drug (voclosporin or tacrolimus) over a six month  period along with other standard immunosuppressive therapies used following transplantation.

      About Isotechnika

    Edmonton-based Isotechnika Inc. is an international biopharmaceutical  company focused on the discovery and development of novel immunosuppressive  therapeutics that are designed to offer advantages over other currently  available treatments. There is a significant unmet medical need in the  treatment of both solid organ transplantation and autoimmune disease. It is  estimated that the market potential will exceed $4 billion annually in  sales for calcineurin inhibitors such as voclosporin by 2010.

    Voclosporin is a next generation calcineurin inhibitor, which recently  completed a Phase 2b North American trial for the prevention of kidney  rejection following transplantation. An extension to the Phase 2b trial and  a combined Phase 3 European/Canadian trial for the treatment of moderate to  severe psoriasis are ongoing. Our partner, Lux Biosciences, is currently conducting three separate Phase 2/3 pivotal trials investigating voclosporin (referred to as LX211 by Lux) for the treatment of uveitis.

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

      Forward-Looking Statements

    This press release may contain forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties  and other factors that may cause actual results, events or developments to  be materially different from any future results, events or developments  expressed or implied by such 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,  securing and maintaining corporate alliances, the need for additional  capital and the effect of capital market conditions and other factors on  capital availability, 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, competition, 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. Additional risks and uncertainties relating to the  Company and its business can be found in the "Risk Factors" section of the  Company's Annual Information Form. These factors should be considered  carefully and readers are cautioned not to place undue reliance on such  forward-looking statements.

    For further information: Dr. Robert Foster, Chairman & CEO, Isotechnika  Inc., Phone: +1-780-487-1600 (x247), Fax: +1-780-484-4105, E-mail:; Stephanie Gillis-Paulgaard, Director, Corporate  Communications, Isotechnika Inc., Phone: +1-780-909-4661, Fax: +1-780- 484-4105,

ots Originaltext: Isotechnika Inc.
Im Internet recherchierbar:

For further information: Dr. Robert Foster, Chairman & CEO,
Isotechnika Inc., Phone: +1-780-487-1600 (x247), Fax:
+1-780-484-4105, E-mail:; Stephanie
Gillis-Paulgaard, Director, Corporate Communications, Isotechnika
Inc., Phone: +1-780-909-4661, Fax: +1-780- 484-4105,

Weitere Meldungen: Isotechnika Inc.

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