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.

-   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."

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 http://www.isotechnika.com.

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: [email protected]; Stephanie
Gillis-Paulgaard, Director, Corporate Communications, Isotechnika
Inc., Phone: +1-780-909-4661, Fax: +1-780- 484-4105,
E-mail:[email protected]/

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

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