Isotechnika announces Phase 3 ESSENCE data meets primary endpoint in psoriasis



    EDMONTON, April 28 /CNW/ - Isotechnika Inc. (TSX:ISA) today announced
that its ESSENCE Phase 3 trial of voclosporin in moderate to severe psoriasis
patients successfully met the primary endpoint of superiority to placebo in
the proportion of patients achieving a score of "clear" or "almost clear" in
the Static Physician's Global Assessment (SPGA) at 12 weeks of treatment. The
data will be presented in more detail at the upcoming Canadian Dermatology
Association 84th Annual Conference in Vancouver, B.C., Canada on July 1 to 5,
2009.
    In the voclosporin arm 35% of patients achieved a "clear" or "almost
clear" SPGA score at 12 weeks compared to 6% of patients receiving placebo (p
(less than) 0.001). Another widely used measure of efficacy for psoriasis
treatments is the reduction in the Psoriasis Area and Severity Index (PASI).
In the voclosporin arm 43% of patients at 12 weeks and 46% of patients at 60
weeks achieved a 75% reduction in PASI (PASI-75) and 67% of patients at 12
weeks and 68% of patients at 60 weeks achieved a 50% reduction in PASI
(PASI-50).
    In addition to the placebo control, the study also included an active
comparator arm, cyclosporine. The secondary endpoint of non-inferiority to
cyclosporine, which had a score of "clear" or "almost clear" in SPGA in 53% of
patients, was not met.
    "While we would have liked to have seen 'non-inferiority', we are pleased
with the risk-benefit of voclosporin and consider it a valuable treatment
option. This is true particularly in light of the reported lower 12 week
PASI-75 scores of the market leading treatment, etanercept", explains Dr.
Foster, President & CEO of Isotechnika.
    "The results from the ESSENCE study confirm the safety profile of
voclosporin", stated Dr. Wayne Gulliver, one of the Canadian Principal
Investigators for ESSENCE. "The efficacy seen with voclosporin combined with a
reduced number of risk factors for cardiovascular disease fills an unmet need
for patients and should be readily adopted."
    Voclosporin demonstrated positive outcomes on other pre-specified
secondary endpoints at 24 weeks reported in a descriptive manner. In each of
these safety parameters, the advantages observed in the voclosporin arm at
week 24 versus the cyclosporine arm were maintained through to week 60 of the
study. In particular, the cardiorenal risk associated with voclosporin appears
to be reduced as the incidence of triglyceride elevation, hypertension and
renal adverse effects were all lower than for cyclosporine. In addition,
voclosporin showed clear improved safety over cyclosporine with regards to
headache, pareasthesia, and hirsutism.

    
    The table below summarizes the most important adverse events over 60
    weeks.

    Adverse Event                           Voclosporin      Cyclosporine
    Hypertension                                9.4%             14.7%
    Headache                                    7.3%             12.4%
    Paraesthesia                                0.8%              7.0%
    Nausea                                      3.4%              6.2%
    Nasopharyngitis                             2.9%              6.2%
    Blood Creatinine Increased                  2.3%              5.4%
    Fatigue                                     2.6%              5.4%
    Hair Growth Abnormal                        0.3%              3.9%
    Blood Urea Increased                        0.3%              3.1%
    Muscle Spasms                               0.8%              3.1%
    Diarrhea                                    4.4%              2.3%
    

    "ESSENCE has confirmed the previous safety and efficacy data from our
Canadian Phase 3 trial", explains Dr. Foster. "We believe that it provides an
essential addition to the armamentarium of Dermatologists to treat this
debilitating disease. Our objective was to show that voclosporin is of
significant value to patients and physicians and provides a serious treatment
alternative."

    ESSENCE TRIAL DESIGN
    The randomized Phase 3 ESSENCE trial enrolled a total of 642 patients
across centers in Germany, Poland and Canada. The trial consisted of three
arms with patients randomized to receive voclosporin (0.4 mg/kg twice daily),
placebo, or cyclosporine (1.5 mg/kg twice daily) as an oral administration on
a 3:1:1 basis for a 24 week treatment period. At the end of 12 weeks of
treatment patients in the placebo arm were converted to the voclosporin
treatment arm.
    The primary endpoint of the ESSENCE trial was superiority in the
proportion of patients achieving a score of "clear" or "almost clear" in the
Static Physician's Global Assessment (SPGA) score. Secondary endpoints
included, among others, non-inferiority of voclosporin compared to
cyclosporine in the proportion of patients achieving a "clear" or "almost
clear" in SPGA and superiority in de novo hypertriglyceridemia, de novo
hypertension and renal function.

    
    About Isotechnika
    -----------------
    

    Edmonton-based Isotechnika Inc. is a 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 have been completed and data is being collected and analyzed.
Our partner, Lux BioSciences, Inc., has recently completed three separate
Phase 2/3 pivotal trials investigating voclosporin (referred to as LUVENIQ(TM)
by Lux) for the treatment of uveitis. In addition to the uveitis trials, Lux
BioSciences Inc. has also commenced a Phase 1 trial using their proprietary
voclosporin ophthalmic solution (LX214) as a candidate for dry eye syndrome.
Voclosporin has also entered First-in-Man trials as the drug utilized in the
CINATRA(TM) Drug Coated Coronary Stent system developed by the Company's
partner, Atrium Medical Corporation.
    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 or www.SEDAR.com.

    
    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.

    %SEDAR: 00010508E




For further information:

For further information: Dr. Robert Foster, President & CEO, Isotechnika
Inc., Phone: (780) 487-1600 Ext. 247, Fax: 780-484-4105, Email:
rfoster@isotechnika.com; Dr. Launa Aspeslet, Chief Operating Officer,
Isotechnika Inc., Phone: (780) 487-1600 Ext. 225, Email:
laspeslet@isotechnika.com

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ISOTECHNIKA PHARMA INC.

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