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

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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

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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      -30-  /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/  
 

Posted: April 2009

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