EDMONTON, March 31 /CNW/ - Isotechnika Inc. announced today that an
independent data monitoring committee (DMC) has met and reviewed the interim
data from the ongoing Phase 3 psoriasis (ESSENCE) trial. The review included
24-week data from approximately 50% of the patients enrolled in the trial.
Based on their review of the safety and efficacy data, the DMC has not raised
any concerns that would require a change to the original study design.
The first patient was enrolled in the ESSENCE trial on December 3, 2006.
On July 20, 2007, the Company completed patient recruitment at 642 patients.
The patient population is composed of 295 patients from Germany, 116 from
Poland and 231 from Canada. The trial is currently being performed at a total
of 50 centers.
"The role of the DMC is to ensure the safety of the patients
participating in this trial," commented Dr. Foster, Isotechnika's Chairman &
Chief Executive Officer. "While efficacy can be determined as early as 12
weeks, the trial has been designed to remain blinded for the entire 60 week
duration so that longer-term safety data remains unbiased. The result of the
review was as expected and is very encouraging."
European/Canadian Phase 3 Psoriasis Trial Design
The ESSENCE trial is being conducted as a randomized, orally
administrated placebo and cyclosporine-controlled study with patients
receiving voclosporin (0.4 mg/kg twice daily), patients receiving cyclosporine
(1.5 mg/kg twice daily) and patients receiving placebo in a 3:1:1 ratio for 24
weeks. Patients enrolled in the placebo group will be converted to the
voclosporin arm following the first 12 weeks of treatment.
Upon the Company receiving regulatory approval for an extension to this
trial, patients who had not yet finished the 24 week portion of the trial were
given the opportunity to remain on therapy for an additional 36 weeks - making
the total length of treatment 60 weeks for these patients.
Successful completion of the trial will be determined by the primary
endpoint of superiority in the proportion of patients achieving a score of
"clear" or "almost clear" in the Static Physician's Global Assessment ("SPGA")
score at 12 weeks in the voclosporin treatment group compared to placebo
control. Secondary endpoints include, amongst others, non-inferiority of
voclosporin compared to the cyclosporine control arm in the proportion of
patients achieving a score of "clear" or "almost clear" in the SPGA score at
12 weeks and a 75% reduction in the PASI score.
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 exceeds $2 billion annually in sales for
calcineurin inhibitors such as voclosporin.
Isotechnika Inc. is a publicly traded company on the Toronto Stock
Exchange under the symbol "ISA". More information on Isotechnika can be found
Partnerships with Isotechnika Inc.
- Roche retains an option to continue development of the transplant
indications based on the successful completion of the ongoing Phase
2b kidney transplant trial.
- Atrium Medical Corporation has exclusive worldwide licensing
agreement for use of voclosporin and TAFA93 with drug eluting devices
for non-systemic treatment of vascular, cardiovascular, target vessel
and tissue disorders.
- Lux Biosciences Inc. was granted worldwide rights to develop and
commercialize voclosporin for the treatment and prophylaxis of all
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.
For further information:
For further information: Dr. Robert Foster, Chairman & CEO, Isotechnika
Inc., Phone: (780) 487-1600 Ext. 247, Fax: (780) 484-4105, Email:
firstname.lastname@example.org; Stephanie Gillis-Paulgaard, Director, Corporate
Communications, Isotechnika Inc., Phone: (780) 487-1600 Ext. 243, Fax: (780)
484-4105, E-mail: email@example.com