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