Voclosporin Study Published in the American Journal of Transplantation
EDMONTON, Oct. 5, 2011 /CNW/ - Isotechnika Pharma Inc. (TSX: ISA) is proud to announce the publication of the PROMISE study in the American Journal of Transplantation (AJT), one of the most respected journals in transplant medicine.
The PROMISE study was a Phase 2b, 6-month, randomized, open-label study of three concentration-controlled groups of voclosporin (VCS), low, medium, and high, compared to tacrolimus (TAC) in 334 low-risk kidney transplantation recipients at 36 sites in the United States and 4 sites in Canada. The primary endpoint of the study was to demonstrate noninferiority of at least one of the three VCS groups in preventing acute rejection compared to TAC after kidney transplantation.
The primary investigator, and lead author of the study, was Dr. Stephan Busque from the Stanford University School of Medicine. As a dose ranging study, the Phase 2b trial was successful in meeting the primary endpoint demonstrating non-inferiority in biopsy proven acute rejection (BPAR) episodes in all three dose groups as compared to TAC control at six months. Overall, Dr. Busque and his co-authors concluded that VCS is as efficacious as TAC in preventing acute rejection, has similar renal function in the low and medium-exposure groups, and is potentially associated with a reduced incidence of new onset diabetes after transplant (NODAT). In terms of adverse events, diarrhea was more common with TAC, as was the persistence of neurological symptoms (tremors) beyond 3 months posttransplantation.
"This study opens the possibility that improving calcineurin inhibitors (CNIs) could be an easier way to achieve improvement in clinical outcomes. The problematic development of CNI alternatives also supports the merits of developing new CNIs such as voclosporin," commented Dr. Stephan Busque.
"The AJT is the highest impact journal in the field of transplantation, and we are very pleased to have voclosporin featured in such a prestigious publication. Calcineurin inhibitors (currently cyclosporine and TAC) remain the cornerstone of immunosuppressant therapy for transplant patients. NODAT is an important concern with TAC. The literature demonstrates that NODAT results in increased graft loss by 3 years, a 23% increase in patient death at 5 years, with an annual cost of $12,0001,2,3. We anticipate that our novel calcineurin inhibitor, voclosporin, will provide a significant benefit in this regard, as well as cause less diarrhea and tremors. Furthermore, the clear relationship between blood concentrations of voclosporin and clinical outcomes with voclosporin is another distinct advantage as it should enhance ease of dosing and monitoring for both physicians and patients," commented Dr. Robert Foster, CEO of Isotechnika.
About Isotechnika Pharma Inc.
Isotechnika Pharma Inc. is a biopharmaceutical company focused on the discovery and development of immunomodulating therapeutics designed to offer key safety advantages over currently available treatments. Its lead drug, voclosporin, is a calcineurin inhibitor, and is targeted at the estimated US$3.0 billion market for this class of immunosuppressants. Isotechnika Pharma Inc. trades on the Toronto Stock Exchange under the symbol "ISA". More information on Isotechnika Pharma can be found at www.isotechnika.com or www.sedar.com.
We seek Safe Harbour.
1 Patient Survival and Cardiovascular Risk After Kidney Transplantation: The Challenge of Diabetes, FG Cosio, AJT 2009
2 Jindal, RM et al. Impact and management of posttransplant diabetes mellitus. Transplantation 2000; 70:SS58.
3 Diabetes mellitus after renal transplantation: as deleterious as non-transplant associated diabetes? Miles AM et al Transplantation 1998 Feb 15;65(3):380-4
For further information:
Dr. Robert Foster
Mr. Robert Huizinga
President & CEO
Vice President, Clinical Affairs
Posted: October 2011