The pharmaceutical firm SangStat has announced positive preliminary results of a clinical trail in which stable kidney transplant recipients taking Sandimmune switched to Sang-35, SangStat’s proprietary cyclosporine.
The trial, conducted at the University of Cincinnati, was carried out in 42 patients ranging in age from 27 to 70 who had undergone kidney transplantation 10 months to 14 years before entering the trial.
Once the patients switched from Sandimmune to Sang-35, doses were adjusted to achieve equivalent drug exposures. The adjustments resulted in an average 12% decrease in the required dose of cyclosporine. Patients were followed for at least four months, and conversion was safely performed without acute rejection or any unexpected side effects, according to SangStat.
Sandimmune, the original formulation of cyclosporine, was introduced in the United States in 1983. Neoral, an improved formulation of cyclosporine, became available in 1995. While many patients continue to use Sandimmune, about 60% of U.S. transplant recipients previously on Sandimmune have converted to Neoral, according to SangStat. Sandimmune and Neoral are marketed by Novartis Ltd. The FDA is currently considering an application from SangStat for clearance to market Sang-35 as a Neoral bioequivalent.
M. Roy First, MD, the principal investigator of the University of Cincinnati study and a past president of the American Society of Transplant Physicians, said: "We’ve had a lot of experience with converting transplant patients from Sandimmune to Neoral. The results suggest that you can also easily convert patients, with few dose adjustments, from Sandimmune to SangStat’s cyclosporine, Sang-35."
For Your Information:
SangStat Medical Corporation
1505 Adams Drive, Menlo Park, CA 94025
605-328-0300 (phone); 650-328-8892 (fax)Full press release: http://biz.yahoo.com/bw/97/11/03/sang_y000_1.html
Please be aware that medical advice, diagnoses and physician references cannot be obtained from this site.