Monday March 11, 6:19 pm Eastern Time
WSJ:SangStat Kidney-Transplant Study Ends On Good Results
By: David P. Hamilton, Of The Wall Street Journal
FREMONT, Calif. -(Dow Jones)- SangStat Medical Corp. (SANG) said positive interim results led researchers to call an early halt to a study comparing the company's Thymoglobulin against a Novartis AG (NOV)ADVERTISEMENT
drug, Simulect, in kidney- transplant patients.
The clinical trial, conducted at several centers in the U.S. and Europe, was designed to measure the effectiveness of the two drugs in preventing rejection or "delayed function" of the transplanted organs in high-risk patients. SangStat funded the study.
Daniel Brennan, a transplant specialist at Washington University in St. Louis , who oversaw the trial, said an interim analysis of the results for 212 patients showed that those receiving Simulect were 2.5 times more likely to suffer " acute" kidney rejection than those who received Thymoglobulin.
(This report and related background will be available at the Journal's Web site, WSJ.com.)
Novartis officials couldn't be reached for comment.
Dr. Brennan added that the acute-rejection results were statistically significant, and said that neither drug was associated with an increase in other side effects. Neither the company nor Dr. Brennan would release further details of the interim analysis, saying that the researchers preferred to present their findings at a scientific meeting next month.
As a result of those findings, an independent data-monitoring board voted to end the trial early on ethical grounds, reasoning that the benefit of treatment with Thymoglobulin was clear. Dr. Brennan was one of the panel's five members. He has served as a paid consultant to SangStat but owns no stock in the company.
The SangStat drug, technically known as a rabbit anti-thymocyte globulin, is currently approved in the U.S. only for treatment of kidney-transplant rejection, not for use in prevention of rejection. SangStat Chairman and Chief Executive Jean-Jacques Bienaime said the results were "very exciting" and added that the company hopes it can now "grab part of the market" held by Simulect, known generically as basiliximab.
Bienaime estimated that Simulect sales in the U.S. are more than $25 million a year. He added that since Thymoglobulin costs more than twice what Simulect does, the "equivalent" opportunity for his company's drug is $50 million in annual U.S. sales.
-By David P. Hamilton, The Wall Street Journal, 415-765-6116 |
