This is from the AOL board on LXR -
CALIFORNIA PACIFIC MEDICAL CENTER'S HEART SOLUTION NEARS FDA APPROVAL FOR CLINICAL TRIALS
Oct. 30, 1997 - (San Francisco) Dr. J. Donald Hill, Chairman of the Dept. of Cardiac Surgery at CPMC announced today that the U.S. FDA may grant an Investigational Device Exemption (IDE) as early as Nov. 1, 1997, for the heart preservation solution developed at CPMC and now owned by LXR Biotechnology, Inc., in Richmond, Ca. The approval would signal the launch of open labeled, randomized, pivotal clinical trials of the patented solution
HK-Cardiosol tm, at major heart transplant centers throughout the U.S. and Europe.
Cal. Pacific's heart transplantation program conducted the first and only clinical trials of an earlier version of HK-Cardiosol tm in 1990. The solution both extends the time a donor heart can be preserved outside the body from 4 hours to 12-18 hours and decreases the incidence and severity of rejection.
Results from that study showed that 5 years after transplantation, there was a 100% survival rate compared to a 69% survival rate nationally, and a 75-78% survival rate at CPMC, for heart transplant patients not receiving HK-Cardiosol tm. Extending the time a donor heart can be safely kept outside the body before reinplantation will significantly increase the pool of donor hearts available for the long list of recipients waiting.
The IDE trial to evaluate HK-Cardiosol tm for use in routine open heart surgery is planned for early 1998. There are approximately 850,000 open heart procedures and 4000 heart transplant procedures performed world wide each year.
"We developed the solution at CPMC. Successfully transferring the technology from research to private industry gives us the opportunity to make it available to the thousands of patients who may benefit from it," said Dr. Hill. "I'm excited about the impending FDA IDE permission to get going on our clinical trials to reprove the safety and efficacy of HK-Cardiosol tm. HK-Cardiosol tm worked, and now we want to use it more widely." |
