SAN DIEGO, Calif.— La Jolla Pharmaceutical Company announced today that the FDA Division of Cardiovascular and Renal Products agreed that the Company has sufficient data to support a short-term clinical trial of GCS-100 in patients with chronic kidney disease (CKD) or end-stage renal disease (ESRD).
"Having FDA accept our data in support of a clinical trial in patients with CKD is a major milestone for La Jolla," said George Tidmarsh, MD PhD, chief executive officer of La Jolla. "We are pleased with our progress and look forward to initiating the study."
"The scientific rational supporting the potential role of GCS-100 in organ failure is very strong," Tidmarsh added. "This kidney disease program will complement our program with GCS-100 in cancer immune modulation."
The National Institute of Diabetes and Digestive and Kidney Diseases estimated that in 2008, 20 million U.S. adults suffered from CKD, 547,982 were under treatment for ESRD resulting in 88,630 deaths per year. In total, $40 billion was spent in 2008 in the U.S. on ESRD. To date, there are no FDA approved therapies for ESRD.
Initiation of the Phase 1 trial is dependent on the company first filing an Investigational New Drug application (IND) with the FDA. The study cannot begin before that filing is accepted. La Jolla plans to file the IND this year.