Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.US-based La Jolla Pharmaceutical Company (LJPC) has completed patient enrollment in GCS-100-CS-4003 (4003 study), the company's Phase II extension trial of GCS-100 for the treatment of chronic kidney disease (CKD).
Subscribe to our email newsletter
The trial is designed to evaluate the long-term safety and efficacy of GCS-100 in patients who completed the initial 12-week Phase II study (GCS-100-CS-4002).
In the 4003 extension trial, about 93 patients were enrolled across five sites and initial data is expected late in 2014.
La Jolla Pharmaceutical Company chief executive officer George Tidmarsh said the company is happy to have completed enrollment and encouraged by the greater than 80% participation of eligible patients.
"Chronic kidney disease affects nearly 50 million people in the United States. We believe GCS-100 can be an effective treatment option for those suffering from CKDm," Tidmarsh said.
University of Texas Health Science Center clinical associate professor of Medicine Pablo Pergola said the centre has been impressed with how many patients were willing to continue participation in the extension study and how well they continue to tolerate GCS-100.
"We look forward to seeing if patients on this ongoing trial experience similar or greater improvement in kidney function with longer term treatment," Pergola said.
The 4003 extension trial was designed to enroll CKD patients who completed the 4002 study and they were randomized in a 1:1 ratio to either treatment with 1.5 mg/m2 GCS-100 or 30 mg/m2 GCS-100.
All doses of drug will be administered intravenously once weekly for about eight consecutive weeks with a four-week follow-up period and then once a month for a total of one year.
Primary objective of the Phase II extension trial is to determine the safety and tolerability of extended dosing with GCS-100, while secondary objective is to determine the efficacy as measured by eGFR of GCS-100 administered for eight-weeks relative to the effect of eight-weeks of treatment for the same patient on the GCS-100-CS-4002 study including those who were on placebo.
Image: Initial data from La Jolla’s Phase II extension trial of CKD drug GCS-100 is expected to be announced late in 2014. Photo: courtesy of Grant Cochrane/ freedigitalphotos.net