La Jolla completes patient dosing in Phase I portion of GCS-100 clinical trial - Clinical Trials Arena
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La Jolla completes patient dosing in Phase I portion of GCS-100 clinical trial

07 May 2013

La Jolla Pharmaceutical has treated the last patient in the Phase I (Part A) portion of its Phase I/II clinical trial of GCS-100 to treat chronic kidney disease (CKD).

La Jolla Pharmaceutical has treated the last patient in the Phase I (Part A) portion of its Phase I/II clinical trial of GCS-100 to treat chronic kidney disease (CKD).

GCS-100 is a first-in-class inhibitor of galectin-3, used for the treatment of chronic organ failure and cancer.

As part of the clinical study, a total of 29 patients with Stage 3b and 4 CKD were recruited and treated.

La Jolla is planning to release data from this portion of the clinical trial later this month.

"La Jolla is planning to release data from this portion of the clinical trial later this month."

La Jolla president and chief executive officer Dr George Tidmarsh said the company is pleased with the quick enrolment of the Phase I portion of the trial, and believes this highlights the significant unmet medical need of CKD patients.

"We are evaluating the data and hope to release the results shortly," Tidmarsh said.

The study’s primary endpoints include evaluating the safety of a single dose (Part A) and repeat doses (Part B) of GCS-100, while secondary endpoints include evaluating galectin-3 serum levels, renal function and other disease activity markers in CKD.

Open to patients aged 18 and over with moderately severe to severe renal impairment, the study model may be changed from time-to-time to comply with requests from the FDA, the governing Institutional Review Board, study investigators or at the company’s discretion.