SAN DIEGO, CA -- (Marketwired) -- 05/29/13 -- La Jolla Pharmaceutical Company (OTCBB: LJPC) ("La Jolla" and "Company"), a leader in the development of therapeutics targeting technology/galectins/">galectin proteins, released data today from the Phase 1 (Part A) portion of the Phase 1/2 clinical trial of GCS-100 in patients with chronic kidney disease ("CKD"). Based on the positive results of this study, the Company expects to start a randomized, Phase 2a clinical trial next month.
The completed Phase 1 study was an open-label, multi-center dose escalation study of GCS-100 in patients with Stage 3b and 4 CKD. No serious adverse events were observed, and there were no adverse changes in laboratory measures. A small number of patients, 4 of the 29, experienced at least one adverse event, including mild hives and itching or muscle cramping. Although the maximum tolerated dose according to the protocol was not reached, moderate to severe cramping in one patient lead to the termination of the dose escalation.
Baseline serum galectin-3 levels inversely correlated with renal function as measured by estimated glomerular filtration rate ("eGFR"), with higher levels of galectin-3 found in those patients with worse renal function (lower eGFR). A statistically significant post-dose reduction of serum galectin-3 was also observed at the higher doses of GCS-100. This reduction in serum galectin-3 was sustained until Day 7 when a rebound to levels above baseline was observed. This rebound may be due to release of galectin-3 from cellular receptors, including those found in kidney tissue.
"The reduction in serum galectin-3 concentration after a single dose of GCS-100 is a good indication that we are successfully having an impact on the target biomarker, a molecule we know correlates with organ fibrosis," said George Tidmarsh, M.D., Ph.D., President and Chief Executive Officer of La Jolla. "We are very pleased with the quick progress made enrolling the Phase 1 portion of the trial and believe this underscores the significant unmet medical need of CKD patients."
Based upon the favorable safety profile and encouraging galectin-3 results, the company plans to close this study and initiate a randomized Phase 2a study in early June. Details of this study will be presented shortly.
About The Phase 1/2 Clinical Study
Enrollment was open to patients at least 18 years of age with moderately severe to severe renal impairment and treatment comprised a single dose of GCS-100 from 0.5 to 30 mg/m2 with a 2 week follow-up in cohorts of 3-6 patients. The primary objective of the study was to evaluate the safety of GCS-100. Secondary study objectives included evaluating serum levels of galectin-3, renal function, and other markers of disease activity in CKD. The study consisted of 2 Parts; Phase 1 (Part A) and Phase 2 (Part B). The company plans to close this study before enrolling Part B and instead, start a Phase 2a randomized clinical trial in the same patient population.
Most Popular Stories
- NSA Defends Global Cellphone Tracking Legality
- Ad Counts Rise in 2013 for Hispanic Magazines
- Networks Vie for U.S. Hispanic TV Viewers
- Apple Wants Samsung to Pay $22M for Patent Dispute Legal Bills
- Starbucks Gets Grinchy; No Gingerbread Lattes for Tampa Customers
- Apple Paid Its Lawyers More Than $60MM to Defeat Samsung in Court
- Economic Bright Spots Not a Sure Boost for President Obama
- Jobs Report Brings Cheer As Unemployment Drops to Five-year Low
- Top Websites for U.S. Hispanics
- US Consumer Borrowing Rose $18.2B in Oct.