SAN DIEGO, CA -- (Marketwired) -- 06/24/13 -- La Jolla Pharmaceutical Company (OTCQB: LJPC) ("La Jolla" and "Company"), a leader in the development of therapeutics targeting technology/galectins/">galectin proteins, announced today that a recent online publication of the Journal of the American Society of Nephrology ("JASN") on June 13, 2013, by Conall M. O'Seaghdha and colleagues at the National Heart, Lung, and Blood Institute of the National Institute of Health ("NIH") independently confirms data La Jolla released on May 29, 2013. The data from La Jolla showed a statistically significant inverse correlation between galectin-3 and estimated glomerular filtration rate ("eGFR") in the Phase 1 clinical study of GCS-100 in chronic kidney disease ("CKD").
In the JASN article O'Seaghdha and colleagues studied 2,450 individuals who had normal kidney function at baseline and were followed up 10 years later. At baseline, galectin-3 inversely correlated with eGFR, and higher levels of galectin-3 were associated with increased age, higher body mass index, and lower high density lipoprotein. At the 10-year follow-up visit, the average eGFR ranged from 73.3+/-16 to 84.6+/-14 mL/min/1.73m2, representing CKD progression to Stages 1, 2, and 3a. Of the participants, 241 (9.2%) had a rapid decline in eGFR (decrease ≥3 mL/min/1.73m2 per year) and 277 (11.3%) developed incident CKD. Increasing levels of galectin-3 were associated with an increased risk of both eGFR decline (adjusted odds ratio [OR]: 1.38; p
Tissue fibrosis is a significant driver of CKD, and galectin-3 plays a role in mediating fibrosis in the kidney, as well as other organs. Galectin-3 also contributes to induction of inflammation, which is associated with CKD progression. The fact that baseline galectin-3 was associated with CKD development at early stages of disease in this study suggests galectin-3 may represent a novel biomarker for assessment of CKD risk and highlights the potential role of galectin-3 in the pathogenesis of CKD.
"We are pleased that the data from the NIH study confirms findings from our Phase 1 study, showing higher galectin-3 levels are associated with declining renal function," commented George Tidmarsh, MD, PhD, President and CEO of La Jolla. "Furthermore, the data supports our Phase 2a trial using GCS-100 to inhibit galectin-3 in CKD patients, and we look forward to obtaining the results from this study."
La Jolla recently completed and announced the results of a Phase 1 study of GCS-100 in patients with Stage 3b and 4 CKD. The product candidate was found to be safe with no serious adverse events observed and no adverse changes in laboratory measures. Baseline serum galectin-3 levels inversely correlated with renal function as measured by 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.
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