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 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.
About The Phase 2a Clinical Study
The Phase 2a study is designed to enroll approximately 117 subjects, at least 18 years of age, with Stage 3b or 4 CKD. Subjects will be randomly assigned 1:1:1 to treatment with placebo, 1.5 mg/m2 GCS-100 or 30 mg/m2 GCS-100. In addition, randomization will be stratified into two groups according to baseline renal function as defined by eGFR values of 15-29 and 30-44 mL/min/1.73m2, respectively. Once randomized, subjects will receive eight consecutive weekly doses of their assigned treatment with a follow-up four weeks after treatment.
About The Phase 1/2 Clinical Study
Enrollment of the Phase 1 study 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 closed this study before enrolling Part B and instead, started a Phase 2a randomized clinical trial in the same patient population.
About Chronic Kidney Disease
Chronic kidney disease ("CKD") currently affects 14% of Americans or approximately 49 million people. The United States Renal Data System, 2012 Annual Data Report, states that in 2010, costs for CKD reached $41 billion for Medicare alone. Overall per person per year costs for CKD were estimated at $22,323 for Medicare patients of age 65 and older and $13,395 for patients of age 50-64. Patients with CKD may progress to end-stage renal disease ("ESRD"). According to the National Institute of Diabetes and Digestive and Kidney Diseases as of 2008, there were 547,982 individuals in the US under treatment for ESRD and 88,630 deaths per year from ESRD.
GCS-100 is a complex polysaccharide that has the ability to bind to and block the effects of galectin-3. Galectin-3 is a soluble protein, over-expression of which has been implicated in a number of human diseases including cancer and chronic organ failure. The unique ability of GCS-100 to bind and sequester galectin-3 makes it an ideal candidate to prevent and treat diseases in which galectin-3 plays an important role.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is a biopharmaceutical company dedicated to the development of medical treatments that significantly improve outcomes in patients with life-threatening diseases. GCS-100, the Company's lead product candidate, is a first-in-class inhibitor of galectin-3, a novel molecular target implicated in chronic organ failure and cancer. For more information on the Company please visit http://www.ljpc.com.
Forward Looking Statement Safe Harbor
This document contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements relate to future events or our future results of operations. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause actual results to be materially different from these forward-looking statements. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. Certain of these risks, uncertainties, and other factors are described in greater detail in the Company's filings from time to time with the U.S. Securities and Exchange Commission ("SEC"), all of which are available free of charge on the SEC's web site http://www.sec.gov. These risks include, but are not limited to, risks relating to the development of GCS-100 and LJPC-501, the success and timing of future preclinical and clinical studies of this compound, and potential indications for which GCS-100 and LJPC-501 may be developed. Subsequent written and oral forward-looking statements attributable to the Company or to persons acting on its behalf are expressly qualified in their entirety by the cautionary statements set forth in the Company's reports filed with the SEC. The Company expressly disclaims any intent to update any forward-looking statements.
George F. Tidmarsh, M.D., Ph.D.
President & Chief Executive Officer
La Jolla Pharmaceutical Company
Phone: (858) 207-4264
Chester S. Zygmont, III
Director of Finance
La Jolla Pharmaceutical Company
Phone: (858) 207-4262
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