SAN DIEGO, CA -- (Marketwire) -- 04/16/12 -- La Jolla Pharmaceutical Company (OTCQB: LJPC) (PINKSHEETS: LJPC) today announced initial product development plans for advancing GCS-100, its first-in-class inhibitor of galectin-3.
On January 20, 2012, we announced the acquisition of GCS-100 from Solana Therapeutics, Inc. This acquisition makes us a leader in the development of therapeutics that target galectin-3, a protein that has been shown to play an important role in chronic organ failure and cancer. The Company believes that GCS-100 is the most advanced galectin-3 inhibitor in development and plans to initially focus its development activities in two areas of great unmet medical need: chronic kidney disease and cancer.
Chronic Kidney Disease: A Significant Unmet Medical Need
The developed world is suffering an epidemic of diabetes and hypertension, both of which cause kidney damage, chronic kidney disease and end-stage renal disease (ESRD). The National Institute of Diabetes and Digestive and Kidney Diseases estimates that 20 million United States adults suffered chronic kidney disease in 2008 [REF 1]. Of these 20 million people, 547,982 received treatment for ESRD and an estimated 88,630 died of ESRD. In total, a staggering $40 billion was spent in the United States on ESRD in 2008. ESRD leads to the need for dialysis and kidney transplantation. In 2008, 16,557 patients in the United States received a kidney transplant. Of these, 10,551 received a kidney from a non-living donor (cadaveric transplant). These transplants are at much higher risk of being rejected due to an attack by the patient's immune system. Despite improvements in therapies designed to suppress rejection by the recipient's immune system, 10% of patients receiving cadaveric transplants suffer acute rejection episodes which increases the risk of ultimate graft failure. In addition, the immunosuppressive therapies given to these patients increase the risk of infection and cancer due to sustained immune suppression.
The Role of Galectin-3 in Chronic Kidney Disease
Chronic organ failure involving the kidney, heart, liver or other organs is caused by fibrosis, or scar formation. Galectin-3 is normally found in most tissues at low concentration, but is up-regulated (increased) in response to injury. Several recent studies conducted by leading investigators have shown that increased circulating levels of galectin-3 are associated with poorer outcomes in patients with heart and kidney failure [REF 2, 3]. Furthermore, a number of preclinical studies have demonstrated a direct, causal role of galectin-3 in tissue fibrosis leading to kidney failure. Specifically, animals that have been genetically engineered to lack galectin-3 do not produce harmful scar formation after kidney injury or transplantation and have better kidney function. [REF 4, 5, 6].
GCS-100 for Chronic Kidney Disease
By inhibiting galectin-3, GCS-100 has the potential to delay or even reverse organ failure by preventing tissue fibrosis. GCS-100 has already been studied in more than 100 patients and has demonstrated an excellent side effect profile with mild-to-moderate, self-limiting rash as the principal side effect observed in clinical trials to date. We plan to initiate a clinical trial this year to study GCS-100 in cancer patients with renal (kidney) insufficiency. We will be evaluating several end points related to renal function, as well as looking at the effect of GCS-100 on plasma levels of galectin-3 and their relation to renal function.
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