Keryx Biopharmaceuticals Inc announced that the Collaborative Study Group (CSG), the largest standing renal clinical trial group comprised of academic and tertiary nephrology care centers, will conduct Keryx's US-based Phase II/III clinical program for KRX-101 (sulodexide) for the treatment of diabetic nephropathy. It is anticipated that the KRX-101 clinical program will commence by the late third quarter or early fourth quarter of 2003.
KRX-101 is a first-in-class oral heparinoid compound that has been studied extensively in Europe and is currently being marketed in select European, Asian and South American markets by the Company's licensor for certain cardiovascular indications. More than 20 studies have been published in leading medical journals assessing the safety and efficacy of KRX-101 in diabetic nephropathy and other vascular indications. Most recently, KRX-101 demonstrated significant efficacy in treating diabetic nephropathy in a randomized, placebo-controlled, 223-patient Phase II clinical trial (the DiNAS Study).
"We believe this is an important validation of the potential for KRX-101," said Michael S. Weiss, Keryx's Chairman and CEO. "The CSG is highly selective in the drug candidates that it works with and has an outstanding track-record of conducting high quality, medically important clinical trials in the field of renal care and diabetic nephropathy. In fact, each of their last 3 major clinical trials led to product approvals, including the recent approval of Bristol-Myers Squibb's and Sanofi's drug, irbesartan (Avapro), an angiotensin receptor blocker (ARB) for diabetic nephropathy."
Weiss continued, "We are very excited to place our Phase II/III clinical program for KRX-101 in the hands of these leading renal care and diabetes specialists so that it may finally begin to benefit the millions of patients that continue to suffer from this disease."