SAN FRANCISCO, Nov. 2, 2007 (PRIME NEWSWIRE) -- In the first two proof-of-concept studies in humans, CorMedix Inc. has shown that deferiprone -- an iron-trapping drug -- could become a major new therapy to slow the progression of chronic kidney disease (CKD) and its metabolic and cardiovascular complications.
"These studies raise the hope of providing an exciting new treatment for a disease that afflicts an estimated 20 million adults in the U.S.," said Sudhir V. Shah, M.D., F.A.C.P., Professor of Medicine and Director, Division of Nephrology, UAMS College of Medicine, Little Rock, Arkansas.
Dr. Shah is a world-renowned expert in iron-mediated oxidative stress. CorMedix, a cardiorenal-focused biopharmaceutical company headquartered near New York City, announced the results of its two deferiprone studies (in diabetic nephropathy and glomerulonephritis) at the 40th Annual Meeting of the American Society of Nephrology (ASN) in San Francisco, November 1-4.
"In earlier studies with biopsied tissue and lab animals, we demonstrated that a certain kind of iron can aggravate CKD by catalyzing free-radical reactions that put oxidative stress on cardiorenal systems," Dr. Shah said. "And we learned that patients with diabetic renal disease have abnormally high levels of catalytic iron - often called 'labile' or 'toxic' iron - in their urine. But we needed to clarify the significance of this finding."
To test deferiprone's safety and efficacy, "we conducted the first experiment with a patient-friendly, oral formulation," Dr. Shah said. "At the Baroda Medical Center in India, we gave each of 38 diabetic nephropathy patients a daily 50 mg/Kg dose of deferiprone. The drug binds excess iron at the molecular level, allowing it to be excreted. Throughout the nine-month study, the patients' mean albumin-to-creatinine ratios declined steadily. Kidney function remained stable. No significant safety issues arose."
The second proof-of-concept study involved 14 patients with biopsy-proven glomerulonephritis, who also received a 50 mg/Kg daily dose of deferiprone. At the beginning of the six-month study, the patients' total urinary protein levels were abnormally high; by the end of the study, these levels had significantly decreased.
Dr. Shah explained that deferiprone's iron-scavenging characteristics set it apart from other antioxidants: "Traditional antioxidants remove oxidative radicals only after they have been formed. But deferiprone is a powerful upstream inhibitor. It actually halts the process that produces reactive oxygen species."
As a disease, CKD "is not only epidemic in scope, but widely misunderstood," Dr. Shah said. "An asymptomatic 'silent killer,' it more likely leads to an early death from heart disease than to renal failure requiring dialysis. But now that we have conducted these two proof-of-concept studies, we are hopeful that future randomized, double-blind trials - with careful dosing, and close monitoring of safety issues - will yield an exciting new therapy for slowing the progression of CKD."
Principal investigator for the two CorMedix proof-of-concept studies was Mohan M. Rajapurkar, M.D., of the Muljibhai Patel Urological Hospital, Madiad, Gujarat, India. Dr. Rajapurkar will present the CorMedix proof-of-concept study (Poster SA-FC108) "Treatment of Patients with Glomerulonephritis with an Oral Iron Chelator" at 4:45 p.m., Saturday, November 3 as part of the ASN Clinical Nephrology Conference titled New Management Strategies and Treatments in Glomerulonephritis.
About CorMedix
A biopharmaceutical company based in Summit, NJ (20 miles from New York City), CorMedix focuses on treating cardiorenal diseases. Its signature approach is "Treating the Kidney to Treat the Heart." CorMedix has a Phase III development program supported by an SPA agreement with the FDA for a single pivotal trial of deferiprone, a unique iron chelator that concentrates in an active form in the kidney. CorMedix's DEFEND-AKI Study will be the largest multi-center, multi-national study of actual clinical outcomes in patients who are at the highest risk for contrast-induced nephropathy. The acronym "DEFEND-AKI" stands for: "DEFeriprone for the Reduction of ENDpoints Associated with Acute Kidney Injury Following the Administration of Iodinated Contrast." For more information, visit CorMedix's Web site at www.cormedix.com.