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Initial Results of Pyridorin Phase II Trials Suggest Safety, Efficacy
Pyridorin, a small molecule that uniquely inhibits the formation of harmful advanced glycation end-products (AGEs), has been granted Fast Track status by the FDA and has recently completed Phase II clinical trials for the treatment of diabetic kidney disease. AGEs are widely held to be a cause of diabetic complications such as kidney disease (nephropathy), blindness (retinopathy), and nerve damage (neuropathy).
Diabetic nephropathy occurs in approximately 30-40% of patients with type 1 or type 2 diabetes and is currently the leading cause of end stage renal disease in the United States and Europe. Despite the broad use of currently available therapeutic agents, the prevalence of diabetic nephropathy continues to increase at an alarming rate.
In his presentation, Dr. Robert J. Schotzinger, BioStratum's President & Chief Executive Officer, provided initial findings from studies PYR-205 and PYR-207, two six-month Phase IIb trials of Pyridorin. The multinational, double-blind studies involved a total of 84 patients with either type 1 or type 2 diabetes and either mild-to-moderate (PYR-205) or moderate-to-severe (PYR-207) diabetic nephropathy. Patients were randomized to receive either Pyridorin or placebo in addition to standard of care therapy for diabetic nephropathy. The trial results suggest that Pyridorin may be safe and effective in the treatment of diabetic nephropathy:
Pyridorin was safe and well tolerated.
The rate of rise in serum creatinine, a well accepted marker for the progression of diabetic nephropathy, was decreased in a statistically significant manner in patients receiving Pyridorin compared to those receiving placebo.
Urinary TGF-ß1 levels were dramatically decreased in patients receiving Pyridorin compared to those receiving placebo. TGF-ß1 is a cytokine that has been implicated in the development and progression of diabetic kidney disease.
"The results from these Phase IIb clinical trials are extremely encouraging and support the results from study PYR-206 reported last year. With three completed Phase II studies in-hand, BioStratum has now compiled a compelling package of safety and efficacy data which supports the initiation of the Pyridorin Phase III program," said Dr. Schotzinger. "As Pyridorin moves into the later stages of clinical development, we are actively seeking to acquire other clinical-stage drug candidates for the treatment of diabetic complications to further strengthen our pipeline," added Dr. Schotzinger.
A detailed presentation of the PYR-205 and PYR-207 study results is anticipated for the American Diabetes Association's 64th Annual Scientific Sessions to be held in Orlando, Florida from June 4-8, 2004.
Source: BioStratum Incorporated