SAN DIEGO, CA, May 30, 2002. Medinox, Inc. announced today the start of a Phase 1 clinical trial of NOX-700, an orally active nitric oxide (NO) blocking agent in development for diabetes mellitus. The trial is being conducted in The Netherlands and is scheduled for completion in Q4 of 2002.
The trial is a randomized, double blind, placebo-controlled, escalating single- and multiple- dose study and will evaluate subjects in two stages. Stage one will require approximately two months and will determine the initial safety profile, tolerability and pharmacokinetics of NOX-700 given as single and multiple oral doses for up to 14 days in healthy subjects. Stage two will require approximately two months and will determine the safety, tolerability, and pharmacokinetics of NOX-700 given as multiple oral doses for up to 14 days in Type 2 diabetic patients.
Currently, 17 million Americans suffer from diabetes, and each day approximately 2,200 others are diagnosed with the disease, making it the sixth leading cause of death in the US. Life-threatening complications associated with diabetes include heart disease, stroke, high blood pressure, blindness, kidney disease, among others.
"Diabetes is clearly a major health problem and represents a major unmet medical need. With the initiation of our NOX-700 clinical trial, Medinox is confirming its commitment to the development of a novel approach for treating the millions that suffer from diabetes," said Monte Lai, Medinox's President and CEO.
NOX-700 has shown excellent preclinical pharmacology. In animal models of Type 2 diabetes, treatment with NOX-700 resulted in a better control of blood glucose associated with the diabetic condition. NOX-700 has been well tolerated in long-term dosing in animal models, which suggests the compound's safety for chronic use.
About Medinox, Inc. Medinox is the leader in NO-blocking therapeutics and is developing a broad technology platform to treat a wide variety of unmet medical needs including, sepsis, diabetes, adult respiratory distress syndrome (ARDS), and arthritis. In addition to its NO blocker technology, Medinox is developing new and safer NSAIDs and new therapeutics for sickle cell anemia. Medinox is currently evaluating its injectable NO blocker, NOX-100, in a multicenter Phase 1/2a clinical trial for the sepsis indication which is scheduled for completion in Q4 2002.
For information on Medinox, please visit the company's website at www.medinox.com.