Nitric oxide (NO), is a simple gaseous free radical that plays a dual role in human health and disease. In small amounts, NO is an essential physiological regulator, playing important roles in blood pressure regulation, memory, and host defense. On the other hand, NO overproduction, which is a feature common to many medical problems and disorders, causes molecular damage that leads to disease-causing cellular dysfunction.
To address this dual role, Medinox is developing its proprietary NO neutralizers, a unique pharmaceutical technology that removes the excess pathology-causing NO while preserving the basal beneficial levels of NO. Our small-molecule NO neutralizers bind nitric oxide very tightly and with great specificity. The bound NO is thus inactivated and prevented from participating in pathology-causing reactions. Both injectable and orally-active NO neutralizers are under development. Targeted diseases and disorders include sepsis, ARDS and diabetes, among many others. Medinox's most advanced product, the injectable NO neutralizer NOX-100, which was shown to have an excellent safety profile in a recent human study. NOX-100 is now being evaluated in a multicenter Phase I/IIa septic shock study.
Non Steroidal Anti-Inflammatory Drugs (NSAIDs) are widely prescribed medicines for treating inflammation and pain. However, they can cause severe and sometimes fatal stomach and intestinal ulcers. To address the $10 billion NSAID market, Medinox is developing novel NSAIDs, which in animal studies deliver the proven therapeutic benefit of their parent NSAIDs, without the gastrointestinal side effects.
In December 2002, Medinox completed a Phase I safety trial of MX-1094 that was designed to evaluate the initial safety profile, tolerability and pharmacokinetics of MX-1094 in healthy volunteers. Because we observed a good safety profile in this study, we plan to advance development to a small-scale Phase II trial in Europe beginning in early 2004.
Medinox's researchers have created an orally-active compound, MX-1520, that improves the oxygen carrying properties of hemoglobin S (HbS), the mutant hemoglobin of sickle cell anemia. We have shown proof of concept for MX-1520 in an animal model of sickle cell anemia. MX-1520 has exciting prospects for success as a new prophylactic therapy for prevention of the vaso-occlusive episodes that characterize sickle cell anemia.