Medinox, Fuso Collaborate on Nitric Oxide Neutralizing Sepsis Drug
Other terms include purchase of Medinox stock by Fuso and the possibility of pre-commercialization payments from Fuso, including an up-front payment and milestones. Medinox will retain manufacturing rights to NOX-100 (I.V.) and will supply the product to Fuso for a royalty on net sales.
The bane of hospital patients, sepsis is a systemic inflammatory response to bacterial infection, shock, burns, or poisoning. Nitric oxide, which is overproduced during sepsis, is what makes sepsis so dangerous. This simple chemical, a vasodilator, dramatically lowers blood pressure, making it difficult for the circulatory system to provide blood to vital organs. Affecting more than 700,000 Americans each year and causing in excess of 100,000 deaths, sepsis is the 13th-leading cause of mortality in the United States.
Other Indications
Since late September 1999, Medinox has been conducting a Phase I/II clinical trial at the University of California, San Diego Medical Center to evaluate how NOX-100 (I.V.) might alleviate intradialytic hypotension (serious, transient low blood pressure), the leading adverse event in hemodialysis. Numerous studies have implicated excessive nitric oxide, a key biological signaling molecule, with this condition. Medinox will also evaluate NOX-100 (I.V.) for sepsis in a US Phase I/II clinical trial to begin later this year.
Solid Science
Nitric oxide's role in causing disease was affirmed by the 1998 Nobel Prize in medicine, awarded to three American researchers for their contributions linking the molecule do cardiovascular function. Because nitric oxide overproduction is common to many diseases, drug companies are exploring how to regulate the biosynthesis of this small but important molecule. Most efforts have focused inhibitors of nitric oxide synthases (NOS), enzymes that synthesize nitric oxide. Thus far these approaches have been unsuccessful because NOS inhibitors are too good—they eliminate even trace amounts of nitric oxide required for blood pressure regulation, memory neurotransmission, and host defense.
Medinox's strategy, using small-molecule drugs dubbed "NOX" (not to be confused with the general formula for oxides of nitrogen), which mop up excess nitric oxide while preserving basal levels needed for normal functioning. Since NOX compounds do not affect NOS activity and do not remove all nitric oxide molecules, they do not result in hypertension and similar side effects that occur with NOS inhibitors.
NOX compounds bind excess nitric oxide, preventing this tiny signalling molecule from interacting with other biomolecules. Once bound, nitric oxide is inactivated and unable to cause oxidative damage.
The Companies
Medinox's chief business is small-molecule nitric oxide neutralizing drugs, under investigation for treating intradialytic hypotension, hemorrhagic and septic shock, and complications from heart bypass surgery. Medinox is also looking at new non-steroidal anti-inflammatory drugs with improved gastrointestinal side-effect profiles and a new therapeutic for sickle cell anemia.
Fuso Pharmaceutical Industries is a leading manufacturer and supplier of dialysate for artificial kidneys and transfusion solutions in Japan. Fuso also manufactures and supplies injectable solutions and pharmaceuticals, and markets medical devices and portable blood analyzers. Fuso's 1999 sales amounted to 45 billion Yen.
For more information: Monte Lai, President and CEO, Medinox Inc., 11575 Sorrento Valley Rd., Suite 201, San Diego, CA 92121. Tel: 858-793-4820. Fax: 858-793-4823.
By Angelo DePalma