Monday July 9, 8:06 am Eastern Time
Press Release
SOURCE: Medinox, Inc.
Medinox Initiates Multicenter Phase I/IIa Trial of
NOX-100 In Patients With Sepsis
SAN DIEGO, July 9 /PRNewswire/ -- Medinox, Inc. announced today the start of a Phase
I/IIa clinical trial, designed to evaluate the safety, tolerability, and preliminary efficacy of
NOX-100 in sepsis patients. The trial is being conducted at Stanford University and at the
University of Pittsburgh Medical Center and will take approximately one year to complete.
Millions of people are at risk for sepsis. Each year in the US alone, sepsis causes the
hospitalizations of over 500,000 people and the death of 100,000, making it the 13th leading
cause of death in the US. A US survey estimates that sepsis occurs in 2 cases per 100
hospital admissions.
Sepsis can arise from a number of causes including bacterial infections as well as from
non-infectious causes such as hemorrhagic shock, traumatic injury, burns, ischemia, and the
inhalation of toxic substances. These conditions can all lead to the overproduction of nitric
oxide (NO), a powerful signaling molecule that dilates blood vessels. Too much NO
production can result in very low blood pressure and decreased blood flow to vital organs.
When the circulation cannot provide enough blood to vital organs, this can result in multiple
organ failure and death.
``Sepsis is clearly a major health problem, with a high mortality rate despite currently
approved therapies, which emphasizes the major need for novel approaches such as
NOX-100,'' said Dr. Peter Linden, an Associate Professor of Medicine & Anesthesiology at
the University of Pittsburgh Medical Center and a principal investigator in this trial.
The overproduction of NO can also result in bacterial translocation (BT) -- the passage of
microbes from the intestines into the bloodstream -- which can cause sepsis. BT is a
common complication of surgery. By blocking the excess NO produced during sepsis,
NOX-100 can stop the potentially lethal ``chain reaction'' of BT before it starts.
Medinox's President & CEO, Dr. Monte Lai commented, ``Based on our earlier animal
models, in which NOX-100 demonstrated convincing proof of concept as a potential sepsis
therapy, we believe that this drug may give us the opportunity to meet the great clinical need
for a safe and effective therapeutic that could help millions.''
``We are very excited and optimistic about moving forward into the next stage of development of this promising new
compound,'' remarked Dr. Ronald G. Pearl, Chairman and Professor of Anesthesia at Stanford University and principal
investigator in the trial, ``the continuing high mortality of septic shock represents a major opportunity for NOX-100 to address
this unmet medical need.''
NOX-100, also known as Norathiol, is the first in a series of Medinox's proprietary small molecule nitric oxide (NO)-blocking
agents that are designed to bind and inactivate the excessive amounts of NO that are produced during inflammatory disease
conditions. NO blockers represent a truly novel therapeutic technology to address the overproduction of NO with its ability to
block and remove excess NO yet spare the low levels of this vital molecule that are also required for important body functions.
Medinox is the leader in NO-blocking therapeutics and is developing a broad technology platform to address a wide variety of
unmet medical needs including intradialytic hypotension, acute respiratory distress syndrome (ARDS), hemorrhagic shock,
cardiopulmonary bypass surgery, diabetes, and other chronic inflammatory diseases. In addition to its NO blocker technology,
Medinox is also developing new and safer NSAID prodrugs and MX-1520, a new therapeutic for sickle cell anemia. For
information on Medinox, please visit the company's website at www.medinox.com.
For further information, please contact Monte Lai, Ph.D., President & CEO of Medinox, Inc., 858-793-4820,
cslai@medinox.com.
SOURCE: Medinox, Inc. |
