SAN DIEGO, March 8 /PRNewswire/ -- Medinox announces today that Dr. Monte Lai presented the data from the Company's Phase 1/2a clinical trial of NOX-100, a nitric oxide (NO) neutralizer, at the Sixth World Congress on Trauma, Inflammation, Shock and Sepsis in Munich, Germany on March 3, 2004.
Fifty-six patients suffering from severe septic shock (by SIRS criteria) were enrolled in the double-blind, placebo-controlled multi-center trial of NOX-100 which was completed in February 2004. Patients were centrally randomized to doses of NOX-100 or placebo and received all other standard supportive therapies considered appropriate by the clinical investigators at the 12 academic centers in the States.
The results of the trial show the hemodynamic response rates after 48 hours for the 53 evaluable patients were: for NOX-100 patients (by infusion dose/kg/hour received) 1mg-29% (2/7); 3mg-79% (11/14); 6mg-70% (7/10); and 12mg-63% (5/8). Placebo patients had a 50% (7/14) hemodymanic response rate. In the same patients, the rates of survival at 30 days for the NOX-100 groups were: 1mg-71%; 3mg-57%; 6mg-50%; and 12mg-63%. The 30-day survival rate in patients who received the saline placebo was 43%.
The analysis of clinical adverse events and adverse laboratory changes was done for all 56 patients and showed no clinically significant differences between the placebo group and the various NOX-100 groups. Only one serious adverse event (marked tachycardia and hypotension) was considered to be related to the study therapy and that event occurred in a patient who received the saline placebo.
The results of this trial in patients with severe septic shock indicate a beneficial effect for NOX-100 with a possible survival advantage and an excellent safety profile. Phase 3 trials in this patient population are planned.
NOX-100, also known as Norathiol(TM), is the first in a series of proprietary small molecule anti-nitric oxide agents that Medinox has created. These NO neutralizers represent a novel therapeutic approach by removing the dangerously overproduced NO in inflamed tissues while sparing the low levels of NO in normal tissues that are vitally necessary for many ongoing organ functions.
"We are encouraged by both the positive effects we observed in this trial in patients with septic shock and also by the apparent lack of adverse events related to NOX-100," said Dr. Lai, President and CEO of Medinox. He added, "It is clearly very important that any therapy for septic shock must not cause significant adverse effects in patients who are already critically ill and NOX-100 has met that test in our trials. We look forward to confirming the efficacy and the safety of NOX-100 in the Phase 3 trials that we are planning now."
Medinox is a leader in anti-NO therapeutics and is developing a broad technology platform to address a wide variety of unmet medical needs including septic shock, acute respiratory distress syndrome (including SARS) and hemorrhagic shock. In addition to its NO technology, Medinox is also developing new and safer NSAID prodrugs and MX-1520, a unique therapeutic for sickle cell anemia. For information about Medinox and its products, please visit the Company's website at http://www.medinox.com/, or contact Monte Lai, Ph.D.,President & CEO of Medinox, Inc., at 858-793-4820, or by email at firstname.lastname@example.org.