Novoteris Investigator Receives Health Canada Clearance to Start Phase 2a Clinical Trial

Novoteris, LLC recently announced that the Therapeutic Products Directorate of Health Canada has cleared an investigator sponsored, pilot clinical trial application exploring the treatment of Non-Tuberculous Mycobacteria (NTM) with Novoteris’ Thiolanox inhaled nitric oxide gas, using its unique computerized trace-gas delivery system.

This single center open label trial will recruit 10 subjects to the Vancouver clinical site. This trial will enable the testing of nitric oxide in patients who have this debilitating disease and who are excluded from the Novoteris Phase 2 placebo controlled trial recruiting patients with Cystic Fibrosis (CF) in North America. Novoteris has demonstrated the broad-spectrum anti-microbial property of nitric oxide effectiveness against mycobacterium both with in-vitro studies and a 4.5 log decrease in sputum bacteria levels in two human subjects with Mycobacterium abscessus that were treated in its pilot clinical trial of patients with Cystic Fibrosis in Europe.

Gaseous nitric oxide’s potent antimicrobial properties, lack of bacterial resistance, and small molecule penetration capabilities could provide a promising alternative, non-antibiotic approach to treating infections in people living with this disease.

“The clearances by Health Canada will enable us to expand our work with this novel therapy to a wider range of people with an exceptional need for more effective antimicrobials and represents another important opportunity for Novoteris,” stated Alex Stenzler, President of Novoteris.

Non-Tuberculous Mycobacteria (NTM) lung infections are caused by inhalation of these insidious opportunistic organisms in the air. In susceptible people, particularly those with Cystic Fibrosis, bronchiectasis or other chronic lung diseases, it can become a slow and progressively destructive lung disease. In many people, the prolonged use of antibiotics for more than a year may result in multi-drug resistant strains of NTM and with few antimicrobial options, can be lethal. NTM is a significant emerging threat affecting morbidity and mortality in CF patients with an estimated post millennium prevalence median of 13%.

Nitric oxide is a molecule naturally produced by the body and plays an important role in every organ system, including the innate defense system against microorganisms. Externally delivered nitric oxide has been demonstrated to be an effective antimicrobial agent against a broad spectrum of microbes, including drug-resistant strains. A lower concentration of nitric oxide is already an approved drug on the market from other manufacturers for the treatment of pulmonary hypertension in newborns.

“We anticipate that this study of nitric oxide will provide an opportunity to test this novel therapy in this patient population who have been waiting for an effective treatment,” added Dr. Miller, Chief Technology Advisor.

Novoteris, LLC is a privately held limited liability company managed by a group of international industry veterans and clinicians involved in developing and producing innovative, cutting-edge medical products. The company was formed in 2013 to consolidate the nitric oxide assets and other resources from 12th Man Technologies, Inc. (Garden Grove, CA) and Nitric Solutions, Inc. (Vancouver, Canada) for the completion of inhaled nitric oxide trials for the treatment of patients with cystic fibrosis. The company received Orphan Drug designations for the treatment of cystic fibrosis from both the FDA and EMA in 2013. Novoteris is headquartered in Garden Grove, CA, with an EU entity in Belgium (Novoteris GVC). For more information, visit www.novoteris.com.