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Aussie firm initiates bronchitis drug trial for smokers

23 July 2013 | News | By BioSpectrum Bureau

Invion commenced patient enrolment in its phase II clinical trial of INV102 (nadolol) in patients with chronic bronchitis

Invion commenced patient enrolment in its phase II clinical trial of INV102 (nadolol) in patients with chronic bronchitis

Singapore: Australia-based clinical-stage drug development company, Invion, initiated and commenced patient enrolment in its phase II clinical trial of INV102 (nadolol) in patients with chronic bronchitis, who are enrolled in a validated smoking cessation program.

INV102 (nadolol) has been used in more than eight million people for the treatment of high blood pressure, migraine and chest pain. Invion is repurposing this drug and targeting it to the treatment of chronic inflammatory lung conditions, including asthma and chronic obstructive pulmonary disease (COPD).

The randomized trial is being conducted at two centres in the US, in which up to 136 patients will be enrolled. The primary objective is to evaluate the efficacy of INV102 in subjects with chronic bronchitis in improving rates of smoking cessation over a 10-to-12 week treatment period. The primary outcome measure is the change from baseline in the average number of cigarettes smoked per day.

The principal investigator is Dr Albert A Rizzo, who is a renowned pulmonary specialist, chief of Christiana Care's Pulmonary and Critical Care Medicine Section, and former chair of the American Lung Association. Dr Rizzo is board-certified in internal medicine, pulmonary disease, critical-care medicine and sleep-medicine disorders.

Dr Greg Collier, MD and CEO, said that, "The data generated from this trial will not only potentially advance a novel therapy for smoking cessation, but it will also add to the already strong data package in our wider asthma and COPD program. This is a very exciting time for this company."

Dr Mitchell Glass, executive VP, R&D, and chief medical officer, said that, "Tobacco is a known or probable cause of at least 25 diseases, including cancers, heart disease, stroke, emphysema and other chronic lung diseases. This is a significant global health problem and represents an enormous commercial opportunity. A therapy which can reduce or eliminate smoker's cough, a common barrier to quitting smoking, could be life changing for patients."

In 2011 the global market for asthma and COPD prescription drugs was valued at $34 billion, with a five year compound annual growth rate (CAGR) of 4.4 percent.

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