S1226 Phase IIa initiated
SolAeroMed submitted a Clinical Trial Application to Health Canada regulators and on Oct 23 obtained formal regualtory approval to proceed. Work with colleagues at the Foothills Hospital under direction of Prof Richard Leigh, SolAeroMed management with support from JSS consultants, to have all required drugs and documents in place. The official start date for this Phase IIa trial was Dec 16th.
Our S1226 Phase IIa trial will be conducted over the winter months to avoid confounding pollen season allergies. The trial should be completed, analyzed, written up and reported by Q3 2015. SolAeroMed has contracted JSS Research to oversee regulatory compliance.
This trial IIa is a double blind crossover design in up to 16 asthmatic subjects treated with either placebo (saline & air) or S-1226 (perflubron & air with 8% CO2). The trial is designed to demonstrate safety and efficacy of S1226(8%) in asthmatic patients. This IIa trial will be conducted under the supervision of Prof Richard Leigh, SolAeroMed’s clinical lead & Division Chief, Respiratory Medicine & GlaxoSmithKline-CIHR Professor of Inflammaotry Lung Disease at the University of Calgary and Alberta Health Servies. JSS Research is a Contract Research Organization whose clinicians and regulatory compliance officers will ‘oversee’ all aspects of this clinical trial to ensure regulatory compliance with Good Clinical Practice.
We believe obtaining regulatory permission and advancing initiation of this trial as a major milestone in development of SolAeroMed’s S1226 asthma drug.
Formal details summarizing our trial have been uploaded at: https://clinicaltrials.gov/ct2/show/NCT02334553