In last trading session, the stock price of Arch Therapeutics Inc (OTCMKTS:ARTH) declined more than 2% to close the trading session at $0.830. The decline came at a share volume of 1.04 million compared to average share volume of 1.16 million.
Arch Therapeutics, developer of the AC5™ device for use in controlling fluid loss and bleeding to offer safe and faster interventional and surgical care, reported that it had completed enrollment process in its first clinical trial to evaluate the performance and safety of AC5 in humans. The trial is being done in collaboration with CÚRAM, and the Clinical Research Facility of National University of Ireland Galway.
For the AC5 clinical trial, which is planned in Ireland, 46 subjects have been enrolled. Arch Therapeutics expects reporting the trial results during summer 2016 after it concludes the subject follow-up assessments of 30-dayfollowed by statistical analysis. The objectives include product-linked adverse events and hemostasis duration. So far, there are no severe adverse events reported from this clinical study.
The expert view
Terrence W. Norchi, the CEO and President of Arch Therapeutics, reported that this is yet another achievement for company on its way towards regulatory nod of AC5. As the planned enrollment has been done, they are awaiting completion of the one-month follow-up assessments. The CEO added that they are eager to receive the data from the statistical analysis, and they look forward to releasing the trial results this summer.
Arch Therapeutics expects submitting a CE mark application for its key candidate ‘AC5’this summer and is in the process of planning its next regulatory measures for both the United States and the EU. Professor AbhayPandit, who is the Director of CÚRAM, stated that CÚRAM are excited to support Arch Therapeutics through this study and in their mission to commercialize AC5.