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SoftOx Solutions AS Regulatory Filings 2021

Apr 9, 2021

3747_rns_2021-04-09_7dd9b338-1ed2-406c-a057-614d145d7189.html

Regulatory Filings

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SOFTOX SOLUTIONS AS: NATIONAL COMMITTEE ON HEALTH RESEARCH ETHICS APPROVES FIRST-IN-HUMAN CLINICAL STUDY FOR SOFTOX WOUND TREATMENT AGENT FOR CHRONIC WOUNDS, BIOFILM ERADICATOR (SBE)

SOFTOX SOLUTIONS AS: NATIONAL COMMITTEE ON HEALTH RESEARCH ETHICS APPROVES FIRST-IN-HUMAN CLINICAL STUDY FOR SOFTOX WOUND TREATMENT AGENT FOR CHRONIC WOUNDS, BIOFILM ERADICATOR (SBE)

The National Committee of Health Research Ethics (NVK) in Denmark has approved the “SBE-01 study”, a first-in-human, phase I clinical trial in patients with chronic wounds. The study has now received full regulatory clearance to make the final preparations for initiation. Reference is made to the previous stock announcement of 15th March 2021 regarding authorisation from the Danish Medicines Agency.

"This rapid approval by the relevant regulatory bodies in Denmark will enable us to start the study during Q2-2021" says Glenn Gundersen, Medical Director in SoftOx Solutions.

SBE-01: EudraCT no. 2021-000314-42.

For further information, please contact:

Geir Almås, CEO of SoftOx Solutions AS, or

Glenn Gundersen, Medical Director of SoftOx Solutions AS

Mail: [email protected]

Phone: Front Desk: (+47) 948-59-599

About SoftOx Solutions AS

SoftOx Solutions AS is a Norwegian BioTech company listed on Euronext Growth

Oslo. Our Vison is “Helping the world fighting infections - developing new ways

of eradicating infections and fighting antimicrobial resistance”. We are working

to combat major threats to human health, namely the emergence of antimicrobial

resistance (AMR), biofilm infections in chronic wounds and the spread of

viruses. For more information on SoftOx, visit www.soft-ox.com