Press release from Companies
Publicerat: 2022-01-11 08:30:00
Respiratorius announces that the PK study is now approved by the Health Authorities (HA) in the country for the PK study conduct. The study has previously been approved by the Ethics Committee (EC) but the recent minor changes requested by the HA need to be reviewed and re-approved by the EC before the study can be initiated. Thereafter the study can be initiated, and study subjects can be recruited as soon as possible.
The patent pending novel formulation, VAL001, combines immediate release and extended-release characteristics of sodium valproate contained in a capsule formulation. This tailored release profile will be evaluated in a pharmacokinetic (PK) phase I study in healthy subjects. "Intitiating the PK study of the VAL001 drug product is yet another significant milestone enabling a novel product for treatment of DLBCL patients before initiating standard R-CHOP immunochemotherapy, says CEO Johan Drott in a comment. This disclosure contains information that Respiratorius is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 11-01-2022 08:30 CET. Johan Drott President Respiratorius AB +46 709-22 41 40 johan.drott@respiratorius.com Respiratorius AB (publ) is developing drug candidates with the goal to launch drugs for common diseases cancer, chronic obstructive pulmonary disease (COPD) and severe asthma. In addition, the project portfolio is a project for improved diagnosis of certain cardiovascular diseases.
