Oct 15, 2013
LTX-315 is approved for a new exploratory phase I study in Europe

The Cancer Immunotherapy Drug Candidate LTX-315 is ready for the next clinical trial

Lytix Biopharma has received approvals from the Norwegian Medicines Agency (NOMA), the Medicines and Healthcare Products Regulatory Agency (MHRA) in UK and the Federal Agency for Medicines and Health Products (FAMHP) in Belgium as well as all ethical committees in the corresponding countries to start the next exploratory Phase I study. The clinical trial applications were submitted to the health authorities in July. The collaborating partners for the clinical trial will be Oslo University Hospital - Radiumhospitalet, Guy’s and St. Thomas Hospital, London, Institut Jules Bordet, Brussel  and Universitaires St-Luc, Brussel. Recruitment of cancer patients will start soon at the four clinical sites.

 

På norsk:

Lytix Biopharmas legemiddelkandidat mot kreft, LTX-315, er klar for neste kliniske studie

Lytix Biopharma har mottatt godkjennelser fra Statens legemiddelverk (NOMA), ‘the Medicines and Healthcare Products Regulatory Agency’ (MHRA) i Storbritannia og ‘Federal Agency for Medicines and Health Products (FAMHP) i Belgia samt alle etiske komiteer i de nevnte land for å starte neste utforskende Fase 1-studie. Søknaden om den kliniske studien ble sendt til helsemyndighetene i juli. De samarbeidende partnere for den kliniske studien vil være Oslo universitetssykehus - Radiumhospitalet, Guy and St. Thomas Hospital, London, Institut Jules Bordet, Brussel, og Universitaires St-Luc, Brussel. Rekruttering av kreftpasienter vil starte snart på de fire kliniske sentrene.