The instructions for use and videos on how to take the trial medicine are now available online. Trial participants and care givers can access this information on this website in the “Clinical” trials section on the Resources Page
The OligoGpivotalCF trial is about to start recruiting. On 6th May 2020 the first site was initiated in Wels, Austria and more site initiation visits are planned for the coming months. Pending the normalization of the Covid-19 pandemic, the trial will open for patients at several sites in Europe soon.
If you want to know more, visit www.OligoGpivotalCF.eu
We have now received regulatory approvals from Austria, UK, Germany and Ireland, and ethics approvals from Austria and UK. Ethics approvals from Germany and Ireland are expected to follow soon in order for us to proceed with the OligoGpivotalCF clinical study.
However, due to the current situation with COVID-19, we have decided to postpone site initiation visits until after April 12 (Easter break) to minimize the risk for the CF community.
The Cystic Fibrosis Foundation (CFF) has recently issued guidance, based on recommendations from the US CDC and local health authorities, which we believe is also prudent to adopt here.
An EU Horizon 2020 proposal (OligoGpivotalCF) submitted by a consortium assembled by AlgiPharma with the University Hospital in Cologne, Imperial College London in the UK, the European Cystic Fibrosis Society (ECFS) in Denmark and ECFS’s Clinical Trial Network in Belgium, the Cystic Fibrosis Europe patient organization in Bonn, and the CRO Smerud Medical Research in Oslo, has been successful in winning a grant of EUR 6 million to support AlgiPharma’s cystic fibrosis (CF) drug candidate OligoG through a pivotal clinical trial program. This project has received funding from the European Union’s Horizon 2020 research and innovation programme “Health, demographic change and well-being” (call H2020-SC1-2016-2017) under grant agreement No 755234.
About the project
OligoG-pivotal-CF is a multinational clinical project to test the orphan drug OligoG CF-5/20 (OligoG) in a pivotal phase 2b clinical trial for the treatment of cystic fibrosis (CF). The project is funded by the H2020-SC1-2017-Two-Stage-RTD, topic SC1-PM-08-2017, and represents a new therapy for the rare disease cystic fibrosis (CF). The study drug OligoG CF-5/20 (OligoG) has received an EU Orphan Drug Medicinal Product Designation in 2007 and an FDA Orphan Drug Designation February 2016, both for the treatment of cystic fibrosis.
This project has received funding from the European Union’s Horizon 2020 research and innovation programme part “Health, demographic change and well-being” (call H2020-SC1-2016-2017) under grant agreement No 755234.