Updates

April 16th, 2020 – The “Protocol for Application, Standardization and Validation of the Forskolin-Induced Swelling Assay in Cystic Fibrosis Human Colon Organoids” has been published in STAR Protocols, a Cell press journal. Check out more details in Scientific Publications.

 

April 7th, 2020 – The Coronavirus crisis is not stopping the HIT-CF coordinating team! Regular online meetings are held to prepare for the next step in the project: the clinical study testing Proteostasis compounds in patients with high organoid responses. About one third of all patients are currently screened.

 

April 6th, 2020 – Due to the Covid-19 world crisis, lab activities throughout Europe has been put on hold.

Iris Silva is the responsible for the organoids screening at Lisbon University. Part of the organoids, which were grown from rectal biopsies collected from CF donors, are to be tested there at Lisbon University in order to evaluate how the organoids respond to the drug candidates. These tests will determine who can participate to the clinical trials planned to start end of 2020. Screening is on stand by now, but Lisbon lab will do its best to keep up with the timeline! – Iris Silva says:

 

March 30th, 2020 – The Covid-19 epidemic continues impacting every aspects of the HIT-CF project. KU Leuven and Eloxx Pharmaceuticals tell us what this crisis has changed for them and what it means for the project.

The CF research lab at the Catholic University of Leuven (KU Leuven) in Belgium is one of the academic sites participating in the screening of the organoids, with the objective to identify new compounds to treat CF in patients with rare mutations.

“At the moment, due to the Covid-19 crisis and according to the national guidelines implemented at the University to limit the spreading of the virus, we had to postpone all the work in the lab, including the screening of the drug candidates in the CF organoids” says Anabela S. Ramalho, post-doctoral researcher responsible for the CF research lab at KU Leuven.

“All the samples that have not been yet tested are safely stored (frozen) and will be analysed when the new guidelines allow to return to work in the lab, hopefully as soon as possible. In the meantime, we will work further on the analysis of the data that was already collected.​”

Below, Anabela S. Ramalho gives us a tour of the unusually quiet and deserted lab at KU Leuven:

 

Eloxx Pharmaceuticals (Waltham, MA, USA), industrial partner providing drug candidates, is also implementing safety measures:

“In response to the Covid-19 pandemic, Eloxx has temporarily paused enrollment across our Cystic Fibrosis clinical trials in an effort to avoid unnecessary exposure in at-risk populations, to main tain the integrity of our study data and to support global healthcare providers in their commitment to ensure patient safety. Despite this pause, Eloxx Pharmaceuticals remains committed to the HIT-CF consortium and the broader cystic fibrosis community and will continue our efforts to advance novel therapeutics for patients with unmet medical needs.”

March 26th, 2020 – Proteostasis Therapeutics Inc. (Boston, MA, USA) is one of our industrial partners in this outstanding adventure. They also have taken measures to contribute to the hindering of the epidemic spreading throughout the globe, president and CEO explains:

March 23rd, 2020 – Covid-19 epidemic is impacting research and the HIT-CF project

The ECFS-CTN coordinating centre in Leuven, Belgium, is fully operational at the moment, with everybody working from home. The clinical trial sites part of the network are implementing contingency plans for ongoing trials in cooperation with study sponsors and based on the local situation and guidelines, to maximise patient safety.

Below, Kors van der Ent, coordinator of the HIT-CF project at UMC Utrecht, gives an update of the current status of the project and of what awaits us in the months to come. “Stay strong, and stay safe, we will overcome the crisis, and we will win the battle against CF!”

 

February 24th, 2020 – Today the HIT-CF consortium announces the successful completion of the first phase of the project with the collection of biopsies from 502 people with ultra-rare forms of cystic fibrosis (CF). You can find the press release here

September 19th, 2019 – We are hitting CF where it hurts! An interesting storytelling article on HIT-CF was published in the year report of the ECFS Clinical Trials Network, including more background information on the project, and interviews with a scientist and doctor working on the project. Download it here!

April 25-26, 2019 – Kors van der Ent and Peter van Mourik of the HIT-CF coordination team visited the pharmaceutical companies Eloxx, Proteostasis and Flatley Discovery Labs in Boston who are partners in the project. They discussed the first results of the HIT-CF project and were thrilled to see that these companies are developing additional new drugs which will have a high impact on the lives of CF-patients in the future. The HIT-CF program is now open for patients with ultra-rare mutations in many countries. Find out more about the possibilities in your country here or use the contact form.

 

March 15, 2019 – Busy times ahead for HIT-CF organoid screening teams: on March 14 and 15 the HIT-CF lab-teams of Lisbon, Leuven and Utrecht met in Lisbon. The teams were welcomed by Prof Margarida Amaral at the University Faculty of Science. The teams took decisions on several Standard Operating Procedures on the organoid testing and prepared a meeting with the European Medical Agency. They also formally started the Screening Phase of the organoids of the first patients. The teams are facing a very busy period, because all patients in HIT-CF should be included in the next coming months!

 

March 11, 2019 – Another productive week for the HIT-CF consortium: the first Belgian patient has been included, and the paperwork for ethical approval in the UK has been submitted!

February 27, 2019 – HIT-CF welcomes Proteostastis Therapeutics and Eloxx Pharmaceuticals to the consortium! We will test Proteostasis’ lead corrector (PTI-801), potentiator (PTI-808) and amplifier (PTI-428) on the organoids of CF patients having extremely rare genetic mutations. To learn more about Proteostasis, read their press release here. Eloxx will bring its investigational compound ELX-02 to the consortium. We will test this drug candidate on the organoids of people with CF having a nonsense mutation. To learn more about ELX-02, read the press release here. Because these drug candidates aim to improve CFTR function in new ways, people with specific CFTR mutations that previously could not participate in the study, are now able to join! Please check the updated criteria here.

January 16, 2019 – The first rectal tissue samples have been grown into organoids. Our teams in Lisbon (Portugal), Leuven (Belgium) and Utrecht (The Netherlands) are ready to start testing the drug candidates!

Iris Silva, University of Lisbon

 

Anabela Ramalho & Eva Furstova, KU Leuven

 

Annelotte Vonk, UMC Utrecht

 

December 12, 2018 – With the first Israeli patients being included, HIT-CF is now really coming up to speed!

November 27, 2018 – First Czech patients included. Already 13 Dutch participants and 1 patient from Sweden! Inclusions in Belgium and Israel expected to start before the end of this year. More countries to follow!

 


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Contact information

HIT-CF Europe
Joseph Borlélaan 12
1160  Brussels
Belgium