News

Stay informed about the HIT-CF project! Use the buttons on the left to navigate through recent developments.

July 11th, 2022

May 19th, 2022

Today, CF Europe, the European umbrella patient organisation and HIT-CF consortium partner, participated in an expert co-creation and consultation workshop on the development of an ethics framework and a set of operational guidelines for the field of organoid research. This workshop was organized by HYBRIDA, a Horizon 2020-funded project which has as main objective to develop a comprehensive regulatory framework for organoid research and organoid-related technologies. You can find more information about HYBRIDA here.

February 28th, 2022 – Rare Disease Day is the globally-coordinated movement on rare diseases, and was set up and is coordinated by Eurordis. Rare Disease Day is observed every year on 28 February (or 29 in leap years) – the rarest day of the year.

On this occasion, the HIT-CF team worked together with Horizon, the EU Research and Innovation magazine. They have dedicated a nice article on how HIT-CF is trying to develop a path for access for people with CF with the rarest mutations. You can read the article here. Also a nice video clip was developed:

November 18th, 2021 – Last month, Mike Lensink defended his PhD at the University of Utrecht, the Netherlands. Mike obtained his doctoral degree thanks to (amongst other things) his research on the perspectives of people with CF on organoid biobanking in the framework of the HIT-CF project. As you might know, another goal of HIT-CF is to install a permanent biobank containing the organoids that were cultured for the project. To learn more about how people with CF feel about their tissue being stored and used for research and drug development by different parties, how they perceive ownership and what their wishes are concerning feedback, Mike performed 17 semi-structured interviews with people with CF. His findings will be used to inform the ethical framework and governance of the HIT-CF biobank. You can read the full article here. Congratulations Mike! We wish you all the best in you future career.

October 19th, 2021 – For the first time in about 2 years, the HIT-CF consortium met live in Brussels on 14 and 15 October. To ensure HIT-CF remains on track towards access to new treatments for people with CF caused by rare mutations, some important decisions were made. Stay tuned to hear more about it soon. 

September 2nd, 2021 – Just before summer, the HIT–CF team, in collaboration with the clinical trials
network, organised a webinar for the clinical trial sites that participated in the inclusion of participants and
where the clinical trials might also take place. See this video of Kors van der Ent giving a state of affairs during this webinar.

September 2nd, 2021 –  See this clip of HIT-CF study coordinator, Marlou Bierlaagh, explaining when screening results will be shared and why this timing is important.

September 2nd, 2021 – Watch this clip of Kors van der Ent explaining the principle of ethical biobanking.

June 2021 – Iris Silva, from the Lisbon lab, was awarded an ECFS Young Investigator Award for her abstract describing HIT-CF organoid screening results. Congratulations Iris!

October 27th, 2020 – The HIT-CF team was given the opportunity to publish an overview article on the project in the Project Repository Journal (PRj). The journal focuses on the dissemination of projects funded by the European Commission. You can read the full article here.

May 28th, 2020 – Good news for the HIT-CF project, primary screening sites at university labs of Lisboa, Leuven and Utrecht have started again the screening of the drugs on organoids!

New rules apply, such as physical distancing and masks, and only 1/3 of the staff can be at the lab at the same time, but research is back on track!

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!

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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