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DEEP Project Newsletter

5th DEEP General Assembly
Special Focus
The DEEP Project, currently in its fourth year of life, has already brought forth its first results and is continuing along the challenging path of a large, multinational clinical trial. Its achievements so far have led to a new formulation of deferiprone for the treatment of iron overload in paediatric patients affected by congenital, transfusion-dependent anaemias. The DEEP Project success is essentially based on the fulfilment of three studies:
DEEP-1 PK Study

The DEEP-1 trial is successfully completed with the inclusion of 18 young patients. For the first time, there is scientific evidence that the dosage of deferiprone used in adults can provide sufficient exposure to ensure efficacy also in small children aged from 1 month to < 6 years.  

Despite the difficulty in running pharmacokinetic studies across different centres, the team congratulates the investigators and their staff for the rigour held during the sampling process which has led to very good quality of the generated data. The final clinical study report, with details of the study population and data analysis, will soon be available.

A ‘Diploma’ has been distributed to the young participants to thank them and acknowledge the importance of their collaboration. Thanks to their participation we know the appropriate dosage of deferiprone to be used in very young patients.
DEEP-2 Safety/Efficacy Study

The DEEP-2 trial involves clinical sites from the Mediterranean area where β -thalassemia major is more widespread: Albania, Cyprus, Egypt, Greece, Italy and Tunisia. Together they are expected to enrol 344 patients. The approval of the study has been already granted in 13 centres, among which 5 Italian centres are already recruiting while Albania and Egypt are about to start.
 
What is remarkable about this is that, despite the fact that in some of the countries - such as Albania - there is no legislation nor dedicated organisation for interventional trials, DEEP-2 is ready to start. In Albania DEEP-2 represents the third clinical trial ever performed. Moreover, in order to increase enrolment capacity, the possibility to include additional centres in North Africa, such as Morocco, Jordan and supplementary Egyptian sites, is under evaluation.
 
An important aspect of the DEEP-2 Study is the evaluation of deferiprone efficacy not only in patients affected by β-thalassaemia major but also in other hereditary haemoglobinopathies, including Sickle Cell Disease, especially thanks to the inclusion of clinical sites in the UK.
DEEP-3 Long term Safety Study

DEEP-3 is an observational study evaluating the long term safety of deferiprone in children with β-thalassaemia major. The collected information refers to deferiprone use in paediatric patients (less than 18 years of age) both retrospectively and prospectively. Most importantly, as this is a safety study, data collection is focused on adverse events reported during deferiprone use both as monotherapy and in combination with deferoxamine.

At the moment there are 16 actively recruiting study centres located in Albania, Cyprus, Egypt, Greece and Italy. Altogether 126 patients have been enrolled in the study. The observation has been already completed for 51 patients and will continue until the planned observational period of 400 patients will be completed.

5th DEEP General Assembly


The 5th DEEP General Assembly took place from the 3rd to the 5th of July 2014 in the legendary city of Athens, Greece, with the participation of the whole DEEP Consortium as well as of external experts. The main contents presented and discussed were:
  • DEEP-1 Results
  • Organization of the DEEP-2 Trial
  • DEEP-2 Recruiting Centres
  • DEEP-3 Long Term Safety Study
The GA presented the opportunity to hold an open Scientific Meeting on July 5th, which focussed on specific topics of interest in the field of iron chelators and iron overload.

Given the general interest of the topics discussed during the event, Professor Aurelio Maggio suggested the opportunity to publish the proceedings of this session in the journal Thalassaemia Report.

Participants interested in drafting one or more papers/reports on these topics may contact the DEEP team coordinating the publications: deep@cvbf.net.
Read more about the General Assembly

Publications and Dissemination activities
Press
So far several articles on the Project have been published in magazines, including:

- research*eu results

- EU Commission CORDIS website

- HorizonHealth.eu

- Ricerca&Medicina
 
Official Project Website
Renewed with a section dedicated to families and children and available in the six Project languages, the website is being is constantly updated with news on the ongoing activities.
 
Conferences
The Project development and implementation has been presented in the framework of different external meetings and conferences focused on paediatric research on thalassemia, such as the TIF World Congress and the EuroMed Common Challenges Meeting.
 
Information Booklets and Assent Forms
The DEEP Project has developed age-tailored information booklets and assent forms in the six Project languages to explain the clinical trial procedures to the children involved in DEEP-2.
 
 
Newsletters
Updates on the three clinical studies are provided regularly through Study Newsletters available on the Project website. These include project related scientific aspects and are published every two months.
Project Newsletters, on the other hand, aim to spread project news to a wider audience.
“Living Well with Thalassemia”
This booklet is currently available in Albanian, English, French, Greek, Italian as an informative tool created mainly for patients and parents to provide them with insights on the disease and its treatment.
 
The project activities are progressing and generating results. In the next few months important advancements will be made in DEEP-2 and DEEP-3 in terms of patient enrolment and data collection. The PDCO approval of the overall clinical development and the clinical results, supported by a market and budget impact analysis of the new formulation, will provide iron overloaded children with an alternative chelator specifically formulated for them.
Our mailing address is:
deep@cvbf.net

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This project has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement n.261483.