March 25th, 2016

DEEP Project Newsletter n.5

The DEEP Project has already brought forth its first results and is continuing along the challenging path of a large, multinational clinical trial, which led in the first phase of the project to a new formulation of deferiprone with a better taste suitable for children, as well as valuable data on the safety of deferiprone and on the correct dosage to be administered.
 DEEP-2: almost at the final rush

Another step forward has been made toward the enrollment of new patients in the DEEP-2 study, the phase III multicentre, randomised, open label, non-inferiority active-controlled trial aiming at comparing for the first time the efficacy of deferiprone (DFP) vs deferasirox (DFX) in paediatric patients affected by hereditary haemoglobinopaties requiring chronic transfusions and chelation.
 7th DEEP General Assembly meeting in Padua

After the sad decision to cancel the General Assembly Meeting in Tunis, due to the disorders which have occurred across the country, the 7th DEEP General Assembly (GA) will take place in Padua (Italy) on April 13th -15th, 2016 with the participation of the whole DEEP Consortium as well as of external experts.
The meeting will be focused on a general update of the project's activities, the progresses and achievements of the DEEP project as well as the finalization of the DEEP-2 and DEEP-3 studies, that are of utmost priority. Among others, the possible amendment to the Protocol as well as the financial resources reallocation according to the recruitment performance at any involved centre will be discussed during the meeting.
In the same context of the GA meeting, the DEEP-2 Investigator Meeting and the 4th Open Meeting will take place.
 DEEP-3 at a glance:
interview to Prof. Antje Neubert 

What is the progress of the study that is to date in the last collection rush for most of the centres involved and which are its main progresses and achievements?


 Performing a paediatric clinical study in Tunisia:
interview to Prof. Mohamed Bejaoui 

We have discussed the Tunisian situation in performing a paediatric clinical study with Prof. Mohamed Bejaoui, the Principal Investigator at the Centre National de Greffe de Moelle Osseuse in Tunis.


 The ApoPharma point of view:
interview to Dr. Michael Spino

We asked Dr. Michale Spino, President of ApoPharma Inc. to describe the major contribution provided by ApoPharma, one of the project beneficiary, in the fulfillment of the project and what contribution could still be provided.



Medical care and transition phase of thalassemia in different countries: the ICET-A experience

During the last Enpr-EMA (European Network of Paediatric Research at the European Medicines Agency) workshop, held in May 2015, adhering networks have been invited to provide a feedback on published guidance documents on the topic of transition from paediatrics to adults clinical care settings within the long-term clinical studies and follow up for chronic diseases.

The Italian Multiregional Thalassemia Registry: centers characteristics, services and patients’ population

Consorzio per Valutazioni Biologiche e Farmacologiche’s research activity in the pharmacological field is much diversified and it is mainly conducted in the context of national and EU level. It is focused on the development and application of innovative methodologies in clinical trials on small populations, the management of interventional, non-interventional, health technology assessment and pharmacoeconomics studies, and disease registries.

DEEP joins Rare Disease Day in making the voice of rare diseases heard!

The 29th February, 2016 marked the ninth international Rare Disease Day coordinated by EURORDIS. The main objective of Rare Disease Day was to raise awareness amongst the general public and decision-makers about rare diseases and their impact on patients’ lives. The campaign targeted primarily the general public and also sought to raise awareness amongst policy makers, public authorities, industry representatives, researchers, health professionals and anyone who has a genuine interest in rare diseases.

Prof. Amal El-Beshlawy: Winner of Sultan bin Khalifa 2015 International Thalassemia Award (Abu Dhabi, October 21st, 2015)


DEEP at the Congress of the Italian Society of Pharmacology
(Naples, October 30th, 2015)

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DEEP - DEferiprone Evaluation in Paediatrics
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