DEEP Project Newsletter n.4

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: an update of the clinical centres involved

Another step forward has been made toward the enrollment of new patients in the DEEP-2 study, a phase III multicentre, randomised, open label, non-inferiority active-controlled trial aiming at comparing for the first time the efficacy and safety of deferiprone (DFP) vs deferasirox (DFX) in paediatric patients affected by hereditary haemoglobinopaties requiring chronic transfusions and chelation.
The DEEP-2 study actually involves a total of 227 patients included in 32 recruiting centres: Italy (51), Egypt (123), Greece (9), Albania (25) Tunisia (7) and UK (10). The first nine patients have been enrolled in UK and 10 in Tunisia this week. The enrollment will terminate when 344 patients will have been randomized.

DEEP-3: an update on the observational study

DEEP-3 is a long-term observational safety study which evaluates the nature and incidence of adverse effects of deferiprone (DFP) in children and adolescents with beta-thalassaemia major and currently involves 18 recruiting centres from 7 different countries: Albania, Cyprus, Greece, Egypt, Italia, Morocco and Tunisia.
On October 2015, 283 patients (86% of 328 subjects of the study population) were enrolled, 36 of which are currently in the prospective phase of the study. The observation, which aims to investigate serious and non-serious adverse reactions, as well as risk factors for ADRs related to deferiprone treatment, has ended for 166 patients. The mean observation time per patient was currently 2.1 years, with 595 person-years (84% of 711 person-years).

Follow DEEP on Social Networks!

DEEP has created its own official Google+ and Facebook page!

By exploiting these very useful two-way communication forms of media, all project activities and results can be shared more quickly with a wide public audience while anyone interested in the project has the opportunity to contact the DEEP partners directly.

DEEP has also created a dedicated Youtube channel where all interviews with key DEEP staff and opinion leaders are available.

Stay connected with our Social Networks to find out what DEEP is working on day by day and share if you like!

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NEWS

Next DEEP General Assembly will have the Tunisian colour

The 7th General Assembly (GA) will take place in Tunis (Tunisia) on 12th-14th December 2015 with the participation of the whole DEEP Consortium as well as of external experts. The meeting will mainly focus on a general update of the projects activities, achievements and planning of future steps. 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.

The Story of the project as described in the Scientific report to the EC

The most important achievements and activities carried out by the project have been collected and included in the DEEP Scientific Report related to the period from 01/01/2014 to 30/06/2015 which has been submitted to the European Commission on September 2015.
The report provided a comprehensive overview of the activities performed with particular reference to the implementation of the DEEP studies in compliance with the Paediatric Investigation Plan (EMEA-001126-PIP01-10), as approved and further amended by the Paediatric Committee (PDCO).

QuBo, the multicenter observational transversal study for patients involved in the DEEP-2 trial

The Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) has recently launched the multicenter observational transversal study “Quality evaluation of the informative booklets for patients involved in the DEEP-2 trial” (QuBo). The overall aim of this study is to investigate the quality of the informative material addressed to paediatric patients involved in DEEP-2, in order to evaluate the level of comprehension and the likeability of the informative documents proposed in the clinical trial to paediatric patients.

EVENTS

DEEP at the VIII edition of the Foresight Training Course

On September 22nd-23rd, 2015, the DEEP project as a best practice for the trial management in EU/non-EU paediatric trials was presented at the VIII edition of the Foresight Training Course (FTC), hosted by the Children’s Memorial Health Institute in Warsaw (Poland) and promoted by the Gianni Benzi Pharmacological Research Foundation (FGB, Italy) in collaboration with the EU-funded project GRiP (Global Research in Paediatrics).

“New Challenges in the Management Of Iron Overload”
DEEP at Rhodes (Greece)

On May 21st-22nd 2015, the city of Rhodes (Greece) hosted the meeting “New Challenges in the Management Of Iron Overload”, with the participation of international prominent personalities in the field of Thalassaemia and Haemoglobinopathies.
The workshop, organised with the support of ApoPharma Inc., was mainly focused on the Iron chelation therapy and has foreseen two different physician breakouts, interactive sessions where participants were divided into two groups and rotated for a 45 minute case forum, with participants encouraged to bring their “own clinical cases” to discuss and share with the experts.

DEEP on the National Albanian Television

In the context of 3rd edition of the DEEP Open Meeting “Networking and Innovation for local development” organised in Tirana (May 18th, 2015) in collaboration with the University Hospital Center “Mother Teresa” (UHCT), Donato Bonifazi, DEEP Project Manager and Dr. Manika Kreka, DEEP-2 Principal Investigator have been interviewed by the National Albanian Television.
They have highlighted the progresses achieved by the clinical research in Albania so far and the importance of a more tight international collaboration within the European Networks to create synergies to spread excellence and attract European funding.