Innovative Therapies for Children with Cancer in Europe

ITCC clinical trials

How ITCC was born?

Over the past 10 years, initiatives have been undertaken by paediatric oncologists in Europe to promote the clinical evaluation of new anti cancer compounds in children within national academic paediatric groups.

 

In 1995, a collaboration was established between the Pharmacology group of the French Society of Paediatric Oncology (SFOP) and the New Agents Group of the United Kingdom Children’s Cancer Study Group (UKCCSG), which represents 20 clinical paediatric oncology centres.

 

Between 1995 to 2003, 17 phase I and II trials evaluated 10 different anti-cancer drugs and recruited 559 children and adolescents with malignancy (Sue Ablett and al, Eur. J. of Cancer 40 (2004) 1886-1892).

 

In 2001, other European cooperative groups, in the Netherlands, Italy and Germany, expressed their interest in participating in early clinical drug trials.

 

At that time,major changes were made in the regulatory environment in Europe and the US to encourage or incite pharmaceutical companies to study their compound in children. In Europe, The Orphan Drug Act was launched in 2000 and offered advantages for the development of new drugs in rare diseases, such as paediatric malignancies.

 

In 1997, in the US, the “Best Pharmaceuticals for Children Act” recognized the importance of properly evaluated drugs for children and promoted paediatric studies throughout new product development programs. Through the Paediatric Rule and the Paediatric Exclusivity provision, this law has been successful in the US (Jennifer S.Li and al, JAMA, February 7, 2007-Vol 297, n°5).

 

In 2000, the EU parliament adopted a resolution for better medicines for children in Europe and DG enterprise embarked on the development of this regulation, which was finally adopted in second reading by the EU parliament in December 2006.

 

In early 2002, we anticipated that this Regulation would profoundly change the European landscape of drug development for children with cancer through incentives for pharmaceutical companies. We decided to structure and develop a European academic Network to properly address paediatric drug development when the Regulation came into force. The concept of ITCC was born.

 

ITCC was formally created on March 25th, 2003, the day we submitted the project in reply to the first Cancer Call of the 6th Framework program. Unfortunately, our project, which was one of the very few projects addressing pediatric malignancies, was not selected.

In spite of the lack of formal funding, the ITCC consortium came into being through institutional resources, developing partnerships, collaboration, clinical and biology projects. This shows the clear commitment of all partners to work together, to combine our expertise and strength, and to create a critical mass that is well integrated in the European pediatric oncology research area.

 

In November 2006, the EU issued a call for research project in the field of innovative diagnostics and treatments for cancer in children. ITCC submitted the KidsCancerKinome project, which focuses on basic science to identify new targets, part of the global ITCC project. KidsCancerKinome was selected, funded and launched on November the 1st, 2006

 

The European Regulation is in force in Europe since January 27th, 2007. ITCC is ready to actively participate in the development of innovative therapies that will improve the cure rate and quality of life of children with cancer.