Cancer Research Technology Secure Orphan Drug Designation for Fenretinide on Behalf of Cancer Research UK
London, UK 27 February 2007 – Cancer Research Technology Limited (CRT), the oncology-focused development and commercialisation company, today announce that Cancer Research UK has received orphan drug designation for use of fenretinide in the treatment of Ewing’s Sarcoma Family of Tumours from the Food and Drug Administration (FDA) and for the treatment of soft tissue sarcomas and malignant bone tumours from the European Commission.
The orphan drug application was based on studies, led by Dr Sue Burchill at Cancer Research UK’s Clinical Centre in Leeds, that have shown promising results following application of fenretinide in experimental models of the Ewing’s Sarcoma Family of Tumours (ESFT). Proof of concept studies have demonstrated that fenretinide significantly delays tumour growth in models of bony Ewing’s sarcoma and soft tissue peripheral primitive neuroectodermal tumour (pPNET). In addition, in vitro investigations have shown that ESFT are particularly sensitive to the death inducing activity of fenretinide.
Fenretinide is a vitamin A analogue and has been tested in phase I trials in children and adults. The drug was originally developed for the treatment of breast cancer, but did not receive marketing authorisation in this indication and is now off-patent. Orphan drug designation will support the clinical development of fenretinide in soft tissue sarcomas and malignant bone tumours by providing CRT and any future development partners with guidance from the FDA and the EMEA, together with fee reductions, accelerated approval and 7 and 10 years of market exclusivity in the US and the EU respectively. CRT will be seeking a licensing and codevelopment partner for use of fenretinide for the treatment of ESFT.
ESFT are most frequently diagnosed in children and young adults between the ages of 10 and 25 years and include Ewing’s sarcoma and extraosseous Ewing’s sarcoma, pPNET and Askin’s tumour. The annual incidence rate of Ewing’s sarcoma for children in the US is approximately 2.9 per million and in Europe is approximately 1 per million. Current treatment approaches include surgery, radiotherapy and chemotherapy, with 5-year survival rates of approximately 60% for those diagnosed with localised disease and 20% in those with disseminated disease. In childhood indications where the market is small, designation of orphan drug status is vital in securing resources for the development of new treatments.
Following orphan drug designation, Cancer Research UK will be conducting a phase II clinical trial of fenretinide for the treatment of ESFT.
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For more information:
Cancer Research UK
Michael Regnier, Press Officer +44 20 7061 8309
michael.regnier@cancer.org.uk
Notes to Editors
About Cancer Research Technology
Cancer Research Technology Limited (CRT) is an oncology-focused development and commercialisation company that realises cancer patient benefit from publicly- funded research worldwide. CRT works closely with leading international cancer scientists, their institutes and funding bodies to protect, develop and commercialise oncology-related discoveries. CRT is wholly owned by Cancer Research UK, the largest independent funder of cancer research in the world. Further information about CRT can be found at www.CancerTechnology.com.
About Cancer Research UK
Cancer Research UK is Europe's leading cancer charity, dedicated to research into the causes, prevention and treatment of cancer. The charity supports the work of 3,000 scientists, doctors and nurses in over 80 academic centres across the UK, with an annual scientific spend of more than £257 million. Cancer Research UK is the European leader in the development of novel anti-cancer treatments; from their discovery at the laboratory bench to early clinical trials in cancer patients. Further information about Cancer Research UK can be found at www.cancerresearchuk.org.
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