Ethypharm’s 5-FU loaded microspheres "positively better in first line glioblastoma cancer therapy." Partnering opportunities for commercialisation
Ethypharm, based in Paris, France, a leading player in drug delivery systems (DDS) has reported positive Phase II clinical trial results for its novel 5-fluorouracil (5-FU) microspheres for local treatment of patients with glioblastoma, one of the most aggressive forms of brain cancer.
Ethypharm’s product is an elegant new method of delivering localised and sustained 5-FU to the brain. Implanting biodegradable microspheres containing 5-FU locally, completely surrounding the surgical resection cavity, allows a controlled-release of the 5-FU directly into the brain tissue. The 5-FU acts as a local radiosensitiser, greatly enhancing the efficacy of radiation therapy, which is normally used to treat this aggressive form of brain cancer.
Patients in a group that had undergone complete resection of the tumour were then treated with the 5-FU microspheres in conjunction with radiotherapy. They fared better than the control group of patients in terms of survival. Also, local relapses and tumour recurrence was 20% less frequent than patients given standard treatment without the 5-FU microspheres.
This use of 5-FU has been made possible because of Ethypharm’s unique microsphere technology. It represents a significant advance in the local control of residual cancer cells, which might otherwise remain once the tumour has been removed surgically.
Ethypharm plans further development of its 5-FU microspheres and is looking for a partner to assist it with the product’s clinical programme and commercialisation.
The company received "orphan drug status" for this product in the US (1999) and in Europe (2000), providing seven and ten years exclusivity, respectively, in these key markets.
Keywords : Ethypharm France Drug delivery systems (DDS) 5-FU microspheres Brain cancer Glioblastoma Surgery Radiotherapy Local treatment Sustained release Phase II clinical trial Partnering Commercialisation
