Pressse: 5-FU Loaded Microspheres in first line GBM therapy

SUCCESSFUL PHASE II CLINICAL TRIAL RESULTS FOR ITS 5-FU LOADED MICROSPHERES IN FIRST LINE GLIOBLASTOMA CANCER THERAPY

EP, one of the world's leading drug delivery system (DDS) companies, announced today positive Phase II trial results for its novel 5-fluorouracil (5-FU) microspheres for the local treatment, following surgical resection, of patients with glioblastoma, one of the most aggressive forms of brain cancer.

The Phase II randomised clinical trial was a comparative study which evaluated EP's 5-FU loaded microspheres and radiotherapy versus radiotherapy alone, in 77 patients following complete surgical resection of gliomas. The study showed an overall survival improvement of three months in the patient group who had undergone complete resection of the tumour and were then treated with the 5-FU microspheres in conjunction with radiotherapy. Moreover, local relapses, tumour recurrence, occurred 20% less frequently in patients who received EP's novel treatment, which was well tolerated.

EP's novel product represents a new method of delivering localised and sustained 5-FU to the brain. Biodegradable microspheres containing 5-FUare implanted locally completely surrounding the surgical resection cavity, thus allowing the controlled-release of the compound directly into the brain tissue. The 5-FU acts as a local radiosensitiser, greatly improving the efficacy of the radiation therapy, which is normally used to treat this aggressive form of brain cancer. This new use of 5-FU has been possible because of EP's unique microsphere technology and represents a significant advance in the local control of residual cancer cells, which might remain once the tumour has been removed surgically.

Ethypharm is now planning the 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 has received "orphan drug status" for this product in the US (1999) and Europe (2000), providing seven and ten years exclusivity respectively in these key markets.

"These positive results using our novel implantable formulation of 5-FU are very encouraging for patients suffering from glioblastoma. The ability of our product to extend survival times by three months is a very significant improvement for a group of patients whose average survival time is less than one year," commented Patrice Debrégeas, CEO of EP.

Gérard Leduc, Managing Director and COO of EP added: "The ability of our implantable 5-FU microspheres to increase by three month the overall survival time of patients with glioma, opens up a significant market opportunity for this exciting new product. We are now looking for partners to help us get this new therapy for glioma to the market as quickly as possible."

Successful results for DDS microspheres in brain cancer
02 July 2003 - News Editor

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.