Schering AG receives mixed trial results for growth factor drug

Schering AG has reported a mixed set of trial results for sargramostim, a growth factor drug being tested for use in Crohn’s disease.

In a phase III trial entitled novel 4, the drug demonstrated treatment benefits for patients with Crohn’s disease but failed to meet its primary endpoints involving disease response and remission at eight months.

However, a phase II trial called novel 2 showed that sargramostim was “significantly” more effective than a placebo in inducing corticosteroid-free clinical remission in normally corticosteroid dependent patients.

Despite the negative phase III results findings, Schering AG said it would drive forward with the development of sargramostim, which is already used in some countries in patients with acute myelogenous leukaemia.

Professor Marc Rubin, responsible for development and specialised therapeutics on Schering AG’s executive board, commented: “While we are disappointed that the novel 4 trial results did not uphold the significant outcomes observed in the Phase II induction trial (novel 1), the data did trend toward a treatment benefit with sargramostim.”

He added: “We are pleased that novel 2 did achieve a positive primary endpoint of steroid-free clinical remission. This study is the first randomised, double-blind, placebo-controlled trial conducted with any biological therapy in active steroid-dependent Crohn’s disease patients.”

In the UK, treatments like infliximab are used to treat Crohn’s disease, which affects approximately 60,000 Britons, according to the National Association for Colitis and Crohn’s Disease. It says that between 3,000 and 6,000 new cases are diagnosed every year and that the disease is sometimes associated with other inflammatory disorders affecting the joints, skin and eyes.

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