Ark's Cerepro meets primary endpoint in Ph III trial; shares soar 69%

Ark Therapeutic's shares soared 69% to 80.25 pence after the UK firm reported strong late-stage trial results on its lead drug candidate. On July 30, the company saw massive gains on the London Stock Exchange after it said that a preliminary analysis of Study 904, a Phase III trial of its adenoviral-mediated gene-based agent Cerepro for operable primary malignant glioma, met its primary endpoint. In the overall combined controls primary endpoint analysis, the Intention-to-Treat population compared Cerepro with and without Schering-Plough's best-selling brain cancer drug temozolomide against controls with and without temozolomide and found that Ark's drug showed a 42-day improvement in median survival (310 days versus 268 days), and the improvement over standard care reached significance (p<0.032). Study 904 was a multicenter, standard-care controlled, pivotal trial, designed following advice from European regulators.