Shares in Ark Therapeutics have risen sharply after the firm gave a positive update from a late-stage trial of Cerepro, its gene-based therapy for brain cancer.
The company said that the first update of the results of the Phase III trial showed the “main results strengthening in Cerepro’s (sitimagene ceradenovec) favour”. The study is looking at 236 patients with operable high-grade glioma being treated with Cerepro compared with standard care options. The latter involves surgery and radiotherapy, followed in some cases by treatment with temozolomide.
Ark says that 29 patients have still to reach a primary endpoint event (death or re-intervention), versus 53 in a previous report in July last year, of which 18 have been treated with Cerepro and 11 with standard care. The company added that the effect of the therapy on overall survival is, “as expected, complicated by the number of crossover therapies used after reintervention”.
However, Ark adds, the data show “increasing support for improved overall survival in patients receiving Cerepro after about 500 days with 56 patients in the trial still alive”. A marketing approval application was filed in Europe at the end of last year and Ark expects to hear from the European Medicines Agency’s Committee for Medicinal Products for Human Use in the fourth quarter.
In February, the company announced that the first named patient supply for Cerepro has been approved by the French Medicines Control Agency (AFSSAPS) following an application made by a neurosurgeon in the country.
