Ark Therapeutics announces completion of test

Ark Therapeutics has announced the completion of work to qualify a potency test for its product Trinam.

The company said it can now commence the gaining of a patent for the product, which is going into its phase III trial.

Used to prevent the blockage of blood vessels in kidney dialysis patients who have undergone vascular access graft surgery, the novel gene-based medicine is an adenovirus-mediated VEGF D gene.

Trinam has already been granted Orphan Drug Status in Europe.

Its phase III studies are a multi-centre, controlled and randomised trial, which aims to judge the safety and efficacy of the product in patients with end-stage renal disease who require vascular access for haemodialysis.

Dr David Eckland, research and development director of Ark, said: “Qualifying and validating batch release assays in advanced biologicals is pioneering work and is part of the evolving process of developing and improving the quality controls for these breakthrough drugs as they move nearer to market.”

Earlier this month, the company said its Cerepro novel gene-based therapy for the treatment of brain cancer has received approval by the European Medicines Regulatory Authority (EMEA).

Manufactured in Finland, the drug has Orphan Drug Status in Europe.