CellProtect Nordic Pharmaceuticals’ (CPNP) therapy candidate CellProtect has received orphan drug designation from the European Commission (EC) to treat multiple myeloma.
Manufactured from the patient’s own blood, CellProtect is said to be the first drug candidate consisting of autologous ex-vivo activated and expanded natural killer (NK) cells.
The company has performed a clinical phase I/II trial in patients with multiple myeloma where the drug has been studied as a supplemental treatment for autologous stem cell transplantation.
In the clinical trial, CellProtect showed a good safety profile and signals of efficacy.
CPNP is currently working on a clinical trial report to the Swedish Medical Products Agency, with plans to publish the results next year.
CellProtect Nordic Pharmaceuticals CEO Karin Mellström said: “The decision from the commission is based on a recommendation from the European Medicines Agency ‘s Committee for Orphan Medicinal Products and confirms that a future product is considered to be of significant benefit to those suffering from multiple myeloma.
“It also entails ten years of exclusivity upon marketing approval. We can now proceed and plan for additional clinical trials in order to receive approval to market CellProtect.”
CellProtect comprises the patient’s own NK cells, which the patented method of CPNP have been activated and expanded for so that they can recognise and attack cancer cells.
Research behind the drug has been performed at the Karolinska Institute in partnership with Karolinska University Hospital Huddinge in Sweden.