EryDex
EryDex is a solution of dexamethasone sodium phosphate for encapsulation into human erythrocytes.
The Glucocorticoid analogues have in circulation a short half-life (about 4.5 h) and consequently they are administered in high doses, two or more times every day, with remarkable side effects. The possibility of providing to patients a minimal but constant plasma concentration of these drugs, would potentially increase their anti-inflammatory effects with concomitant reduction of the adverse effects. Based on these considerations the first drug loaded into red cells following this methodology has been Dexamethasone Sodium Phosphate (Dex 21-P).
Dexamethasone Sodium Phosphate (Dex 21-P), thanks to its phosphate group hydrophilicity, is retained into red blood cells until it is slowly dephosphorylated to its active diffusible form dexamethasone (Dex) which goes through the red cell membrane and is then released into circulation. The very slow dephosphorylation rate, suggests that the cells can perform as a dexamethasone slow releasing system in order to achieve the lowest but most effective maintenance dose.
As low as 50 ml of patient blood are used during the encapsulation procedure and they are immediately re-infused into the same patient at the end of the process in less than 2 hours.
The encapsulation procedure, thanks to the equipment and the disposable kit, is easily performed, reproducible and processed erythrocyte characteristics are almost identical to native ones. The plasma concentration curve shows that Dexamethasone is constantly released into plasma for many days after a single administration of 50 ml of drug-loaded erythrocytes at day zero.
The company has already tested EryDex in a number of successful pilot clinical investigations in different pathologies such as Cystic Fibrosis, Inflammatory Bowel Diseases and Chronic Obstructive Pulmonary Disease (see bibliography).
Even if the Dex 21-P EryDel’s encapsulation is currently adopted by some hospitals in Italy (“Bambin Gesù Pediatric Hospital” Rome, “Casa Sollievo della Sofferenza” San Giovanni Rotondo), the treatments are conducted under experimental trials (Ethics Committee approvals).
EryDel is now promoting a Clinical Trial involving nine European Hospitals (located in various part of Europe) in order to reach authorizations to commercialize the product. |
