New collaborator in vaccine game
Vienna – Austrian vaccine specialist Intercell AG has landed a new partner for its therapeutic vaccine IC41 against chronic infections with the hepatitis C virus (HCV) after Novartis quit a a 270m partnership with the firm this summer. In October, the company announced it will begin working with Florida-based Romark Laboratories L.C. in clinical development. Clinical Phase II trials that are expected to be initiated in the first half of 2011 will focus on testing a combination of Intercell’s therapeutic peptide vaccine with Romark’s antiviral thiazol compound nitazoxanide in 60 treatment-naive patients. The endpoint of the study – “no detectable HCV RNA 24 weeks after end-of-treatment”– will be determined in three study arms: IC41+nitazoxanide, IC41+nitazoxanide+ peg-interferon a2a (Pegasys®) and the current treatment standard Pegasys®+ ribavirin.
In a previous proof-of-concept Phase II trial with 50 previously untreated patients, Intercell says IC41 had achieved “viral load reductions of more than 75 % in patients with high baseline RNA levels for at least 6 months.” IC41 consists of five synthetic peptides (IPEP83, 84, 87, 89, 1426) harbouring CD4 and CD8 T-cell epitopes of HCV and the synthetic adjuvant poly-L-arginine.