VIENNA, Oct. 21 /PRNewswire/ — Intercell AG (VSE; “ICLL”) and
Romark Laboratories L.C. today announced plans to commence clinical
trials of Intercell’s investigational therapeutic Hepatitis C virus
(HCV) vaccine, IC41, in combination with Romark’s antiviral drug,
nitazoxanide, during the first half of 2011.
Intercell’s vaccine candidate has demonstrated a sustained
reduction of viral load in chronic Hepatitis C (CHC) patients in a
Phase II proof-of-concept trial. Nitazoxanide is an oral therapy
that targets host cell factors involved in HCV replication and is
not associated with viral mutations conferring resistance.
Nitazoxanide has been shown to induce sustained virologic response
as monotherapy in some patients chronically infected with HCV.
The planned European Phase II trial will include about 60
treatment-naïve patients chronically infected with HCV
genotype-1 in three treatment arms: (1) IC41 plus nitazoxanide, (2)
IC41 plus nitazoxanide and Pegasys® (peginterferon alfa-2a) and
(3) Pegasys and Copegus® (ribavirin), the current standard of
care, as an active control. The primary endpoint will be sustained
virologic response (no detectable HCV RNA 24 weeks after
The companies involved in the combination study will retain
commercial rights for their respective products.
“We are very pleased about this important next step in the
development of our vaccine candidate against Hepatitis C. The
distinctly different mode-of-action and the outstanding
tolerability of both treatments create a joint approach in a field
that will continue to have high unmet medical need over the next
decades,” stated Gerd Zettlmeissl, CEO of Intercell.
“We are excited about this novel therapeutic approach for
chronic Hepatitis C,” said Jean-Francois Rossignol, M.D., Ph.D.,
Chairman and Chief Science Officer of Romark. “There is an
important need for novel therapies that offer improvements in
safety and efficacy com