-- The companies are designing a treatment that combines Intercell's investigational Hepatitis C vaccine, IC41, with Romark's antiviral drug, nitazoxanide.
-- A combination Phase II trial is expected to start in H1/2011.
-- The trial will be sponsored by Romark. Intercell will provide the vaccine candidate IC41.
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 end-of-treatment).
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 compared to current standard therapy. Our development program for nitazoxanide in combination with peginterferon addresses this need and promises to change paradigms for therapy of chronic Hepatitis C. The planned study of nitazoxanide in combination with Intercell's therapeutic vaccine further underscores our commitment to being a leader in the development of next-generation therapies."
Intercell's investigational therapeutic vaccine has been designed to restore an effective immune response against HCV, which ultimately is deemed necessary for sustained clearance of the virus. In a successful proof-of-concept trial involving around 50 treatment-naïve genotype-1 CHC patients, an optimized schedule of therapeutic vaccination achieved viral load reductions of more than 75% (0.6 log) in patients with high baseline RNA levels. Importantly, this reduction was sustained for at least six months following the end of treatment. As in previous trials with the vaccine from Intercell, vaccination was safe and well tolerated with minimal side effects.
Nitazoxanide, the first of a new class of broad-spectrum antiviral drugs called the thiazolides,(1,2,3) is an investigational new drug for CHC. It is a potent inhibitor of HCV in replicon studies,(2) and laboratory studies indicate that it does not induce viral mutations that confer drug resistance.(3,4) Nitazoxanide is synergistic with interferon and direct acting antivirals in replicon studies.(2,5) In a clinical trial of nitazoxanide monotherapy in patients with genotype 4 CHC, 17% (4 of 23) patients achieved sustained virologic response (undetectable serum HCV RNA 24 weeks after end of therapy), with all responders having low baseline serum HCV RNA levels (<400,000 IU/mL).(6) In other clinical trials, the addition of nitazoxanide to peginterferon or peginterferon plus ribavirin was associated with improvement in sustained virologic response rates without increasing the toxicities associated with peginterferon and ribavirin.(7,8) Romark is preparing to initiate Phase III clinical trials of nitazoxanide plus peginterferon for treatment of CHC.
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