Romark and Intercell Join Forces in Combining Therapies Against Hepatitis C

TAMPA, Fla., Oct. 21 /PRNewswire/ -- Romark Laboratories, L.C. and Intercell AG (VSE; "ICLL") today announced plans to commence clinical trials of Romark's antiviral drug, nitazoxanide, in combination with Intercell's investigational therapeutic hepatitis C virus (HCV) vaccine, IC41, during the first half of 2011.

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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 approximately 60 treatment-naive 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 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."

"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 creates 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.

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-naive 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.

About Hepatitis C

Hepatitis C is a blood-borne infectious disease that is caused by the hepatitis C virus (HCV). It is the most common cause of chronic hepatitis in the U.S. and may eventually lead to cirrhosis, liver cancer and liver failure. The disease is transmitted by contact with HCV-infected blood.  A large majority of those infected do not show symptoms, but fatigue, abdominal pain and nausea can be common.  The current standard treatment of care, peginterferon and ribavirin, is effective in about half of all patients treated. Treatment outcomes vary based on a number of factors including genotype, viral load, genetic factors, stage of liver disease, co-infections and ability to adhere to treatment.  According to the Centers for Disease Control, HCV affects an estimated 3.2 million Americans.

About Romark Laboratories

Romark Laboratories, L.C. (www.romark.com) is a biopharmaceutical company committed to the discovery and development of innovative new small molecules for treating infectious diseases and cancers.  The Company is developing a new class of broad-spectrum antiviral drugs called the thiazolides. The first thiazolide, nitazoxanide, is an investigational new drug in late-stage clinical development for the treatment of chronic hepatitis C and influenza. Other new thiazolides are expected to enter clinical development in 2011.  Romark markets Alinia® (nitazoxanide) tablets, 500 mg and Alinia® (nitazoxanide) for Oral Suspension, 100 mg/5 mL in the United States.

About Intercell AG

Intercell AG is an innovative biotechnology company that develops novel vaccines for the prevention and treatment of infectious diseases with substantial unmet medical needs. Intercell's vaccine to prevent Japanese Encephalitis is the Company's first product on the market.

The Company's technology platform includes an antigen-discovery system and human anti-infective monoclonal antibody discovery system, adjuvants and a novel patch-based delivery system (Vaccine Patch, Vaccine Enhancement Patch). Based on these technologies, Intercell has strategic partnerships with a number of global pharmaceutical companies, including GSK, Novartis, Merck & Co., Inc., Sanofi-Aventis, and Pfizer (formerly Wyeth).

The Company's pipeline of investigational products includes a Travelers' Diarrhea Vaccine Patch (Phase III), a Pseudomonas vaccine candidate (Phase II), a vaccine to prevent Pandemic Influenza combining our Vaccine Enhancement Patch with an injected vaccine (Phase II), a vaccine program for S. aureus, which is being developed with Merck & Co., Inc. (Phase II/III), as well as a vaccine candidate for Pneumococcus (Phase I). In addition, further products focused on infectious diseases are in pre-clinical development.

Intercell is listed on the Vienna stock exchange under the symbol "ICLL" (U.S. level one ADR symbol "INRLY").

(1) Rossignol JF. Thiazolides: a new class of antiviral drugs. Expert Opin Drug Metab Toxicol. 2009;5:667-674.

(2) Korba BE, Montero AB, Farrar K, et al. Nitazoxanide, tizoxanide, and other thiazolides are potent inhibitors of hepatitis B virus and hepatitis C virus replication. Antivir Res. 2008;77:56-63.

(3) Korba BE, Elazar M, Lui P, et al. Studies of the potential for hepatitis C virus resistance to nitazoxanide or tizoxanide. Antimicrob Agents Chemother. 2008;52:4069-4071.

(4) Yon C, Viswanathan P, Rossignol JF, Korba BE. Resistance to nitazoxanide is associated with alterations in the host and not the virus in HCV replicon-containing cultures. Submitted for publication.

(5) Korba BE, Elazar M, Liu P, et al. Potential role for nitazoxanide in combination with STAT-C agents for the inhibition of HCV replication without the development of resistance. Hepatology. 2008;48(suppl):356A.

(6) Rossignol JF, Kabil SM, El-Gohary Y, Elfert A, Keeffe EB. Clinical trial: randomized, double-blind, placebo-controlled study of nitazoxanide monotherapy for the treatment of patients with chronic hepatitis C genotype 4. Aliment Pharmacol Ther. 2008;28:574-580.

(7) Rossignol JF, Elfert A, El-Gohary Y, et al. Improved virologic response in patients with chronic hepatitis C genotype 4 treated with nitazoxanide plus peginterferon alfa-2a with or without ribavirin. Gastroenterology. 2009;136:856-862.

(8) Rossignol JF, Elfert A, Keeffe EB. Treatment of chronic hepatitis C using a 4-week lead-in with nitazoxanide before peginterferon plus nitazoxanide. J Clin Gastroenterol. 2010;44:504-509.

SOURCE Romark Laboratories, L.C.

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