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Romark reports promising data from hepatitis C virus study

Romark Laboratories, a privately held biopharmaceutical company, has announced encouraging results from international Phase I and II clinical trials evaluating a controlled release version of nitazoxanide in the treatment of chronic hepatitis C virus infection.

In the Phase II study in treatment-naive patients infected with hepatitis C virus (HCV) genotype 4, 82% (n=17) and 100% (n=16) of patients receiving low and high doses of controlled release nitazoxanide, respectively, experienced undetectable serum HCV RNA (<12 IU/mL) after 12 weeks of combination therapy with peginterferon and ribavirin.

In the Phase I study, Optima HCN-1, a total of 12 healthy adult volunteers were enrolled to evaluate pharmacokinetics following oral administration of nitazoxanide at 675mg or 1,350mg twice daily with food for seven days. This was a randomized, double blind crossover study.

According to the company, the 675mg and 1,350mg twice daily doses of controlled release nitazoxanide produced trough plasma concentrations of tizoxanide, the active metabolite of nitazoxanide, that were approximately 3x and 12x the trough concentrations observed in historical studies using a standard nitazoxanide 500mg tablet. Controlled release nitazoxanide showed favorable safety and tolerability throughout the course of the study, with mild to moderate adverse events (primarily GI-related) reported.

In a subsequent Phase II study, Optima HCN-2, a total of 41 treatment-naive patients with chronic hepatitis C genotype 4 were randomized to receive nitazoxanide at 675mg (n=17), nitazoxanide at 1,350mg (n=16) or placebo (n=8) twice daily for four weeks followed by the same regimen plus standard of care with peginterferon alfa-2a and ribavirin for 36 weeks (48 weeks for the placebo arm).

Interim virologic response rates are as follows: for the low and high-dose nitazoxanide arms, rapid virologic response (RVR, HCV RNA<12 IU/mL after four weeks of combination therapy) 59% and 63% respectively, compared with 50% for the placebo group; complete early virologic response (cEVR, HCV RNA<12 IU/mL after 12 weeks of combination therapy) 82% and 100%, respectively, compared with 63% for the placebo group; early virologic response (EVR, greater than or equal to 2 log10 decline in HCV RNA after 12 weeks of combination therapy) 88% and 100%, respectively, compared with 63% for placebo. In this study, a dose-related decline in serum HCV RNA was observed beginning on day four of combination therapy and was maintained through week 16.

Jean-Francois Rossignol, director of the Romark Institute for Medical Research, said: These data show that controlled release nitazoxanide exhibits favorable pharmacokinetics and tolerability, and – in combination with the standard of care therapy – robust antiviral activity in a small number of patients with HCV genotype 4. We look forward to reporting interim data from our US studies evaluating the standard nitazoxanide tablet in patients with chronic hepatitis C genotype 1 later in 2009.