Coley Pharmaceutical Group Inc. has initiated a randomised phase II clinical study of Actilon (CPG 10101) for the treatment of patients with chronic hepatitis C infection.
The phase II clinical trial is expected to enrol ninety adults with genotype 1 hepatitis C virus (HCV) who have failed previous therapy with the current standard of care. Subjects will be randomly assigned to one of three parallel treatment arms, which will evaluate two dose levels of Actilon in combination with pegylated interferon alpha and ribavirin or pegylated interferon alpha plus ribavirin alone, states the company release.
The phase II clinical trial is designed to compare the safety and tolerability of the different drug combinations, as well as the efficacy of the regimens in reducing viral load over 12 weeks and achieving a sustained virologic response for 24 weeks following 48 weeks of treatment. Coley expects preliminary data from this phase II study to be available in the second half of 2006.
"This study is designed to determine how frequently the combination of Actilon plus standard of care induces early and sustained virologic responses in this population of chronic hepatitis C patients with a very high unmet medical need," said Robert L. Bratzler, president and CEO of Coley Pharmaceutical Group.
"Based on its promising safety profile, novel dual mechanism of action, which stimulates both the innate and adaptive arms of the immune system, and preclinical and phase I clinical studies data, we believe Actilon may prove to be an important component of both current and future therapeutic regimens in the treatment of chronic HCV," he added.
Subjects in each of the three arms will be treated for 12 weeks, at which time an early virologic response analysis will be conducted to assess reductions in serum HCV RNA concentrations. Those patients who achieve a greater than 1.5 log reduction in serum HCV RNA levels compared to baseline will continue treatment in their assigned regimen for an additional 36 weeks. Patients in the standard of care arm who fail to achieve a response may be offered the option of switching to one of the combination therapy arms. Subjects whose HCV RNA levels are undetectable at the end of 48 weeks will be monitored for an additional 24 weeks to determine if they have achieved a sustained virologic response.
Actilon is currently undergoing clinical evaluation both as a monotherapy and as part of combination regimens in an ongoing phase Ib clinical study among chronic HCV patients who have previously responded to standard treatment but have since relapsed. Preliminary results from a dose-escalation trial which evaluated Actilon's safety when administered as a monotherapy to HCV patients demonstrated that Actilon is generally well tolerated over a wide dose range, and induces dose-dependent antiviral and immune responses consistent with the known pharmacologic mechanisms of this new class of immunomodulatory antiviral drug candidates.
According to the World Health Organization, HCV infects approximately 170 million people worldwide, including at least 2.7 million in the United States.
Coley Pharmaceutical Group, Inc. is an international biopharmaceutical company that discovers and develops TLR Therapeutics, a new class of investigational drug candidates that direct the human immune system to fight cancers, infectious diseases, asthma and allergy.