COLEY SUSPENDS HEPATITIS C PROGRAM

Coley Pharmaceutical announced it has decided to suspend the development of Actilon, its product candidate for the treatment of hepatitis C virus (HCV) infection. The decision was reached based on clinical data obtained from two separate but concurrent clinical trials evaluating Actilon for use among treatment-refractory patients with genotype 1 HCV.

One trial was a 12-week Phase Ib clinical study of Actilon in various combinations with pegylated interferon and ribavirin. Among previously treated relapsed patients, the triple combination was generally well tolerated. At 24 weeks on therapy, seven of 14 patients receiving Actilon remained HCV viral negative. These patients completed 48 weeks of therapy by year-end 2006 and were followed to determine if a sustained virologic response, defined as continued viral clearance for six months after cessation of treatment, was achieved. Recently, the company reported that two of the seven patients remained HCV viral negative at one and four months, respectively, following the cessation of treatment.

The other was a 48-week, three-arm Phase II clinical trial of Actilon in combination with pegylated interferon and ribavirin in the null and partial-responder treatment-refractory patient population. Coley reported that no meaningful differences in viral load reduction were observed in any of the treatment arms in the null patient population.

"Coley adopted a speed-to-market strategy by evaluating Actilon in the treatment-refractory HCV patient population. The data generated to date shows the need for Coley to capture a portion of the naive patient population to maximize its commercial opportunity in HCV," Robert Bratzler, president and CEO of Coley, said. "However, the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk. We have made the decision to mitigate risk by suspending further investment in Actilon until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear."