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news.Results from a phase IIa monotherapy study of Migenix's candidate, celgosivir, for the treatment of chronic hepatitis C virus infections show that the drug was well-tolerated with some evidence of antiviral activity.
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“This phase IIa study in hepatitis C patients with celgosivir as monotherapy, along with the safety and nonclinical synergy data generated to date, supports our combination therapy development strategy,” stated Dr Jim DeMesa, president and CEO of Migenix.
Dr DeMesa went on to say that the company expects to begin enrollment in a phase IIb study designed to evaluate celgosivir in combination with other therapies for the disease.
This phase IIa monotherapy trial was conducted at six clinical centers in Canada and enrolled 43 patients randomized to receive celgosivir orally at either 200mg once daily, 200mg twice daily or 400mg once daily for twelve weeks. The patients participating in the study were HCV genotype 1, a difficult-to-treat strain of hepatitis C, who were treatment naive or intolerant to interferon/ribavirin therapy.
The results of the study demonstrate that celgosivir was well-tolerated with generally mild to moderate, reversible side effects, no serious adverse events, and some indication of antiviral activity.