Human Genome Sciences Inc., of Rockville, Md., presented final results of a Phase IIb trial of the investigational drug Albuferon (albinterferon alfa-2b) showing positive results among treatment-naïve patients, difficult to treat patients and for quality-of-life issues. For treatment-naïve patients, data showed that, with half as many injections as Pegasys (peginterferon alfa 2a), Albuferon was just as effective in achieving sustained virologic response, meaning an undetectable amount of virus in the blood at 24 weeks following the end of treatment. Albuferon is administered every two weeks, while peginterferon alfa-2a requires administration every week. The study also demonstrated that patients on Albuferon reported fewer missed days of work and less impairment of health-related quality-of-life issues in the Albuferon treatment group compared to the Pegasys (peginterferon alfa-2a) group. When tested on chronic hepatitis C patients who failed to respond to previous interferon-based therapy, Albuferon, administered at doses up to 1800 mcg every two weeks, had an acceptable long-term safety profile and produced an overall sustained virologic response rate of 17 percent. In the difficult to treat subgroup of genotype 1 chronic hepatitis C patients who previously failed to respond to treatment with pegylated interferon and ribavirin, Albuferon treatment produced an overall SVR rate of 11 percent.

In other developments reported at the American Association for the Study of Liver Disease meeting in Boston:

• Conatus Pharmaceuticals Inc., of San Diego, reported positive preclinical results for lead compound CTS-1027 in multiple models of hepatitis, showing that the drug significantly reduced liver damage following oral administration in four different models of liver injury. CTS-1027 markedly reduced aminotransferase activity and improved survival and liver histology in the TNFalpha/Gln model and was equally effective dosed at the same time as the insult or post-insult in the LPS/Gln model. Conatus is developing CTX-1027, a small-molecule matrix metalloproteinase inhibitor, for chronic use to protect the liver from damage due to a variety of insults, including virus infection, obesity, alcohol use and autoimmune diseases.

• Gilead Sciences Inc., of Foster City, Calif., said preliminary clinical data from an ongoing Phase I study of GS 9190, an investigational compound for the potential treatment of infection with the chronic hepatitis C virus showed single doses were well tolerated. The mean change in HCV RNA log copies/mL compared to baseline following administration for eight days was approximately -1.4 for the 40-mg dose and -1.7 for the 120-mg dose, compared to a negligible change in the placebo arm. Systemic clearance of drug at both doses was low, and pharmacokinetics were dose proportional. The median half-life of GS 9190 following multiple-dose administration was 10-13 hours. Twice-daily administration of GS 9190 over eight days at those doses was generally well tolerated. On the basis of the findings, Part B of the study (n=23) was initiated to evaluate multiple doses of the compound, administered over a period of eight days, in four successive cohorts: 40 mg BID, 120 mg BID, 240 mg QD and 240 mg BID. The study is expected to be concluded this year.

• Metabasis Therapeutics Inc., of San Diego, offered data from a preclinical study for MB07811, the company's clinical-stage, liver-targeted beta-subtype-selective thyroid hormone receptor agonist product candidate for hyperlipidemia. Metabasis' poster presented data demonstrating that oral administration of MB07811 to three commonly used animal models of diabetes and obesity, for two to nine weeks, resulted in marked reduction in liver fat (hepatic steatosis).

• Progen Pharmaceuticals Ltd., of Brisbane, Australia, announced additional data from the Phase II liver cancer study of PI-88 completed earlier this year. The analysis of patients who had a high risk of recurrence in the 12-month period shows that PI-88 at least doubled the time to disease recurrence calculated at the 60th percentile (p=0.0107) (control [n=33]: 24 weeks vs. 160 mg PI-88 [n=36]: 48 weeks). That compares to a 76 percent improvement at the 70th percentile (p=0.0867) if all patients are included, as reported earlier this year.