Biotech Values

[jellybean]

As previously reported, one patient treated at PEG-IFN-λ 1.5 μg/kg QW
+ RBV experienced reversible Grade 3/4 increases in ALT, AST, and bilirubin. No other patient receiving PEG-IFN-λ + RBV has experienced clinically-significant elevations in these parameters.

5 patients met protocol defined DLT criteria due to elevated hepatic lab values, one patient (3.0 mg/kg IFN QW, no ribavirin) had DLT of possible grade 3 idiopathic
thrombocytopenic purpura (ITP) considered possibly related to study drug
b Possible grade 3 idiopathic thrombocytopenic purpura considered possibly related to study drug
c Grade 3 hepatotoxicity (SAE), pruritus, and increased serum lipase/amylase without signs of pancreatitis, probably related to study drug, one patient in the 1.5 mg/kg QW IFN + ribavirin arm, pruritus at low levels seen across the dose range in combo with ribavirin
d Adverse drug reaction to meperidine (acute respiratory distress) in a subject with a history of migraine headaches and COPD, unrelated
to study drug