Pivanex problems in Phase IIb
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Titan discontinues the Pivanex plus docetaxel arm of its Phase IIb non-small cell lung cancer study after an interim analysis identifies "significant safety issues" with combination treatment. Prior single-agent Phase I and Phase II studies and a dose-ranging study of the combo did not reveal toxicity issues, the firm says. Other arms in the NSCLC study will continue, but Titan will withhold further treatment and enrollment in open-label Phase IIa studies in chronic lymphocytic leukemia and melanoma "until further analysis of the data from the Phase IIb study is available." Pivanex inhibits histone deacetylases, a class of enzymes involved in cell growth...