Innovive’s cancer drug found effective against CML

In the study, Inno-406 was shown to be well tolerated and demonstrated activity in patients with chronic myelogenous leukemia (CML) who are intolerant or resistant to imatinib and multiple second generation tyrosine kinase inhibitors.

The first part of the Phase I, multi-center, open-label study was designed to find the maximum tolerated dose of Inno-406 and involved treating patients in escalating dose cohorts ranging from 30mg once daily (QD) up to 480mg twice daily (BID). Based on results from the first part of the study, Innovive has selected 240mg BID as the optimal dose to continue enrollment in an expansion cohort.

Among the 49 patients enrolled, Inno-406 was generally well tolerated. There were no grade 3/4 pleural effusions, peripheral edemas or pericardial effusions, and dosed patients experienced a low rate of hematologic toxicity and a minimal mean QTc effect. The efficacy data presented were from patients who participated in the dose finding portion of the Phase I study. Of the 20 evaluable CML chronic phase patients presented, three complete cytogenetic responses were seen including one in a patient intolerant to both imatinib and dasatinib.

Steve Kelly, president and CEO of Innovive, said: “These data support our belief that Inno-406 is a promising potential therapeutic treatment for patients unable to receive CML therapy after failing one or more tyrosine kinases including Gleevec.”