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www.fdanews.com/articles/72645-immunogen-reports-initial-findings-with-hun901-dm1-anticancer-compound

ImmunoGen Reports Initial Findings With HuN901-DM1 Anticancer Compound

May 24, 2005

ImmunoGen has reported favorable initial Phase II findings with its lead tumor-activated Prodrug (TAP) compound, huN901-DM1.

In the Phase II part of a Phase I/II study, huN901-DM1 demonstrated objective evidence of anticancer activity in the treatment of small-cell lung cancer, triggering expansion of the study to include additional patients, the company said. HuN901-DM1 is in development by ImmunoGen for the treatment of small-cell lung cancer and other cancers that express the CD56 antigen targeted by the compound.

In the Phase I, dose-escalation part of the study, huN901-DM1 was found to be well-tolerated at doses that demonstrate evidence of anticancer activity, as reported previously.

This Phase II study is designed to provide an initial assessment of the efficacy of huN901-DM1 in the treatment of patients with small-cell lung cancer. Patients with CD56-positive small-cell carcinoma also are eligible for enrollment. To qualify for enrollment, these patients need to have relapsed after previous treatment for their cancer.