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FDA puts partial hold on zalutumumab trials

June 4, 2009 12:33 AM UTC

Genmab A/S (CSE:GEN) said FDA placed two clinical trials of zalutumumab to treat head and neck cancer on partial clinical hold. Genmab said the agency requested an updated analysis of safety data, which the company plans to submit shortly. The trials include a Phase II trial in patients with incurable disease and a Phase I/II trial for first-line treatment in combination with chemo-radiation. The biotech said patients in the studies who are not experiencing serious adverse events may continue treatment; however, no additional patients may be enrolled. ...