GENMAB ANNOUNCES LIFT OF ZALUTUMUMAB PARTIAL CLINICAL HOLD
- Category: Antibodies
- Published on Thursday, 16 July 2009 03:00
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Genmab announced that the US Food and Drug Administration (FDA) has lifted the partial clinical hold on zalutumumab studies being conducted under an US Investigational New Drug application
Copenhagen, Denmark | July 16, 2009 | Genmab A/S (OMX: GEN) announced today that the US Food and Drug Administration (FDA) has lifted the partial clinical hold on zalutumumab studies being conducted under an US Investigational New Drug application. Enrolment of patients can now resume in the Phase II study in patients with head and neck cancer considered incurable with standard treatment and the Phase I/II front line study of zalutumumab in combination with chemo-radiation.
"We have worked diligently to meet the FDA's request for additional zalutumumab safety information and are pleased that enrolment in the studies can be resumed so quickly," said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab. "We continue to believe zalutumumab could provide an important new treatment option for head and neck cancer patients with unmet medical needs."
Zalutumumab is a high-affinity human antibody that targets the Epidermal Growth Factor receptor (EGFr), a molecule found in abundance on the surface of many cancer cells, and is a well validated target. Zalutumumab is in development to treat head and neck cancer and has received a Fast Track designation from the FDA covering patients with head and neck cancer who have previously failed standard therapies.