New PI/II CT for overexpressing cancers

Published: 26-Nov-2003

Medarex announces phase I/II clinical trial development of MDX-214 for the treatment of EGF-R overexpressing cancers


Medarex announces phase I/II clinical trial development of MDX-214 for the treatment of EGF-R overexpressing cancers

An Investigational New Drug (IND) application has been filed by Medarex with the FDA to initiate Phase I/II clinical trials of MDX-214 to treat patients with cancers that overexpress the epidermal growth factor receptor, or EGFr. MDX-214 consists of recombinant human epidermal growth factor (EGF) genetically linked to a fully human antibody fragment that is designed to activate cytotoxic killing of cancer cells by immune effector cells. An open-label, dose- escalation Phase I/II study is expected to accrue up to 48 patients with refractory or relapsed EGFr-expressing cancers, including cancers of the head and neck, breast, colon, prostate, lung and ovary.

'We believe that MDX-214 is an innovative approach for the potential treatment of EGFr-expressing cancers,' said Donald L. Drakeman, president and ceo of Medarex. 'MDX-214 is designed to not only disrupt the EGFr signaling pathway and inhibit tumor cell growth but also to recruit killer immune cells to the tumor site.'

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