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Biotech / Medical : MEDX ... anybody following? -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (769)	11/24/2003 6:08:37 AM
From: Icebrg	Read Replies (1) \| Respond to of 2240

Medarex Announces Phase I/II Clinical Trial Development of MDX-214 for The Treatment of EGF-R Overexpressing Cancers Monday November 24, 6:01 am ET Thirteenth UltiMAb(TM)-based Product to Enter Clinical Development PRINCETON, N.J., Nov. 24 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX - News) today announced the allowance of an Investigational New Drug (IND) application filed with the U.S. Food and Drug Administration (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." About MDX-214 MDX-214 is believed to target the epidermal growth factor receptor (EGFr), a receptor molecule implicated in tumor cell growth and found to be over- expressed in a variety of cancers, including head and neck, breast, colon, prostate, lung and ovarian cancers. Preclinical in vitro studies conducted by Medarex suggest that MDX-214 may provide an unusually potent approach to treating EGFr-positive cancers by inhibiting tumor cell growth and by mediating antibody-dependent cellular cytotoxicity (ADCC).