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Biotech / Medical : MEDX ... anybody following?
MEDX 31.58+1.4%Nov 5 12:44 PM EST
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From: Icebrg7/4/2007 2:48:49 PM
   of 2240
 
Phase I/II clinical and pharmacokinetic study evaluating a fully human monoclonal antibody against EGFr (HuMax-EGFr) in patients with advanced squamous cell carcinoma of the head and neck.

Radiother Oncol. 2007 Jun 27

Bastholt L, Specht L, Jensen K, Brun E, Loft A, Petersen J, Kastberg H, Eriksen JG.

Odense University Hospital, Denmark.

PURPOSE:
To assess safety, tolerability, pharmacokinetics and clinical activity of HuMax-EGFr in patients with SCCHN. PATIENTS AND

METHODS:
Twenty-eight patients with SCCHN were enrolled. The study comprised a single-dose escalation part for assessment of safety issues followed by a repeat dose extension including 4 weekly infusions at the same doses. Efficacy and metabolic response were evaluated according to RECIST by CT and FDG-PET.

RESULTS:
Most frequently reported adverse event was rash. All but one event were CTC grade 1 or 2 and a dose-dependent relationship was indicated. Duration of skin reactions varied from few days to 2months. No DLTs were observed and MTD was not reached. In the two highest dose groups, 7 of 11 patients obtained a PR or SD and 9 patients obtained metabolic PR or SD.

CONCLUSIONS:
HuMax-EGFr can be safely administered in doses up to 8mg/kg, and preliminary data on tumour response are encouraging.
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