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Biotech / Medical : CRIS, Curis (formerly CBMI)
CRIS 1.4800.0%3:59 PM EDT
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To: Arthur Radley who wrote (664)9/3/2009 9:10:18 AM
From: Arthur Radley   of 668
 
8:01AM Curis announces GDC-0449 Phase I clinical data published in New England Journal of Medicine (CRIS) 2.10 : Co announces that two publications describing clinical data generated with GDC-0449 were published in the current edition of The New England Journal of Medicine. The first publication provides an overview of the Phase I data for the 33 basal cell carcinoma (BCC) patients treated in this study. The second paper provides an overview of the treatment of a single adult medulloblastoma patient with GDC-0449. In 18 patients with metastatic BCC, 8 patients had confirmed partial responses (7 by RECIST and 1 by clinical assessment), 1 patient had an unconfirmed partial response by RECIST, 7 patients had stable disease as a best response and 2 patients had progressive disease. The overall response rate was 50% (9 partial responses out of the 18 metastatic BCC patients in the study). The overall response rate was 60% (2 complete responses plus 7 partial responses out of the 15 locally advanced BCC patients in the study). Pharmacokinetics (PK) and Pharmacodynamics (PD)GDC-0449 demonstrated a favorable PK and PD profile with a median steady-state plasma concentration of 16.1 micromolar. The median time to reach this steady-state level was 14 days. Dose escalation from 150 mg to 270 mg did not result in higher total plasma concentrations of GDC-0449 and as a result, Genentech has selected a daily dose of 150 mg for the ongoing Phase II clinical trials.
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