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Published on 6/6/2006 in the Prospect News Biotech Daily.

Exelixis says XL647 well-tolerated in phase 1 study for treatment of cancer

By Lisa Kerner

Charlotte, N.C., June 6 - Exelixis, Inc. said results from a phase 1 trial of XL647 in patients with advanced solid malignancies show that the orally bioavailable small molecule inhibitor of HER2, EGFR, VEGFR and EphB4 is well-tolerated, with evidence of biologic and clinical activity.

The company presented the results in a poster at the 42nd Annual Meeting of the American Society of Clinical Oncology in Atlanta.

A total of 40 patients have been treated across nine dose levels ranging from 0.06 to 7.0 mg/kg, in a liquid formulation and then a tablet formulation, Exelixis said.

One patient with non-small cell lung cancer (NSCLC) has had a partial response. Twelve others, with NSCLC (3), chordoma (2), adenoid cystic carcinoma (2), adrenocortical carcinoma, colorectal, ovarian, mesothelioma and head and neck cancer have had prolonged stable disease greater than 3.5 months.

Based on these results, Exelixis plans a phase 2 development program for XL647 later this year, officials said.

Patients with advanced solid malignancies received XL647 orally as a single dose on day 1, 5 continuous daily doses starting on day 4, dosing for 5 continuous days and then followed by a break with cycles repeated every 14 days until disease progression.

Exelixis is a biotechnology company located in South San Francisco, Calif.


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