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Exelixis Presents Clinical Data Supporting the Safety and Initial Clinical Activity of XL228 in Chronic and Acute Leukemia
Date:6/13/2008

Compound Inhibits Mutant Forms of BCR-ABL That Cause Resistance to Current

CML and ALL Therapies

COPENHAGEN, Denmark, June 13 /PRNewswire-FirstCall/ -- Exelixis, Inc. (Nasdaq: EXEL) today reported preliminary phase 1 data from an ongoing trial of XL228 in patients with chronic myelogenous leukemia (CML) or Philadelphia chromosome-positive acute lymphocytic leukemia (Ph+ALL) who are resistant to or intolerant of the approved BCR-ABL inhibitors imatinib and dasatinib. XL228 is a small molecule inhibitor of BCR-ABL, SRC, and insulin-like growth factor type 1 receptor (IGF1R), which are associated with cancer cell proliferation, survival, and metastasis. The compound also potently inhibits the T315I mutant form of BCR-ABL, which is resistant to all currently approved inhibitors. Dr. Jorge Cortes, Professor of Medicine, Deputy Chair, Department of Leukemia, University of Texas, MD Anderson Cancer Center, Houston, Texas, and an investigator on the phase 1 trial, presented the data in a poster session (Abstract #1260) at the 13th Congress of the European Hematology Association.

Seventeen subjects have received at least one dose of XL228, of whom 16 had completed Cycle 1 as of May 15, 2008. The trial is evaluating a treatment cycle consisting of 4 weekly 1-hour IV infusions of XL228 at doses ranging from 0.45 mg/kg to 7.2 mg/kg. Thirteen of the 17 subjects (76.5%) have BCR-ABL mutations, including seven (41.2%) with the T315I mutation. At the 3.6 and 7.2 mg/kg doses (either as part of Cohorts 4 and 5 or through dose escalation from a previous cohort), all subjects have demonstrated stable or decreasing white blood cell counts. A CML patient with an F317L BCR-ABL mutation in lymphoid blast crisis experienced
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