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Exelixis Presents Encouraging Phase 1 Data For XL019, A Novel Selective Inhibitor of JAK2
Date:12/10/2007

erability of XL019 when administered orally once daily for 21 days in 28-day cycles. Secondary objectives include evaluation of the pharmacokinetics and pharmacodynamics of XL019, and to evaluate response using the International Working Group for MF consensus response criteria.

Results To-Date

Data (unaudited) from cohort 1 (100mg), cohort 2 (200mg) and cohort 3 (300mg) were presented today and the key findings by investigators include:

-- Preliminary clinical activity observed in most subjects, including:

- Reduction in spleen size of 33 to 100% in five of six patients

evaluated

- Reduction in erythropoietin-independent colony formation of up to

39% and up to 100% in two patients evaluated

-- Relief of constitutional symptoms, including pruritus, fatigue, back

pain and abdominal fullness

-- Reduction in the number of cells with the JAK2 V617F mutation (allele

burden)

-- Correlation between XL019 exposure and decreases in phosphorylation of

STAT, a marker for JAK activity.

-- XL019 was generally well tolerated.

- Adverse events included Grade 1 nausea, headaches, equilibrium

imbalance, dizziness, chest discomfort, visual disturbances, fatigue

and hypertension.

- Grade 2 AEs of lightheadedness and decreased sensation in soles and

one serious adverse event of confusion in a patient with baseline

history of dementia were also observed.

-- No evidence of myelosuppression

The maximum tolerated dose has not been reached. The phase 1 dose escalating clinical trial continues.

About JAK2 and XL019

JAK kinases are activated by cytokines and growth factor receptors and phosphorylate members of the STAT family of inducible transcription factors. JAK2 plays a pivotal role in the cellular response to growth factors that drive blood cell expansion, including erythrop
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SOURCE Exelixis, Inc.
Copyright©2007 PR Newswire.
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