ArQule completes patient enrollment in ARQ 197 Phase 2 trial for non-small cell lung cancer

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Enrollment completed in Phase 2 trial in non-small cell lung cancer; Enrollment begins in Phase 2 trial in hepatocellular carcinoma

ArQule, Inc. (Nasdaq: ARQL) today announced that patient enrollment in a Phase 2 trial with ARQ 197 in non-small cell lung cancer (NSCLC) has been completed.

Approximately 160 patients were enrolled in the NSCLC trial, which is a randomized, double-blind trial comparing combination therapy with ARQ 197 and erlotinib against erlotinib and placebo in EGFR (epidermal growth factor receptor) inhibitor-naïve patients in second and third line settings, with the primary endpoint being progression-free survival. Final data from this trial is expected to be available in the first half of 2010.

The Company also announced that patient enrollment in a Phase 2 trial with ARQ 197 in hepatocellular carcinoma (HCC) has been initiated. The Phase 2 initiation follows the successfully completed evaluation of patients enrolled in a safety trial in this indication.

Approximately 100 patients with unresectable HCC who have failed one prior systemic therapy are expected to be enrolled in the HCC trial, which is a randomized, double-blind trial comparing patients treated with ARQ 197 to those treated with placebo, with the primary endpoint being time-to-progression.

Separately and as part of the HCC tumor program, a Phase 1 safety trial in HCC is being conducted with the combination therapy of ARQ 197 and sorafenib.

Additional trials with ARQ 197 are ongoing in MiT (Microphthalmia Transcription Factor)-associated tumors and pancreatic cancer. Patients, physicians and other healthcare professionals seeking additional information about these trials may call 1-800-373-7827.


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