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ARQL > SEC Filings for ARQL > Form 8-K on 4-Jun-2009All Recent SEC Filings

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Form 8-K for ARQULE INC


4-Jun-2009

Regulation FD Disclosure


Item 7.01 Regulation FD Disclosure.

This report updates information contained in an earlier press release relating to data on disease control rates published in an abstract at the 2009 Annual Meeting of the American Society of Clinical Oncologists (ASCO) and issued prior to the final presentation of preliminary data from an ongoing Phase 2 clinical trial. This trial is designed to evaluate the efficacy of ARQ 197 when used to treat a group of tumors associated with dysregulation of the Microphthalmia Transcription Factor (MiT).

As presented at the ASCO Annual Meeting, an overall disease control rate (objective responses and stable disease) of 64 percent has been observed in preliminary results from the trial. The disease control rates by MiT tumor type and the numbers of evaluable patients with each tumor type are as follows:

†          Alveolar Soft Part Sarcoma, 81%, 16 patients;

†          Clear Cell Sarcoma, 43%, 7 patients; and

†          Renal Cell Carcinoma, 40%, 5 patients.

In accordance with General Instruction B.2 of Form 8-K, the information in this section of this report shall not be deemed filed for the purpose of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference in any filing. The furnishing of this information does not mean that it is material or that disclosure of the information is required.

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