arqule inc (ARQL) Key Developments
ArQule Announces Interim Phase 2 Study Results for Tivantinib in Combination with Cetuximab in Patients with MET-High, KRAS Wild Type Colorectal Cancer
Jul 6 15
ArQule Inc. announced interim data from an ongoing investigator-initiated Phase 2 clinical trial with tivantinib in combination with cetuximab in patients with MET-High, KRAS wild-type metastatic colorectal cancer (CRC) NCT01892527 who recently progressed on anti-EGFR antibodies. These data were presented on July 3rd at the European Society of Medical Oncology (ESMO) World GI 2015 (abstract number O-008) by Dr. Lorenza Rimassa, MD, Deputy Director, Medical Oncology Unit at Humanitas Cancer Center, in Rozzano (Milan, Italy). The primary endpoint of the trial is ORR in the biomarker defined population. Secondary study endpoints are progression-free survival (PFS), overall survival (OS) and safety. The ESMO World GI presentation included data from 21 patients enrolled in Stage 1 of this trial. One patient, still on therapy, experienced a complete response (CR) and 2 patients experienced durable confirmed partial responses (PRs). Stable disease was observed in 8 patients, including 2 short duration PRs, for an overall Disease Control Rate (CR + PR + SD) of 52.4%. Having met the Stage 1 endpoint (=2 confirmed responses), the trial continued to Stage 2 and has recently completed enrollment. Adverse events were in line with those historically reported, including skin toxicity attributed to cetuximab, and neutropenia attributed to tivantinib. Neutropenia was addressed timely with growth factors and dose adjustments. The trial is a 2-stage, investigator-initiated study testing tivantinib plus cetuximab after recent progression on anti-EGFR antibodies. The trial is coordinated by the Humanitas Cancer Center in Milan, Italy. Stage 1 enrolled 21 patients, and Stage 2 recently completed enrollment of 20 additional patients. Final results from the 41 patients enrolled are expected by the end of 2015.
ArQule Inc. Appoints Robert J. Weiskopf as Chief Financial Officer
Jun 1 15
ArQule Inc. announced that Robert J. Weiskopf has been appointed chief financial officer. Mr. Weiskopf was previously vice president of finance, corporate controller and treasurer of the company. He will retain the title of treasurer and continue to report to Paolo Pucci, chief executive officer of the company. Prior to joining the company in 2007, Mr. Weiskopf was chief financial officer of Aware Inc. from 2004 until 2006. Prior to that, Mr. Weiskopf was director of finance at Lightbridge Inc. from 2000 to 2004.
ArQule Inc. Presents at Jefferies 2015 Global Healthcare Conference, Jun-03-2015 10:30 AM
May 27 15
ArQule Inc. Presents at Jefferies 2015 Global Healthcare Conference, Jun-03-2015 10:30 AM. Venue: The Grand Hyatt Hotel, New York, New York, United States.
ArQule Inc. Reports Unaudited Consolidated Earnings Results for the First Quarter Ended March 31, 2015
May 6 15
ArQule Inc. reported unaudited consolidated earnings results for the first quarter ended March 31, 2015. For the quarter, research and development revenue was $2.785 million against $2.676 million a year ago. Loss from operations was $4.815785 million against $7.305 million a year ago. Net loss was $4.551 million or $0.07 per basic and diluted share against $7.141 million or $0.11 per basic and diluted share a year ago. The revenue increase is primarily due to lower contra-revenue from Daiichi Sankyo tivantinib program.
ArQule Inc. and Beryllium Discovery Corp. Announce Collaborative Research and Development Agreement
May 5 15
ArQule Inc. and Beryllium Discovery Corp. announced a collaborative research and development agreement to identify and unlock the therapeutic potential of small molecule compounds by combining ArQule’s chemistry and drug development expertise with Beryllium’s discovery platforms. The Beryllium platforms integrate structure-guided drug discovery, biophysics and cell biology. The therapeutic targets to be pursued by the parties include PD-1 (programmed cell death protein 1) and PDL-1 (programmed death ligand 1), two proteins believed to play major roles in suppressing or limiting the response of the immune system. Molecules that bind to and inhibit the effects of these targets may help direct the immune system to combat a variety of tumors.