>>ArQule Announces Tivantinib Meets Primary Endpoint, Significantly Extending Time to Progression in Phase 2 Trial in Second-Line Hepatocellular Carcinoma
WOBURN, Mass.--(BUSINESS WIRE)-- ArQule, Inc. (NASDAQ: ARQL - News) today announced that treatment with tivantinib as single agent therapy produced a statistically significant 56 percent improvement in time-to-progression (TTP) in the intent-to-treat (ITT) population, the primary endpoint in a randomized, controlled Phase 2 clinical trial in previously treated patients with hepatocellular carcinoma (HCC) (hazard ratio = 0.64; log rank p-value = 0.04).
Adverse events were reported at similar rates in the treatment and placebo arms, except for a higher incidence of fatigue and hematologic events, including neutropenia and anemia, in tivantinib-treated patients. The incidence of hematologic events declined following dose reduction of tivantinib from 360 milligrams twice daily (BID) to 240 milligrams BID.
“These findings represent the first randomized data reported with a c-Met inhibitor administered as a single agent in HCC,” said Dr. Brian Schwartz, chief medical officer of ArQule. “Second line treatment for HCC remains a challenge, lacking an approved agent. We look forward to presenting complete data from this trial at a peer-reviewed forum later this year, including secondary endpoint, sub-group and biomarker analyses.”
The 107 patients in this trial had unresectable HCC and had experienced disease progression after first-line therapy or were unable to tolerate such therapy. At the start of the study, patients were randomized to receive tivantinib at 360 milligrams BID or placebo. As previously disclosed, due to the rate of neutropenia, the tivantinib dose was reduced to 240 milligrams BID for all patients. TTP was defined as the time from patient randomization until objective tumor progression using RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria evaluated by central radiological review.
About Hepatocellular Carcinoma (HCC)
Hepatocellular carcinoma (HCC) is the most common primary cancer of the liver. The incidence is increasing, and HCC has risen to become the fifth most common malignancy worldwide and the third leading cause of cancer-related death, exceeded only by cancers of the lung and stomach.1 The estimated incidence is about 500,000-1,000,000 new cases per year, causing 600,000 deaths globally per year. Chronic hepatitis B and C are recognized as the major factors worldwide increasing the risk of HCC, with risk being even greater in the presence of co-infection with these viruses2. Cirrhosis is also a risk factor for development of HCC.
About c-Met and Tivantinib (ARQ 197)
Tivantinib is an orally available, selective inhibitor of c-Met, a receptor tyrosine kinase, which is currently in Phase 2 and Phase 3 clinical trials. In certain healthy adult cells, c-Met is present in low to normal levels to support natural cellular function and renewal, but in some cancer cells, c-Met is inappropriately and continuously activated. When thus abnormally activated, c-Met plays multiple roles in human cancer, including cancer cell growth, survival, angiogenesis, invasion and metastasis.
Pre-clinical data have demonstrated that tivantinib inhibits c-Met activation in a range of human tumor cell lines and shows anti-tumor activity against several human tumor xenografts. In clinical trials to date, treatment with tivantinib has been well tolerated and has shown clinical activity in the tumors studied.
About ArQule, Inc. and Daiichi Sankyo, Co., Ltd.
On December 19, 2008, ArQule and Daiichi Sankyo, Co., Ltd. signed a license, co-development and co-commercialization agreement to co-develop tivantinib in the U.S., Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea and Taiwan, where Kyowa Hakko Kirin Co., Ltd. has exclusive rights for development and commercialization.
Investor Conference Call
ArQule will host an investor conference call today at 9:00 a.m.
Date: Tuesday, January 17, 2011
Time: 9:00 a.m. Eastern Time
Conference Call Dial-In Numbers
Domestic: (877) 868-1831
International: (914) 495-8595
Confirmation code: 44134741
Webcast: investors.arqule.com
A replay of the conference call will be available beginning approximately two hours after its completion for seven days and can be accessed by dialing toll-free 1-855-859-2056 and 1-404-537-3406 from outside the U.S. For archived calls, the access code is 44134741.<<
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Stock is up nicely on this news, almost fireworking as I type.
Cheers, Tuck |
