Saturday, January 12, 2013

ArQule shares tank after colorectal cancer study fails to meet main ...

Pdf Fri 11:51 am by Deborah Bacal

() shares plummeted Friday after the company, together with its partner Daiichi Sankyo Co, said a phase 2 colorectal cancer trial didn't meet the main survival goal.?

Shares in were down by over 15% this morning, to $2.48.?

The study showed the combined use of tivantinib with two other cancer-fighting treatments in patients with refractory or relapsed colorectal cancer didn't meet the survival targets.?

and Daiichi signed a co-development licensing agreement for tivantinib in the U.S., Europe, South America and the rest of the world, excluding Japan, China, South Korea and Taiwan, in 2008.?

The two pharmaceutical firms said Friday that 's lead product candidate, tivantinib, in combination with irinotecan and cetuximab, did not meet the primary endpoint of progression free survival.?

The study showed the median PFS was 8.3 months in the experimental arm, compared with 7.3 months in the control arm, or those treated just with with irinotecan and cetuximab, plus placebo.?

The objective response rate, the secondary goal, was 45 per cent in the experimental arm versus 33 per cent in the control arm, which isn't considered "statistically significant".?

The companies said that additional data and analyses from this trial are planned for presentation at a future medical meeting.

?We are encouraged by these findings that expand the body of data for tivantinib in CRC [colorectal cancer] and offer the potential for further exploration,? added VP of clinical development at Daiichi, Reinhard von Roemeling.?

?We plan to continue discussions with key opinion leaders in the field of CRC to determine how best to proceed with further clinical development of tivantinib in this tumor type.?

In October, and Daiichi Sankyo decided to discontinue their phase 3 clinical trial of tivantinib to treat nonsmall-cell lung cancer after an independent committee concluded the study wouldn't meet its primary goals of improved overall survival.

Source: http://www.proactiveinvestors.com/companies/news/39321/arqule-shares-tank-after-colorectal-cancer-study-fails-to-meet-main-goal-39321.html

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