Massachusetts biotech ArQule has gotten word from its data monitoring committee that its Phase III trial of tivantinib is doing fine despite a dosing reduction that once threatened to derail its development, stoking hopes that the company can finally get its liver cancer treatment across the goal line and sending shares up nearly 30%.
ArQule watched its shares scrape the bottom last fall when it pulled the plug on a late-stage lung cancer drug, but rumors that the Woburn, MA, company is primed to release data that could revive tivantinib sent its stock price up as much as 19% on Friday.
After a pair of trial setbacks with a separate program from ArQule, Japan-based drugmaker Daiichi Sankyo has decided to jettison an alliance with the Woburn, MA-based drug developer on an early-stage compound known as ARQ 092.
ArQule ($ARQL) suffered another failure with its top anti-cancer contender tivantinib. This time the experimental kinase inhibitor fell short in a midstage study in patients with aggressive cases of colorectal cancer, a fresh setback in a program already injured from efficacy concerns.
At the beginning of this month ArQule shares tanked on the news that it had decided to shelve a late-stage study of tivantinib for non-small cell lung cancer after investigators concluded that the data pointed to a clear failure. But today the biotech got a little of its lost luster back with the news that it had agreed with regulators on the design of a new Phase III, landing a special protocol assessment on its program for liver cancer.
ArQule and its partner Daiichi Sankyo revealed some depressing news about their late-stage program for the closely watched cMET inhibitor called tivantinib or ARQ 197 in patients with non-small cell lung cancer.
Shares of ArQule ($ARQL) plunged this morning after its Japanese partner on the closely-watched cancer drug tivantinib alerted the biotech that it temporarily suspended enrollment in its Phase III trial for non-small cell lung cancer after spotting signs of lung disease in patients.
Any forward-looking student of the biotech industry will have to check out Adam Feuerstein's review in TheStreet of 22 Phase II and III clinical trials--21 drugs and one diagnostic test--which are expected to read out by the end of this year.
Later this week the cancer drug research crowd will examine a tsunami of abstracts filed ahead of the ASCO meeting in early June in the hopes of finding a few gems.
Shares of ArQule ($ARQL) spiked more than 20 percent this morning after the biotech announced that its lead drug tivantinib achieved significant results in time-to-progression for patients suffering