* Says drug showed 66 pct improvement in median PFS
* Shares more than double to 2-yr high
(Adds details, analyst comments and updates share movement)
By Anand Basu
BANGALORE, March 31 Biotechnology company
ArQule Inc (ARQL.O) said its lead experimental lung cancer drug
showed positive results in a mid-stage trial, sending its
shares up to a new two-year high.
The drug, ARQ 197, when used with another lung cancer drug,
erlotinib, showed a 66 percent improvement in median
progression-free survival (PFS) -- the time without cancer
growth or death -- in patients with advanced, refractory
non-small cell lung cancer, ArQule said.
"The drug is good to go into phase 3 trials, based on the
efficacy and safety results shown in phase 2 study," Needham &
Co analyst Mark Monane said.
The median PFS was 16.1 weeks in the ARQ 197 plus erlotinib
arm, compared with 9.7 weeks in the erlotinib plus placebo arm,
the company said in a statement.
"There were no clinically relevant differences in adverse
event rates between the treatment and control arms," the
The company, however, said the difference in PFS between
the two arms did not achieve statistical significance by
applying a log-rank test.
The mid-stage trial was a randomized, double-blind study,
where 71 patients were treated with the drug combination and 72
patients with a dummy pill combination.
Monane said the drug failed to achieve statistical
significance as the sickest patients were in the drug
combination arm. He said with a bigger late-stage trial the
randomization will not be an issue.
ArQule is co-developing the drug with Japan's Daiichi
Sankyo (4568.T) in the United States, Europe, South America and
the rest of the world, excluding Japan, China, South Korea and
Taiwan, where Kyowa Hakko Kirin (4151.T) has exclusive rights
for development and commercialization.
"The good news is they have partner Daiichi Sankyo and the
collaboration allows them to fund the project forward," he
Shares of the company were up 110 percent at $7.40 in late
morning trade Wednesday on Nasdaq. They touched a high of $7.49
earlier in the session.
(Reporting by Anand Basu; Editing by Unnikrishnan Nair)