UPDATE 2-ArQule cancer drug shows promise; shrs more than double

Wed Mar 31, 2010 11:39am EDT

* 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 (Reuters) - 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 company said.

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 said.

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)

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