ArQule prepares to begin clinical trials of ARQ 171; data will contribute to package for Roche

By Jennifer Lanning Drey

Portland, Ore., Nov. 2 - ArQule Inc. has filed an Investigational New Drug Application for ARQ 171, its second-generation E2F1 compound, and expects to begin a phase 1 clinical trial of the drug before the end of the year, chief executive officer Dr. Stephen A. Hill said at the Mass Opportunities biotechnology investment conference in Boston on Thursday.

Data from the phase 1 study, along with data from phase 2 clinical trials currently underway with ArQule's lead E2F1 compound ARQ 501, will be used to create a data package for Roche to use to decide whether it will license the E2F1 Activated Checkpoint Therapy platform in the future.

The companies are currently developing the platform together under an agreement made in 2004 that gives Roche the option of licensing the program.

If Roche does chose to license the Activated Checkpoint Therapy program, the company will fund future phase 3 studies of the E2F1 compounds, plus the marketing and launch of related products.

"I think we've put ourselves in a very strong position with the deal we've put in place with Roche," Hill said.

He also said that ArQule has started patient enrollment in three phase 2 clinical trials of ARQ 501. Two of the trials will study ARQ 501 as monotherapy - one in leiomyosarcoma patients and the other in head and neck cancer patients. The third ARQ 501 trial will study the compound in combination with gemcitabine as a treatment for pancreatic cancer.

ArQule expects to end the year with $85 million to $90 million of cash, which will fund operations through mid 2008, Hill said.

ArQule could receive up to $276 million in milestone agreements under the agreement with Roche, Hill added.

Based in Woburn, Mass., ArQule researches and develops small-molecule cancer therapeutics.

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