Battered ArQule shares bump up on badly needed positive data for tivantinib

ArQule's badly battered shares ($ARQL) managed a quick surge this morning on news that the biotech's lead drug tivantinib scored a positive outcome in a Phase II metastatic prostate cancer study. Investigators reported that patients in the MET-inhibitor arm of the study hit the primary endpoint for progression-free survival compared to a placebo.

The Woburn, MA-based biotech--which has been dogged by doubts and past failures with this drug--says the study produced "highly statistically significant" results, though the actual data will be held for an upcoming scientific meeting.

The company's stock jumped about 10% on the news, but it has been in steady decline since early this year, when the biotech announced that a reduced dosage of the drug was able to reduce incidents of neutropenia among patients while maintaining patients' plasma exposure to the treatment.

ArQule badly needs some wins in the clinic. Tivantinib failed a late-stage study for non-small cell lung cancer as well as an attempt on colorectal cancer in combination with Erbitux. In the meantime Daiichi Sankyo bowed out of its partnership. Their stock is trading at around $1.17 this morning, and its market cap is at a bargain-basement level: $72 million.

Paolo Pucci

"We are pleased that these significant findings from the NIH trial in prostate cancer add to the body of clinical evidence of the anticancer activity of tivantinib across multiple tumor types," said Paolo Pucci, chief executive officer of ArQule, in a statement. "Our CRADA reflects our shared commitment with the NCI to continue to explore the clinical potential of tivantinib in tumor types beyond the compound's lead indication, hepatocellular carcinoma (HCC), currently in Phase III clinical trials."

- here's the release

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