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ArQule, Threshold get a bump off of PhIII SPA pacts with FDA

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At the beginning of this month ArQule ($ARQL) 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.

The upcoming Phase III for hepatocellular carcinoma--a common type of liver cancer--will enroll about 300 patients in 120 sites around the world. Shares of the biotech bounced about 9% on the news.

"We are mindful of the high unmet need among patients suffering from this disease, and we are proceeding with our partner, Daiichi Sankyo, toward the timely initiation of this trial," said Paolo Pucci, chief executive officer of ArQule.

The closely-watched cancer drug has had a star-crossed year. Back in the summer its Asian partner Kyowa Hakko had to halt enrollment on a cancer study after investigators spotted signs of lung disease in patients.

Threshold Pharmaceuticals, meanwhile, also got a badly needed bounce out of a SPA today. The biotech ($THLD) says that the U.S. subsidiary of its partner Merck KGaA landed a SPA agreement with the FDA for a late-stage study of TH-302 for pancreatic cancer.

Shares of Threshold were hammered last month after the developer said that TH-302 had missed a key secondary endpoint for overall survival in the Phase IIb study. The biotech said at the time that it planned to take what it had learned in the mid-stage program and adapt the Phase III study accordingly. Merck KGaA partnered on the program back in February, agreeing to pay $60 million in near-term cash in a $525 million licensing pact. 

"In light of the evolving landscape for the first-line treatment of patients with advanced pancreatic cancer, we are pleased with the FDA's agreement that the design and planned analysis of this study adequately address the objectives necessary to support a regulatory submission," said Threshold CEO Barry Selick. "Given that the Phase II clinical trial met its primary endpoint, which was presented earlier this year at the annual AACR and ESMO medical meetings, we and our partner Merck are looking forward to further investigating TH-302 in a Phase III study in patients living with this extremely difficult to treat cancer."

- here's the release from ArQule
- read the release from Threshold

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