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Robert Forrester, CEO of Verastem
Verastem Inc. (Nasdaq: VSTM) has expanded its development reach to Japan with the beginning of an early-stage trial there of its lead candidate to treat mesothelioma.
The Cambridge-Based biotech announced Tuesday the beginning of a Phase 1 trial of defactinib, an inhibitor of focal adhesion kinase (FAK), a critical link in the chain of events in the growth and survival of cancer stem cells. While the trial will involve 12 to 18 patients with various kinds of advanced solid tumors, defactinib began a Phase 2 trial in the U.S. two weeks ago specifically aimed at malignant pleural mesothelioma, an aggressive form of lung cancer with no currently approved treatments. That trial will involve up to 400 patients, and if the candidate is shown to be effective enough, will form the basis for an application for U.S. approval by 2016 at the earliest.
The company said in a statement that pending the outcome of the new Phase 1 trial, additional sites in Japan may be added to the global Phase 2 trial against mesothelioma.
“Initiation of this trial is another important clinical milestone for Verastem and for defactinib, a drug candidate which is now being studied at sites in 12 countries over five continents,” said Joanna Horobin, Verastem’s chief medical officer, in a statement. “In the U.S. Phase 1 study, defactinib demonstrated good tolerability, as well as early signs of activity. With this study we hope to take the first steps toward a path to registration in Japan in parallel to our efforts in Europe and the US.”
The company went public last year, and its stock was up more than 4 percent to $13.38 a share on Tuesday on the news of the Japanese trial. Shares are up a total of 30 percent for the year so far.
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