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Robert Forrester, Verastem president and CEO
A month after Verastem Inc. (Nasdaq: VSTM) got orphan drug designation in Europe for its potential drug to treat a rare form of lung cancer, the Cambridge biotech received the same designation in the U.S.
The designation for VS-6063 as a treatment for mesothelioma could mean a faster approval process for the drug and a longer period before competition from generic versions of the drug. It is granted to investigational drugs that address rare diseases for which there is no current treatment.
The Cambridge, Mass., biotech develops cancer drugs that work by targeting cancer stem cells. VS-6063 was acquired a year ago from Pfizer after it had already undergone Phase 1 trials to test for safety against several types of cancers. Verastem since discovered it to be effective against mesothelioma, a cancer for which there is only one approved treatment in the U.S.
“Mesothelioma is among the most aggressive and lethal cancers but has limited treatment options,” said President and CEO Robert Forrester in a statement. “We are pleased that the FDA recognizes the significant unmet medical need in mesothelioma."
The candidate is set to begin clinical trials this summer, and the company is developing a biomarker test in conjunction with LabCorp to identify a subgroup of patients who would best benefit from the potential treatment. VS-6063 is also in a Phase 1/1B trial in combination with an approved drug against ovarian cancer.
The company has said that a Phase 2 trial set to begin before the end of the year may qualify as the pivotal trial and form the basis of an application for its approval.
Verastem was founded in 2010, and raised $55 million in its initial public offering in January 2012.
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