By Melodie Warner
Verastem Inc.'s (VSTM) lead cancer-stem-cell inhibitor, VS-6063, received the U.S. Food and Drug Administration's orphan drug designation for mesothelioma, a rare lung cancer.
The designation--created to encourage the development of drugs for rare diseases or conditions affecting fewer than 200,000 patients in the U.S.--provides for a seven-year period of market exclusivity after approval, FDA assistance in clinical trial design and an exemption from FDA user fees.
Verastem expects to enroll up to 400 patients at clinical sites in 11 countries for its clinical study of VS-6063, or defactinib, in patients with malignant pleural mesothelioma.
The cancer-drug developer last month said VS-6063 was granted orphan status by European regulators for mesothelioma, an asbestos-related cancer with limited treatment options.
The company recently completed Phase 1 of an ongoing Phase 1/1b study evaluating the combined use of defactinib with weekly paclitaxel for ovarian cancer.
Verastem also expects to initiate a Phase 2 trial during the third quarter for defactinib in KRAS-mutated non-small cell lung cancer.
Shares closed Tuesday at $15.91 and were inactive premarket. The stock is up 81% so far this year.
Write to Melodie Warner at melodie.warner@dowjones.com
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