Gloucester Pharmaceuticals said yesterday that the FDA has approved its lead drug Istodax (romidepsin) for cutaneous T-cell lymphoma (CTCL), a rare skin malignancy. In a trial of 167 patients, 40 percent of participants on the drug experienced tumor size reduction. Gloucester says the drug will be commercially available in January 2010. This marks Gloucester's first drug approval.
The company's investors were confident Gloucester's drug would gain approval; recently the developer raised $29 million in a fourth round of venture capital. Novo A/S led, Apple Tree Partners, ProQuest Investments, Prospect Venture Partners and Rho Ventures all participated.
"The approval of ISTODAX is a tremendous accomplishment for Gloucester Pharmaceuticals and for the patients we serve," said Alan Colowick, Gloucester's CEO. "This milestone is also an important step in the continued clinical development path for ISTODAX in oncology. We look forward to presenting data from our registration study of ISTODAX in peripheral T-cell lymphoma in 2010 and continuing further investigation in additional hematologic indications and solid tumors."
- check out Gloucester's release
- read the Xconomy story