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news.BioMS Medical, a biotechnology company involved in the treatment of multiple sclerosis, has announced that the FDA has granted fast track designation for the company's lead drug, dirucotide, for the treatment of secondary progressive multiple sclerosis.
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Dirucotide (MBP8298) is currently being evaluated in a US pivotal Phase III trial, named Maestro-03, at 68 sites with approximately 510 patients.
Kevin Giese, president and CEO of BioMS Medical, said: “Our receipt of fast track designation for dirucotide in the US is a significant milestone for both BioMS Medical and the multiple sclerosis community.
“Based on previous clinical results, we believe dirucotide is well-positioned to become a first-in-class treatment for secondary progressive multiple sclerosis patients, a large patient population with very limited treatment options.”