BioMS Medical Corp. (MS.T) has received approval from the U.S. Food and Drug Administration to start a pivotal trial of its lead drug, MBP8298, a potential treatment for patients with secondary progressive multiple sclerosis, the company confirmed.
The Phase III trial will enroll about 510 patients and take about two years, said Kevin Giese, BioMS Medical's president and chief executive.
The company has already begun a Phase III trial of the drug in Canada and Europe, which will enroll about 550 patients.
Multiple sclerosis is a disease of the central nervous system, marked by such things as paralysis, blindness and cognitive impairment.
Shares of BioMS are halted in Toronto Friday. The stock last traded at C$3.48.
Kevin Giese, president and chief executive of BioMS Medical Corp. (MS.T), said the company submitted an application for the trial with the U.S. Food and Drug Administration last month, and the agency gave its consent relatively quickly.
That means BioMS will soon have two Phase III trials in secondary progressive multiple sclerosis, or MS.
He hopes to commence the U.S. trial, which will cost a total of about C$50 million, in the first half of this year. While the company does have the funds to initiate the study, it will eventually have to raise more to get it done, he added.
Giese also noted that the Alberta-based biotech is close to completing patient enrollment in the Canada/Europe MS trial, and that data from an interim analysis of the trial are due 16 months from now, which isn't that far off in biotech terms. This trial has passed six safety reviews by an independent board to date.
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