RRMS study close-out meeting
GCT is proud to announce that Phase II clinical trial was successfully completed!
Last week Dr. Eugene Selivra, CEO, and Dr. Alexey Vinogradov, Project Manager, participated in the investigator meeting in Sochi, Russia devoted to the successful Phase II Multiple Sclerosis project completion. During the formal part of the meeting an overview of promising study results was given by the Sponsor and a dynamic discussion on the future application of the study drug took place. After the official part was over, all participants proceeded to a lavish gala-dinner organized by the Sponsor to celebrate the project success. Informal and very animated conversations continued, revolving around current standards of care, breakthrough therapies and market potential for the studied product.
The clinical trial was a 6-month, double-blind, randomized placebo-controlled multicenter Phase II Study studying safety and efficacy of the two dosages of the Investigational Product in treatment-naïve patients with relapsing-remitting multiple sclerosis (RRMS). 21 sites in Russia were actively recruiting patients during 9 months, reaching a total amount of 204 randomized subjects. All sites selected by GCT showed excellent quality of work, diligence and accuracy at all stages of the study. They demonstrate great recruitment potential and can boast large patient databases. Study team members are certified specialists with sufficient experience in clinical trials.
As a result, all predicted timelines were met and deliverables achieved according to the protocol schedule. Investigators expressed their willingness to participate in the further trials.
GCT is looking forward to a continuous successful cooperation with the Sponsor and Investigators in the future!
Updated: May 19, 2017