OCT is happy to announce that the first patients’ cohort consisting of 10 patients with diagnosis of multiple sclerosis has been enrolled at the clinical sites participating in the study. Enrollment of first cohort was done in 6 weeks and was completed well ahead of time. This was a result of proactive work of the project team with the sites.
Multiple sclerosis (or MS) is a chronic condition that affects the central nervous system. Central nervous system (CNS) consists of brain, spinal cord and optic nerves – all or some parts of CNS may be damaged by the disease. Depending on the scale of this damage, disease may have more or less debilitating symptoms. In the mild cases, symptoms may include numbness in the limbs, but in severe cases, paralysis or blindness may develop. At the moment, there is no way to predict at the time when diagnosis is established, severity, progress or any symptoms with which disease will be manifested.
Today, a lot is being done to find and develop the drugs that would prevent progression of the disease, by making remissions last longer, or make complications less severe, and where possible completely treat the patients.
The drug that is being investigated under this clinical program is a combination of several oligopeptides that prevent one of the main pathogenetic mechanisms of the disease development and clinical progression. This study of an innovative drug has unique design that was developed by the OCT and study Sponsor. Study objectives include safety and efficacy parameters. The drug showed good tolerability and safety in healthy volunteers (part of the study that was also conducted by the OCT and was completed in accordance with the study plan) – this stage of the study has been conducted prior to the start of the patients’ enrollment.
Within this study OCT is responsible for all activities associated with the study performance – from the protocol design and writing, planning, sites’ selection, submission through study management, logistics, statistical analysis, and final report writing. With OCT, clients get not only our expertise within clinical development with the vast knowledge of range of the indications and therapeutics areas, but also invaluable regulatory expertise that helps to navigate easily and successfully in the challenging environment.