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Data on MS 'vaccine' Xemys released (05/04/16)

PJSC Pharmsynthez, a pharmaceutical company based in Russia, has announced completed follow-up findings and data analysis from a Phase 2a proof-of-concept clinical trial of its therapeutic vaccine Xemys for the treatment of multiple sclerosis (MS).

In the open-label, dose-escalating trial, 20 patients with a diagnosis of relapsing-remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS) were treated weekly with ascending doses of Xemys for a period of six weeks. The maximum dose was 2.675 mg.

Enrolled patients had “meaningful” disease activity.

Before the first injection of Xemys, during the treatment period, and after 17 weeks of follow-up, all patients were clinically assessed through magnetic resonance imaging (MRI), expanded disability scale score (EDSS), and levels of serum cytokines.

Injections of Xemys were found to be well-tolerated in patients who had previously not achieved a sustained control of their condition. Patients experienced mild or moderate adverse events related to treatment with Xemys, and these were found to occur mostly with submaximal and maximal dosing. No concomitant medication was required to manage the adverse events.

Twenty weeks after study enrollment, seven patients (37 per cent) had no evidence of disease activity as measured by NEDA (No Evidence of Disease) scores, and 16 patients (85 per cent) were free of relapse. Only three patients experienced relapses during the trial. There were statistically meaningful increases in the number of gadolinium-enhancing lesions, but these were only evident in patients who had experienced disease relapse.

Source: Multiple Sclerosis News Today (05/04/16)