In June 2012, Innate Immunotherapeutics completed a Phase 1B/2A (dose escalation/dose confirmation) trial MIS416 in patients with the progressive forms of Multiple Sclerosis (MS). The study was conducted with financial support from the U.S. National MS Society and the New Zealand Government.
The design of the study was summarized as follows:
A Phase 2, open-label, dose-escalation study evaluating the safety, tolerability, and pharmacodynamics of intravenously administered MIS416 in patients with chronic progressive multiple sclerosis
1.To determine the safety and tolerability, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of intravenously (IV) administered MIS416 weekly in patients with chronic progressive multiple sclerosis (CPMS); and
2. To assess the pharmacodynamic (PD) effects of MIS416, including effects on serum cytokine levels and peripheral blood mononuclear cell (PBMC) composition, cytokine/chemokine expression and function.
1. To document any changes in MS clinical status occurring during the 12-week MIS416 dosing period in the dose-confirmation phase, as determined by the Multiple Sclerosis Functional Composite (MSFC), Fatigue Severity Scale (FSS), SF-36, and Expanded Disability Status Scale (EDSS); the frequency of clinical relapses; and signs of clinical activity on serial cranial MRI scans; and
2. To evaluate, in exploratory fashion, any correlations between clinical, radiological and PD outcomes.
A Summary of the study protocol can be viewed at: