Clinical Trial Program - MIS416

Latest Trial Annoucement

Phase 2A trial in Progressive Multiple Sclerosis

In October 2010, Innate Immunotherapeutics initiated a Phase 2A trial of its lead drug candidate MIS416 in patients with the progressive forms of Multiple Sclerosis (MS). The study is being conducted at Primorus Clinical Trials, Christchurch, New Zealand, and is programmed for completion in the first quarter of 2012.

The design of the study is summarized as follows:

Study Title:

Primary objectives:

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.

Secondary objctives:

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.

The trial will accrue highly relevant data to guide a subsequent Phase 2B efficacy dosing study programmed to commence in late 2012.

A Summary of the study protocol can be viewed at:

For further details including eligibility critera, please
contact Primorus
Clinical Trials.