Therapeutics

Gamunex

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Overview

Name: Gamunex
Synonyms: Intravenous Immunoglobulin, Human Albumin Combined With Flebogamma
Therapy Type: Immunotherapy (passive) (timeline)
Target Type: Amyloid-Related (timeline), Inflammation (timeline)
Condition(s): Alzheimer's Disease
U.S. FDA Status: Alzheimer's Disease (Phase 2/3)
Company: Grifols Biologicals Inc.
Approved for: Immunodeficiency, chronic inflammatory demyelinating neuropathy

Background

This immunoglobulin preparation is used in obstetric indications to prevent and treat blood conditions related to rhesus factor incompatibility. It is one of several IVIg products being tested clinically as an Alzheimer's treatment following Phase 1 and 2 results for Baxter Healthcare's IVIg product, Gammagard™.

Findings

A multicenter Phase 2/3 trial being conducted in Spain is comparing three doses of 5 percent human albumin plus 5 percent immunoglobulin to placebo delivered intravenously in 350 people with mild to moderate Alzheimer's disease. The primary outcome is change on the ADAS-Cog after 14 months of treatment. See clinicaltrials.gov

Clinical Trial Timeline

  • Phase 2/3
  • Study completed / Planned end date
  • Planned end date unavailable
  • Study aborted
Sponsor Clinical Trial 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
Grifols Biologicals Inc. NCT01561053
N=350

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References

Therapeutics Citations

  1. Gammagard™

External Citations

  1. clinicaltrials.gov

Further Reading