Intravenous immunoglobin could offer prevention against Alzheimer’s: Octapharma

Intravenous immunoglobin octagam could open up a new treatment modality to prevent several diseases related to primary immune deficiency including Alzheimers’ disease, according to Octapharma.

Octapharma AG has started the first of a series of Phase III studies for its new 10% high purity intravenous immunoglobulin (IVIG).

The study will investigate the efficacy and safety of this novel immunoglobulin in the treatment of primary immune deficiency.

octagam, Octapharma’s current leading IVIG (an immune globulin human solution for intravenous administration) is registered in about 60 countries, including the EU and the US.

The Phase III study in primary immune deficiency represents the start of a series of planned studies to investigate Octapharma’s new 10% IVIG for a range of neurologic and haematological conditions including idiopathic thrombocytopenic purpura (ITP), Guillain-Barré(C) syndrome (GBS) and Kawasaki disease and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

“Octapharma’s new 10% IVIG will be a step forward in the evolution of IVIG products. In the development of the product, Octapharma has looked to optimise the characteristics of the product for improved patient outcomes, such as high tolerability even at high infusion rates,” stated the coordinating investigator of the study, Professor Michael Borte of Leipzig, Germany.

Pre-clinical studies and initial clinical experiences have confirmed that a favourable tolerability profile may be expected from intravenous immunoglobulin (IVIG), he added.

IVIg suppresses natural killer cells (NK cells) that that may play an important role in several autoimmune diseases.

Whole blood was analyzed before and after IVIg therapy of patients: following IVIg treatment the number of natural killer cells in peripheral blood dropped significantly.

Intravenous immunoglobulin (IVIG) has also been investigated for Alzheimer’s disease (AD).

In the current hypothesis on the pathogenesis of AD, the deposition of  amyloid-beta-peptide plaques in the brain is considered to be related with the development and progression of the disease.

Several animal and small clinical studies have provided evidence that infusions of intravenous immunoglobulin (IVIG) such as octagam decreased the level of the amyloid-beta-peptide level in the cerebrospinal fluid and provided beneficial effects on the cognitive function, thus supporting amyloid clearance theories, Octapharma stated in a press release.

Analysis of studies over a 4-year period found that previous treatment with IVIG was associated with a 42% lower risk of developing Alzheimer’s disease and related disorders, if compared to control subjects that were not treated with IVIG.

Moreover, a recent study by a Swedish research group while performing a nationwide survey on satisfaction with intravenous IgG therapy retrospectively analysed the data of 237 PID patients of above 65 years that have regularly been treated with IVIG due to their immune deficiency.

Based on the general prevalence of Alzheimer’s disease  in Sweden, it could be expected to find 13 patients with AD in this specific population. However, interestingly, none of the 237 patients suffered from Alzheimer’s Disease, the researchers found.

octagam is a 5% (50 mg/mL) immune globulin (human) solution for intravenous administration (IVIG) which is currently registered in about 60 countries, including the U.S.A. and the EU.

In the U.S.A. it is indicated for treatment of primary humoral immunodeficiency (PI), such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiencies.

The Octapharma Group is an independent, Swiss-based biopharmaceutical company. Octapharma  owns five modern, state-of-the-art production facilities in Austria, France, Germany, Sweden and Mexico, respectively.