Aegis’ ProTek(R) Excipients Prevent Aggregation and Eliminate Unwanted beta-Interferon Immunogenicity

SAN DIEGO, CA–(Marketwire – September 1, 2010) –  Recombinant human beta-interferon reduces the frequency of multiple sclerosis (MS) exacerbations and improves MS outcome measures. Unfortunately, current beta-interferon drug products form aggregates that provoke a neutralizing antibody response in MS patients, significantly reducing the effectiveness of the drug.

In a Journal article titled: “n-Dodecyl-?-D-Maltoside Inhibits Aggregation of Human Interferon-?-1b and Reduces Its Immunogenicity” which appeared in the Journal of Neuroimmune Pharmacology, published online on June 7, 2010 scientists from a leading US University Medical School report that addition of a patented ProTek® excipient, a pharmaceutical grade of dodecyl maltoside developed by Aegis, inhibits aggregation and prevents development of antibodies in vivo suggesting a route to greatly improved beta interferon formulations. The abstract of the scientific report may be viewed online at: http://www.springerlink.com/content/v46614510n311211/.

According to Dr. Edward T. Maggio, CEO of Aegis Therapeutics, “Aggregation-induced immunogenicity is a problem for many protein therapeutics, reducing drug effectiveness and in extreme instances, causing life-threatening adverse reactions as with erythropoietin and Factor VIII. And because protein aggregation also adversely affects manufacturing process yields and drug potency it has become a major concern for pharmaceutical formulators worldwide.”

ProTek® excipients are being used to prevent aggregation of monoclonal antibodies, human growth hormone, parathyroid hormone, and insulin, as well as a number of undisclosed proprietary peptide or protein therapeutics now in development.

About Aegis Therapeutics
Aegis Therapeutics commercializes its patented drug delivery and drug formulation technologies through product specific licenses. Our Intravail® technology enables the non-invasive delivery of a broad range of protein, peptide and non-peptide macromolecular therapeutics that can currently only be administered by injection with exceptionally high and unmatched bioavailability. Our ProTek® technology provides proprietary, easily manufacturable, aqueous dosage forms that are stable at elevated temperature and that reduce unwanted immunogenicity of many protein and peptide therapeutics.