SAN DIEGO, CA--(Marketwired - Jul 8, 2014) - Aegis Therapeutics LLC announced today that it has been awarded its U.S. Patent No. 8,772,231 providing dramatically stabilized insulin formulations suitable for metered nasal spray delivery or injection based upon Aegis' patented Intravail® transmucosal absorption enhancer and ProTek® protein stabilization technologies.
While current insulin formulations denature in less than four hours under stressed condition such as elevated room temperatures or shaking, the Aegis ProTek® formulation provides stability for at least 90 days under continuous agitation conditions at 37 degrees C (body temperature). A proof of concept study using the gold standard "glucose clamp method" for assessing performance of insulin formulations showed that Aegis' stabilized form of insulin can be administered via a metered nasal spray with excellent bioavailability.
Nasal insulin administration, unlike pulmonary administration, avoids any risk of lung exposure to insulin since the droplet size of nasally administered drugs physically confines deposition to the anterior portion of the nasal passage. According to the FDA Black Box Warning, clinical studies with the pulmonary insulin Exubera® showed a four-fold increase in the incidence of lung cancer among patients with a history of smoking.
Ability to carry around the insulin formulation at body temperature for extended periods of time coupled with elimination of injections allows for a convenient means of insulin administration while patients are "on the go" or where refrigeration may not be easily or reliably accessible. Aegis is seeking licensees for its "shirt pocket" insulin in Asia, North America, the EU and the Middle East.
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About Aegis Therapeutics
Aegis Therapeutics LLC commercializes its patented drug formulation technologies through product-specific licenses. Intravail® drug delivery technology enables non-invasive delivery of a broad range of protein, peptide and non-peptide drugs that can currently only be administered by injection, via the oral, buccal, and intranasal administration routes, and with high bioavailability. Our ProTek® excipients stabilize, prevent aggregation, and reduce unwanted immunogenicity of protein and peptide therapeutics while avoiding oxidative damage caused by polysorbate surfactants.
For more information about Aegis, please visit: http://www.aegisthera.com.
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