Aegis Therapeutics Announces Successful Human Clinical Study Results for Intravail(R).

SAN DIEGO -- Aegis Therapeutics today announced the completion of its first human clinical study -- a 10-patient, 3-way crossover trial designed to confirm the effectiveness of Intravail(R) absorption enhancement agents in increasing intranasal bioavailability of peptide and protein drugs. The study, using a currently marketed drug of approximately 4,000 Daltons in size, revealed an average systemic bioavailability of approximately 35% for the Intravail(R) formulation compared to an average of 7% for the identical commercial formulation without Intravail(R). Aegis' Intravail(R) provides exceptionally high and unmatched bioavailability performance via the intranasal and other mucosal membrane administration routes.

Dr. Edward Maggio, Aegis' Chief Executive Officer, commented: "This is a great step in confirming the effectiveness of our Intravail(R) technology to deliver peptide drugs into systemic circulation in humans."

"These results quantitatively confirm the unmatched intranasal bioavailability reported previously in primate and non-primate animal studies," said Don Grimm, Aegis' Executive Chairman. "Intravail(R) offers significantly greater bioavailability than recently published results using other current intranasal delivery technologies for similarly sized peptides."

Intravail(R) allows the intranasal delivery of a growing number of peptide or protein drugs used to treat a wide range of human diseases. Examples include insulin, growth hormone, parathyroid hormone, GLP-1, amylin, and interferon, among many others. Unlike dry-powder inhalable systems for pulmonary delivery of peptide drugs to the lungs that require specialized and expensive controlled-particle-size manufacturing technology, Aegis' Intravail(R) intranasal formulations use standard and comparatively inexpensive homogeneous liquid formulation and fill technology and are administrable using simple "off the shelf" metered nasal spray devices.

Aegis licenses its technology on a product-by-product exclusive basis. At present, Aegis has granted exclusive licenses for a total of eight intranasal formulations for peptide, protein, and non-peptide drugs. Companies seeking solutions for efficient transmucosal delivery of peptide or protein drugs, or formulation problems related to loss of biological activity, aggregation, or unwanted immunogenicity, should contact Ralph Barry, Chief Business Officer, for further information.

About Aegis Therapeutics

Aegis Therapeutics LLC is a drug delivery technology company commercializing its patented or proprietary drug delivery and drug formulation technologies through product-specific licenses. Our Intravail(R) drug delivery 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. Aegis' Intravail(R) absorption enhancement agents provide exceptionally high and unmatched bioavailability performance, comparable in efficiency to subcutaneous injection, via the intranasal and other mucosal membrane administration routes. Our ProTek(TM) technology allows creation of proprietary, easily manufacturable, and stable aqueous or lyophilized dosage forms that maintain the integrity and physiological activity of many protein and peptide therapeutics. ProTek(TM) technology is applicable to injectable, intranasal, and other dosage forms of peptide or protein therapeutics.

For more information about Aegis, please visit the Aegis website at: http://www.aegisthera.com.