Founded in 1998, Altea Therapeutics is developing its PassPort(tm) transdermal drug delivery system to deliver proteins and peptides, small-molecule drugs, genes and vaccines from a skin patch, eliminating the need for invasive needle injection. This breakthrough technology, currently undergoing Phase 1 clinical trials for transdermal delivery of insulin and hydromorphone, revolutionizes the way in which medicines can be administered, increasing efficacy, safety, and compliance. Previous studies have demonstrated that a wide range of pharmaceutical compounds can be delivered through microporated skin, including small molecules (hydromorphone, morphine, lidocaine), peptides (parathyroid hormone, insulin), proteins (interferon alpha, erythropoietin), and even adenoviral vectors. Preliminary data has also shown that proteins (bovine serum albumin) delivered by thermal microporation can generate robust antibody responses in animal models. Finally, studies with several hundred human subjects to date have shown that the microporation process is essentially without sensation and has few or no adverse side effects. In this SBIR Phase I application, we propose to devise a dramatically miniaturized laboratory embodiment (proof-of-concept) of the Activator component of the PassPort system. This will enable the use of this state-of- the-art technology, by virtue of its miniaturization, outside of a medical office or treatment room. This work will require innovative electrical and medical device engineering to achieve the stated objectives. In vitro testing will then be used to confirm functional equivalency between the existing table top models and the miniaturized model. In Phase II we will further optimize the engineering aspects of the Activator and PassPort(tm) system for (i) manufacturability and (ii) ease-of-use including human-factor engineering
