Intranasal vaccine begins clinical trials

A Norovirus vaccine utilising Archimedes Pharma's proprietary enabling ChiSys intranasal drug delivery system has begun Phase I clinical trials.

Intranasal vaccines based on ChiSys combine the advantages of simple, convenient, needle-free and painless administration with immunisation through both systemic and mucosal immune responses. LigoCyte's Norovirus vaccine is the first intranasal vaccine to enter humans for this serious condition.

Archimedes has a strategic alliance with LigoCyte for the development of two vaccines, the other being for anthrax, currently in pre-clinical development. Archimedes will receive r&d payments, milestones and royalties through the development, manufacture and commercialisation of the products.

ChiSys technology enhances immune responses through increasing contact time of the vaccine with the nasal membrane. A number of pre-clinical and clinical studies in a range of infectious diseases, including influenza and diphtheria, have already demonstrated that ChiSys vaccines result in a mucosal response and significantly greater systemic immune response than would otherwise be obtained.

ChiSys also has proven applicability outside vaccine development. It is the enabling technology behind a nasally delivered morphine product, Rylomine, which is being developed by Javelin Pharmaceuticals. Rylomine is currently in Phase III clinical trials for moderate-to-severe postoperative orthopaedic pain.

'ChiSys and PecSys not only provide an important revenue stream for Archimedes but also bring the opportunity for us to develop our own products to drive into our established commercial operations in Europe,' said Richard de Souza, Archimedes' ceo. 'Our own lead product, Nasalfent for the treatment of breakthrough cancer pain, uses PecSys to optimise nasal delivery of fentanyl citrate and recently entered Phase III trials in the US.'