Archimedes Pharma Announces Successful Proof-of-Concept Results on Two Intranasal Developmen...(ited which also developed PecSys(TM) the...),Health

Dr Alan Smith, VP Research & Development, at Archimedes, commented: "These results illustrate the expertise at Archimedes in taking well characterized therapeutic compounds such as apomorphine and diazepam and creating innovative, tangible products with clear potential advantages over currently marketed agents. We look forward to taking these exciting therapeutics into further trials."

Archimedes will now begin preparations to take both IN Apomorphine and IN Diazepam into further clinical trials and management anticipates the initiation of Phase II studies later in 2009. If development proceeds to plan, both IN Apomorphine and IN Diazepam could be approved in 2012.

IN Apomorphine - trial design, results and development rationale

The pharmacokinetics (PK) and safety/tolerability of Archimedes' IN Apomorphine formulation (3.5 mg dose), compared with a commercial subcutaneous (SC) injection (2 mg dose), were demonstrated in a Phase I proof of principle study in 12 healthy volunteers. IN Apomorphine was well and reproducibly absorbed via the nasal route with therapeutically relevant plasma concentrations reached within 10 minutes of administration. The product showed good nasal tolerability and systemic adverse effects were comparable to those after SC injection and typical of adverse effects that commonly occur in apomorphine naïve individuals. The significant and reproducible plasma levels with IN Apomorphine are consistent with a potential for rapid treatment of hypomobility in advanced Parkinson's disease (PD) and illustrate the product's potential to replace apomorphine injections.

Apomorphine, a potent dopamine agonist, is currently the only drug approved specifically for the treatment of acute motor fluctuations/hypomobility (freezing or "off" episodes) in patients with advanc
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