Phosphagenics Limited ("Phosphagenics") announced today that it has initiated a phase 1 human clinical trial using its patented drug delivery system, TPM, for the targeted delivery of a leading non steroidal anti-inflammatory drug (NSAID), diclofenac.
The trial will compare the bioavailability and penetration of the topically applied Voltaren(R) gel (1% diclofenac), one of the leading marketed products, and Phosphagenics' diclofenac (at 1% and 2% diclofenac concentrations).
Conducted at the Centre for Pharmaceutical Research, University of South Australia, the Principal Investigator is Professor Allan Evans. The trial is an open label, single centre bioavailability and penetration trial of dermal and systemic pharmacokinetics in 12 healthy adult volunteers, incorporating secondary endpoints of safety and tolerability. The Company expects to obtain and announce the results of this phase 1 trial in the first quarter of 2009.
Dr Esra Ogru, Executive Vice President of Research and Development at Phosphagenics, said; "Diclofenac is a well known topical anti-inflammatory drug most commonly used for sprains and strains. In our preclinical studies with TPM/diclofenac we have demonstrated significant increases in skin penetration of diclofenac compared to the market leader (Voltaren(R)); results we are confident we can replicate in human testing."