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news.Australia-based biotechnology company Phosphagenics has initiated a Phase I human clinical trial using its patented drug delivery system, TPM, for the targeted delivery of a pain relief drug, lidocaine.
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The trial will compare the dermal bioavailability and will measure the systemic exposure of lidocaine in one of the leading marketed products, Xylocaine (5% lidocaine), and Phosphagenics’s lidocaine (5% lidocaine).
This trial is being conducted at the Centre for Pharmaceutical Research, University of South Australia, under the guidance of David Foster, as the principal investigator.
It is an open label, single centre bioavailability trial of dermal and systemic pharmacokinetics in 12 healthy adult volunteers incorporating secondary endpoints of safety and tolerability. The company expects to report results of the Phase I trial in the first quarter of 2009.
Esra Ogru, executive vice president of R&D at Phosphagenics, said: “Our preclinical study showed that Phosphagenics’s lidocaine formulation has the potential to provide patients with rapid pain relief, while not increasing systemic exposure, and we are excited to continue moving this program forward efficiently.”