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Phosphagenics Announces Initiation of Phase 1 Clinical Trial in Humans for Its Transdermal Lidocaine
Date:9/23/2008

MELBOURNE, Australia, Sept. 23 /PRNewswire-FirstCall/ -- Phosphagenics Limited ("Phosphagenics") (ASX: POH; AIM: PSG; OTCQX: PPGNY) 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 pain relief drug, lidocaine. The trial will compare the dermal bioavailability and will measure the systemic exposure of lidocaine in one of the leading marketed products, Xylocaine(R) (5% lidocaine), and Phosphagenics' lidocaine (5% lidocaine).

Earlier this year, the Company's pre-clinical results demonstrated that through the utilisation of Phosphagenics' patented lidocaine formulation, skin concentration of lidocaine was approximately 900% higher 5 hours after topical application as compared to Xylocaine(R). In addition, Phosphagenics' lidocaine was able to significantly increase the depth of lidocaine penetration by approximately 500% in the thigh muscle of animals treated compared to Xylocaine(R).

Dr. Esra Ogru, Executive Vice President of Research and Development at Phosphagenics, said; "Lidocaine is a well known topical anaesthetic used for a wide variety of ailments, including temporary relief of rashes, stings, sprains, strains, bites, and burns. However, it has poor penetration into the dermis, frequently rendering it largely ineffective."

"Our pre-clinical study showed that Phosphagenics' 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," she said.

This most recent trial is being conducted at the Centre for Pharmaceutical Research, University of South Australia, under the guidance of Dr. 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 saf
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