- Company's TPM Drug Delivery Technology Demonstrates Substantial Increase
in Lidocaine Penetration Compared to a Leading Marketed Product -
MELBOURNE, Australia, April 30 /PRNewswire-FirstCall/ -- Phosphagenics Limited ("Phosphagenics") (ASX: POH, AIM: PSG, OTCQX: PPGNY) today announced positive results of a pre-clinical study using TPM, the Company's patented drug deliver system, for the targeted delivery of lidocaine, demonstrating increased efficacy while restricting systemic exposure. A phase 1 human clinical trial is scheduled to commence in the third quarter of 2008.
The study was designed to demonstrate the ability of TPM to deliver lidocaine (5%) to a targeted local site after a single topical application, while restricting systemic exposure. Lidocaine concentrations were measured in the skin at the site of application, as well as in the underlying muscle and tissue. The studies were performed in parallel using a leading commercial form of lidocaine, Xylocaine(R) 5%, to assess the relative efficacy of the TPM/Lidocaine formulation.
TPM/Lidocaine or Xylocaine(R) (20 microlitres) were applied to a 2x2 cm2 area of shaved skin on the thigh of the treatment, or control animals (n=10). Blood samples were taken at 0 (before application), 1, 2, 3, and 5 hours after application. Lidocaine concentrations were measured in the skin at the site of application, as well as in the underlying muscle to determine the amount of lidocaine delivered to the local area of application. Plasma lidocaine concentration was quantified to evaluate systemic exposure.
Phosphagenics' TPM/Lidocaine increased, by a statistically significant
margin (p is less than or equal to 0.001), the amount of lidocaine
delivered to the skin at the site of application as compared to
Xylocaine(R) 5%. The lidocaine concentration in skin was approximately 900%
higher 5 hours after topical application of TPM/Lidocaine, compared t
|SOURCE Phosphagenics Limited|
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