Pre-Clinical Trial Results
April 30 2008 - 2:04AM
UK Regulatory
RNS Number:4072T
Phosphagenics Limited
30 April 2008
30 April 2008
Company Announcement
Phosphagenics Reports Positive Pre-clinical Results for Targeted Delivery of
Lidocaine
- Company's TPM Drug Delivery Technology Demonstrates Substantial Increase in
Lidocaine Penetration Compared to a Leading Marketed Product -
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.
Study Design
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) (20microgram) 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.
Study Results
Phosphagenics' TPM/Lidocaine increased, by a statistically significant margin
(p
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