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Phosphagenics' transdermal delivery of insulin in animals: summary of the study
Phosphagenics Limited has received requests for further information following the 20 September 2005 announcement of its potentially groundbreaking achievement in delivering insulin through animal skin using its non-invasive and patient-friendly transdermal delivery system TPM-01.
Insulin is a naturally occurring hormone that reduces the level of glucose in the blood. An animal trial was conducted to determine if insulin, when formulated with Phosphagenics’ patented transdermal drug delivery system TPM-01 and applied on the skin, reduces blood glucose concentration.
The trial, an adaptation of the standard glucose tolerance test, was designed and conducted at Monash University in Melbourne. The trial was completed on 16 September, with analysis of results completed on 19 September 2005. It consisted of 30 rats divided into two treatment groups – insulin and control. Baseline blood glucose concentrations were established for all animals before treatment was applied. Insulin animals (n = 15) received TPM-01 insulin formulation on the skin. A fast-acting monomeric insulin derivative was used. Control animals (n = 15) received a TPM-01 formulation without insulin on the skin.
Thirty minutes after treatment, all animals received a standard glucose load. In all animals, blood glucose concentration was recorded for up to three hours after glucose loading to determine average blood glucose concentrations in insulin and control groups.
The average total blood glucose in the insulin-treated animals was 303 mM.minute (standard error 21.8) compared to the average total blood glucose in the control-treated animals of 401 mM.minute (standard error 14.8). This difference in total blood glucose between insulin- and control-treated animals was highly statistically significant (p < 0.001).
It was concluded that insulin applied on the skin, in formulation with Phosphagenics’ patented transdermal drug delivery system TPM-01, was effective at reducing blood glucose concentrations.
Further preclinical studies are being planned, with the aim of commencing clinical trials in early 2006.
The insulin study provides further evidence of the broad applicability of the TPM-01 transdermal delivery system. As announced in April 2005, TPM-01 successfully delivered morphine in a human Phase I trial, and animal studies have demonstrated that the delivery system can deliver both small molecule drugs such as estradiol, testosterone and atropine and larger peptide drugs such as parathyroid hormone.
For further information, please contact Mr Harry Rosen, Phosphagenics Limited on +61 3 9605 5900 or 0421 322 757.
About Phosphagenics Limited
Phosphagenics is a pharmaceutical and nutraceutical company with a diversified portfolio of patented and proprietary technologies.
Phosphagenics is based in Melbourne, Australia. Its shares are listed on the Australian Stock Exchange (POH) and the London Stock Exchange's Alternative Investment Market (PSG).
Further information regarding Phosphagenics can be found at www.phosphagenics.com.
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