MELBOURNE, Australia, May 25 /PRNewswire-FirstCall/ -- Phosphagenics
Limited (ASX: POH) (AIM: PSG) today announced positive results from the
preclinical trial of its transdermal insulin delivery technology. The
results indicate that Phosphagenics' transdermal carrier, TPM-02,
successfully delivered insulin through the skin of non-diabetic pigs,
significantly reducing blood glucose concentrations. The formulation is
being developed as a novel way to administer insulin to diabetics.
In the study, conducted at Primary Industries Research, Victoria,
Australia, the pigs were fasted overnight and received a continuous
infusion of dextrose (a form of glucose), 30 minutes after applying
TPM-02/insulin to the animals' skin. The concentration of glucose in the
blood was tested at regular time intervals. The group that received
TPM-02/insulin (6 pigs) had significantly lower (p=0.005) blood glucose
levels than the control group (7 pigs), thereby indicating the transdermal
delivery and subsequent activity of insulin.
The independent principal investigator of the study, Professor Frank
Dunshea, Department of Primary Industries, Victoria, said: "The study has
successfully demonstrated the ability of TMP-02/insulin to deliver insulin
across the skin of pigs at levels sufficient to lower glucose in the blood.
These results are impressive, as the non-diabetic pig model is
considered to be robust for both testing the penetration of drugs across
skin as well as for determining the efficacy of diabetes therapies: there
is typically a close likeness between pigs and humans where transdermal
delivery is concerned."
The study was a progression from a similar glucose tolerance study
carried out in rats in September 2005. A human Phase I study in healthy
volunteers will commence in Q3, 2006, with William Hsu MD, clinical
investigator at the Joslin Diabetes Centre of Harvard Medical School as a
Dr Hsu commented: "This is an important result. A topical human insulin
would be a highly advantageous treatment modality for both Type 1 and Type
Notes to Editors
About Phosphagenics' Transdermal Carrier Technology
Phosphagenics patented transdermal technology is a carrier that
utilises existing natural transport mechanisms to "carry" drugs across the
skin without disrupting the surface of the skin. In contrast, alternative
transdermal technologies either: rely on passive diffusion across skin
membranes improving drug penetration with solvents, enhancers or lasers
that modify the properties of the outermost layers of the skin; or, use
electrical or thermal technologies to "push" drugs through the skin.
Both formulations of the carrier (TPM-01 and TPM-02) have
anti-inflammatory and anti-erythema properties which minimise skin
irritation, can provide sustained transdermal delivery of drugs and can
deliver a range of drugs through the skin. TPM-01 delivers small molecule
drugs (e.g. morphine, fentanyl, oxycodone, atropine, estradiol,
testosterone) and TPM-02 delivers both small and large molecule drugs (e.g.
insulin, PTH, proteins).
Diabetes is an illness that occurs as a result of problems with the
production and supply of the hormone insulin.
Digested food is turned into glucose, a form of sugar, which is used as
the body's energy source. Insulin, which is produced in the pancreas,
enables muscles and other tissues to absorb glucose from the bloodstream.
When an individual has diabetes, either the pancreas does not produce
the insulin that is needed or the body cannot use its own insulin
effectively. As a result, people with diabetes do not use enough of the
glucose in the food they eat. This leads to an increase in the amount of
glucose in the blood, a condition referred to as "high blood sugar" or
"hyperglycaemia". High levels of glucose in the blood can lead to medical
The International Diabetes Foundation (IDF) estimates that direct and
indirect healthcare costs associated with diabetes exceed US$153 billion
globally. IDF believes that some costs are preventable through disease
control and management that decreases the longer term costs of
complications, such as blindness and vision impairment, cardiovascular
disease and kidney failure. At present there is no cure for diabetes.
The world market for insulin is estimated to be worth more than US$5.5
billion per annum and growing.
About Phosphagenics Limited
Phosphagenics is a pharmaceutical and nutraceutical company with a
diversified portfolio of technologies encompassing drug delivery, drug
enhancement, and active ingredients for the nutraceutical industry (dietary
supplements, functional foods and personal care products).
Phosphagenics' shares are listed on the Australian Stock Exchange
(ASX:POH) and the Alternative Investment Market of the London Stock
Exchange (AIM:PSG). In March 2006 the Company also announced the initiation
of a Level 1 American Depository Receipt (ADR) programme in the US with The
Bank of New York (PPGNY.PK). This programme will enable the trading of the
Company's shares in the US 'Over the Counter' market. Further information
regarding Phosphagenics can be found at www.phosphagenics.com.
SOURCE Phosphagenics Limited