Phosphagenics Announces Positive Preclinical Trial Results for its Transdermal Insulin Formulation

May 25, 2006, 01:00 ET from Phosphagenics Limited

    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
 principal investigator.
     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
 2 diabetes."
     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).
     About Diabetes
     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

SOURCE Phosphagenics Limited