Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results

Company's TPM-02/Insulin Significantly Lowered Blood Glucose without

Producing Any Adverse Reactions

Phase 2 Trial Expected to Begin upon Ethics Approval with Results due in Q1


Aug 08, 2007, 01:00 ET from Phosphagenics Limited

    MELBOURNE, Australia, Aug. 8 /PRNewswire-FirstCall/ -- Phosphagenics
 Limited ("Phosphagenics") (ASX: POH, AIM: PSG, OTCQX: PPGNY) today
 announced the successful completion of a Phase 1b transdermal insulin
 trial. The positive results of the trial demonstrated the ability of the
 Company's TPM technology to deliver insulin into the bloodstream in a
 non-invasive manner without causing any adverse events. Phosphagenics'
 TPM-02/Insulin formulation is being developed as a novel "needle-free" way
 of administering insulin to patients with diabetes.
     The Phase 1b clinical trial, conducted at the Royal Adelaide Hospital
 in South Australia by CMAX, an independent clinical research organization,
 assessed the efficacy and safety of two TPM/Insulin formulations in 45
 volunteers. Blood glucose, endogenous insulin and C-peptide levels were
 measured to assess efficacy.
     Dr. Esra Ogru, Executive Vice President of Research and Development at
 Phosphagenics, said: "The Phase 1b trial showed that our TPM/Insulin
 formulation safely penetrated through the human skin and delivered insulin
 into the bloodstream over a sustained period of time, without causing
 adverse reactions."
     "We believe that these results are indicative of Phosphagenics'
 potential to provide the millions of insulin-dependent diabetics with a
 non-intrusive alternative to multiple needle injections each day," said Dr.
     Phosphagenics intends to continue clinical development of its
 transdermal insulin. Preparations are underway for a Phase 2 trial to be
 conducted by CMAX at the Royal Adelaide Hospital under the guidance and
 supervision of Associate Professor William Hsu of the Joslin Diabetes
 Centre (Harvard Medical School) and Dr. Sepehr Shakib (Director, Department
 of Clinical Pharmacology, Royal Adelaide Hospital).
     An application for the commencement of a Phase 2 trial has been
 submitted for ethics approval. The trial will commence as soon as possible
 following ethics approval. The Phase 2 study will be a single-blinded,
 placebo controlled, randomized trial that will assess the pharmacodynamics
 and pharmacokinetics of transdermally delivered insulin using TPM
 technology in diabetic patients. The trial is expected to be completed by
 the end of the first quarter, 2008
     Phosphagenics is also currently in the process of compiling an
 Investigational New Drug package that would allow the Company to continue
 its Phase 2 clinical trial program in the U.S. after completion of the
 Australian trials.
     About Phosphagenics Limited
     Phosphagenics is a Melbourne-based, globally driven biotechnology
 company focused on the discovery of new and cost effective ways to enhance
 the bioavailability, activity, safety and delivery of proven pharmaceutical
 and nutraceutical products. The Company's core technology is built around
 the science and application of phosphorylation, a process where the
 addition of a phosphate group has been found to enhance the
 bioavailability, activity and safety of existing pharmaceuticals and
 nutraceuticals, as well as to assist in the production of drug delivery
 platforms. Phosphagenics' shares are listed on the Australian Stock
 Exchange (POH) and the London Stock Exchange's Alternative Investment
 Market (PSG). In March 2006, an ADR - Level 1 program was established in
 the U.S. with The Bank of New York Mellon (PPGNY) for U.S. investors to
 trade in Phosphagenics' stock on the 'over-the-counter' market. This has
 now been upgraded to the International OTCQX, a new premium market tier in
 the US for international exchange-listed companies, operated by Pink
 Sheets, LLC.
     For more information and to view the clinical trial results in full,
 please visit Phosphagenics' web site at
     About Phosphagenics' Transdermal Carrier Technology
     Phosphagenics' patented transdermal carrier technology (TPM) utilises
 natural dermal transport mechanisms to rapidly transport small and large
 molecules across the skin without disrupting or damaging its surface.
     The Company believes that the key advantages of this delivery system
 includes the fact that it possesses anti-inflammatory and anti-erythema
 properties, thus minimising skin irritation, and has the ability to provide
 a sustained systemic delivery of a wide range of drugs - ranging from
 relatively small molecules (e.g. morphine, fentanyl, oxycodone, atropine,
 estradiol, testosterone) to large molecules (e.g. insulin and PTH) - from a
 single application. Additionally, the TPM delivery technology can be cost-
 effectively manufactured in a wide range of presentations (e.g. gel, paste,
 liquid and powder) adding value to existing pharmaceuticals.
     Safe Harbor Statement
     This press release contains forward-looking statements based on current
 expectations of future events. If underlying assumptions prove inaccurate
 or unknown risks or uncertainties materialise, actual results could vary
 materially from the Phosphagenics' expectations and projections. Risks and
 uncertainties include general industry conditions and competition; economic
 conditions, such as interest rate and currency exchange rate fluctuations;
 technological advances and patents attained by competitors; challenges
 inherent in new product development, including obtaining regulatory
 approvals; domestic and foreign health care reforms and governmental laws
 and regulations.

SOURCE Phosphagenics Limited