Phosphagenics to Commence Phase 1b Transdermal Insulin Clinical Trial in Second Quarter

May 03, 2007, 01:00 ET from Phosphagenics Limited

    MELBOURNE, Australia, May 3 /PRNewswire-FirstCall/ -- Phosphagenics
 Limited (ASX: POH) (AIM: PSG) (ADR/OTC: PPGNY) announced today that the
 Company intends to initiate a Phase 1b clinical trial to demonstrate the
 efficacy and safety of the improved formulation of its transdermal insulin
 product, TPM-02/Insulin, containing long-acting insulin. The trial is
 expected to commence in the second quarter of 2007.
     TPM-02/Insulin gel is being developed as a novel "needle-free" way of
 administering insulin to patients with diabetes. Following the successful
 completion of a Phase 1a study utilizing short-acting insulin, this trial
 will assess an optimized formulation of long-acting insulin. Recent
 advancements in Phosphagenics' patented TPM-02 delivery system have enabled
 the formulation of long-acting insulin; which is significantly less
 expensive than short- acting insulin, provides appropriate levels of
 insulin in humans and is commercially attractive.
     "In August of 2006, our Phase 1a study demonstrated that a single
 application of TPM-02/Insulin gel rapidly delivered insulin across the skin
 and into the bloodstream without any adverse reactions," said Dr. Esra
 Ogru, Executive Vice President at Phosphagenics. "Additionally, it
 significantly lowered blood glucose, insulin and c-peptide levels."
     "The Phase 1b study is intended to provide additional supporting data
 for an Investigational New Drug application to the U.S. Food and Drug
 Administration," continued Dr. Ogru. "The trial will be conducted by CMAX
 at the Royal Adelaide Hospital, South Australia, will include up to 45
 healthy volunteers and is expected to lead directly into the start of a
 large multi- site Phase 2 trial that is likely to include up to several
 hundred patients."
     "This is an important step for the development and commercialization of
 TPM-02/Insulin," said Harry Rosen, President and CEO of Phosphagenics.
 "This technology has the potential to provide diabetics with a non-invasive
 and effective treatment, and we look forward to its continued development."
     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). An ADR - Level 1 program has been established in the US with
 the Bank of New York (PPGNY) for US investors to trade in Phosphagenics'
 stock on the 'over-the-counter' market.
     For more information, please visit Phosphagenics' web site at

SOURCE Phosphagenics Limited