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
"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