MELBOURNE, Australia, May 3 /PRNewswire-FirstCall/ -- Phosphagenics Limited (AIM: PSG) 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 http://www.phosphagenics.com
Phosphagenics Limited
CONTACT: Company - Dr. Esra Ogru, Executive Vice President Research &Development, Phosphagenics Limited, +61-3-9605-5900, or Mr. Harry Rosen,President and CEO, Phosphagenics Limited, +61-3-9605-5900; or U.S. Investorand Media - Brian Ritchie or Evan Smith, both of FD, +1-212-850-5600
Web site: http://www.phosphagenics.com/
