MELBOURNE, Australia, Sept. 12 /PRNewswire-FirstCall/ -- Phosphagenics Limited today announced that it has received approval to commence a Phase 2 clinical trial of its proprietary transdermal insulin, TPM/Insulin.
The Phase 2 trial, to commence this month, will be single-blinded, placebo controlled, three way cross-over and randomized in up to 60 patients, with the endpoint of assessing the efficacy of TPM/Insulin in patients with type 1 and type 2 diabetes.
The trial, which will be conducted by CMAX at The Royal Adelaide Hospital under the guidance and supervision of Dr. Sepehr Shakib, Director, Department of Clinical Pharmacology, Royal Adelaide Hospital and Associate Professor William Hsu of the Joslin Diabetes Centre, Harvard Medical School, is expected to be completed in the first half of 2008.
Dr. Esra Ogru, Executive Vice President of Research and Development at Phosphagenics, said: “We are excited to reach this milestone and advance our technology for the transdermal delivery of insulin to Phase 2 trials.
“Our Phase 1b trial, conducted by CMAX at the Royal Adelaide Hospital, showed that our TPM/Insulin formulation safely penetrated through human skin and delivered insulin into the blood stream over a sustained period of time without adverse reactions.
“Phosphagenics’ aim is to provide a safe and effective transdermal insulin to treat diabetes,” concluded Dr. Ogru.
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 www.phosphagenics.com
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.
Phosphagenics Limited
CONTACT: Harry Rosen, President and CEO, +61-3-9605-5900, or Mary Bennett,Investor Relations Manager, +61-3-9605-5907, both of Phosphagenics Limited;or US, Brian Ritchie of FD, +1-212-850-5683, for Phosphagenics Limited
Web site: http://www.phosphagenics.com/
