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
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. Ogru.
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 http://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.
|SOURCE Phosphagenics Limited|
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