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Phosphagenics to commence Phase 2 TPM/Insulin cinical trial |
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12 Sep 2007 |
Phosphagenics Limited today announced that it has received approval to commence a Phase 2 clinical trial of its proprietary transdermal insulin, TPM/Insulin
MELBOURNE, Australia | September 12, 2007 | Phosphagenics Limited (ASX: POH, AIM: PSG, OTCQX: PPGNY) 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 randomised 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,” she said.
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.
About Diabetes
Diabetes is an illness that occurs when the body does not produce or properly use the hormone insulin.
Insulin, which is produced in the pancreas, enables muscles and other tissues to absorb and utilise glucose (a form of sugar) as the body’s energy source.
When individuals have diabetes, either their pancreas does not produce the insulin they need or their body cannot use its own insulin effectively. As a result, people with diabetes do not use enough of the glucose in the food they eat. This leads to the amount of glucose in the blood increasing, a condition referred to as "high blood sugar" or "hyperglycaemia". High levels of glucose in the blood can lead to medical complications.
The International Diabetes Foundation (IDF) estimates that direct and indirect healthcare costs associated with diabetes exceed $US153 billion globally. IDF believes that some costs are preventable through disease control and management that decreases the longer term costs of complications, such as blindness and vision impairment, cardiovascular disease and kidney failure. At present there is no cure for diabetes.
The world pharmaceutical market for diabetes is estimated to be worth more than $US18 billion per annum and growing.
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.
Phosphagenics’ 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 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. In July 2007, this was upgraded to the International OTCQX, a new premium market tier in the U.S. for international exchange-listed companies, operated by Pink Sheets, LLC.
SOURCE: Phosphagenics Limited |
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