MELBOURNE, Australia, Sept. 12 /PRNewswire-FirstCall/ -- 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 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
|SOURCE Phosphagenics Limited|
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