Phosphagenics Initiates its Phase 2 Clinical Trial in Type ...( MELBOURNE Australia March 19 /- P...),Health

MELBOURNE, Australia, March 19 /PRNewswire-FirstCall/ -- Phosphagenics Limited (ASX: POH, AIM: PSG, OTCQX: PPGNY) today announced that it has received ethics approval to commence treating patients with Type 1 diabetes in a Phase 2 clinical trial using its patented transdermal insulin delivery system, TPM/Insulin. The lead clinical investigators of the trial will be Dr. Michael D' Emden, Department of Endocrinology, Royal Brisbane and Women's Hospital, and William Hsu, who is an Assistant Investigator in the Section on Clinical Research at the Joslin Diabetes Centre and an Assistant Professor of Medicine at Harvard Medical School, Boston, MA.

Ethics approval was granted on the basis of data generated from previous trials and the first arm of the Phase 2 trial, which involves the treatment of patients with Type 2 diabetes. Phosphagenics had to demonstrate safety and the effective delivery of insulin into the bloodstream of patients with Type 2 diabetes prior to receiving ethics approval to commence a trial for patients with Type 1 diabetes.

The Phase 2 trial in Type 1 patients is due to commence next month and will be conducted at QPharm in Queensland, Australia. QPharm is a well- established clinical facility and uniquely placed to conduct this type of diabetes trial. The trial is a randomized, single-blinded trial which aims to assess the efficacy of TPM/Insulin. The results of this trial will be used to assist in obtaining an IND from the FDA. This will enable Phosphagenics to commence the next phase of its clinical development program for TPM/Insulin at the Joslin Diabetes Centre. It is anticipated that the U.S. portion of the study will start this year.

"We have gathered the appropriate positive data to progress our Phase 2 study to the treatment of patients with Type 1 diabetes, which is the ideal patient population to prove the efficacy of our TPM/Insulin," said Dr. Esra Ogru, Executive Vice President of Research and Development at P
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