Phosphagenics Initiates its Phase 2 Clinical Trial in Type 1 Diabetes

Mar 19, 2008, 01:00 ET from Phosphagenics Limited

    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
 Phosphagenics. "The Australian clinical trials conducted to date have
 demonstrated that our TPM/Insulin formulation can safely penetrate through
 human skin and deliver insulin into the blood stream over a sustained
 period of time without any adverse events."
     "We will continue to gather additional data and treat Type 2 patients
 at The Royal Adelaide Hospital under the guidance and supervision of Dr.
 Sepehr Shakib, Director, Department of Clinical Pharmacology, Royal
 Adelaide Hospital," continued 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.
     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.
     For more information, please visit Phosphagenics' web site at
     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