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
SOURCE Phosphagenics Limited