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PSG Phosphagen.

2.25
0.00 (0.00%)
24 May 2024 - Closed
Delayed by 15 minutes
Share Name Share Symbol Market Type Share ISIN Share Description
Phosphagen. LSE:PSG London Ordinary Share AU000000POH7 ORD NPV
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.00 0.00% 2.25 0.00 01:00:00
Industry Sector Turnover Profit EPS - Basic PE Ratio Market Cap
0 0 N/A 0

Phase 2 Clinical Trial

19/03/2008 7:00am

UK Regulatory


RNS Number:3365Q
Phosphagenics Limited
19 March 2008

19 March 2008


Company Announcement

               Phosphagenics Initiates its Phase 2 Clinical Trial
                               in Type 1 Diabetes


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 randomised, 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.

ENDS....


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
www.phosphagenics.com

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.


Company Contact Details:                       U.S. Investor and Media Contacts:
Dr. Esra Ogru                                  Brian Ritchie
Phosphagenics Limited                          Financial Dynamics
Executive VP of Research and Development       +1 212 850 5600
+61 3 9605 5900

Mary McSwiggan
Phosphagenics Limited
Investor Relations Manager
+61 3 9605 5907


                      This information is provided by RNS
            The company news service from the London Stock Exchange
END
RESEAEDPFEKPEFE

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