Initiation of Phase 1 Clinical Trial

    RNS Number : 0476E
  Phosphagenics Limited
  23 September 2008
   



    Company Announcement


    Phosphagenics Announces Initiation of Phase 1 Clinical Trial in Humans for its Transdermal Lidocaine

    Phosphagenics Limited ("Phosphagenics") (ASX: POH; AIM: PSG; OTCQX: PPGNY) announced today that it has initiated a phase 1 human
clinical trial using its patented drug delivery system, TPM, for the targeted delivery of a leading pain relief drug, lidocaine. The trial
will compare the dermal bioavailability and will measure the systemic exposure of lidocaine in one of the leading marketed products,
Xylocaine® (5% lidocaine), and Phosphagenics' lidocaine (5% lidocaine).

    Earlier this year, the Company's pre-clinical results demonstrated that through the utilisation of Phosphagenics' patented lidocaine
formulation, skin concentration of lidocaine was approximately 900% higher 5 hours after topical application as compared to Xylocaine®. In
addition, Phosphagenics' lidocaine was able to significantly increase the depth of lidocaine penetration by approximately 500% in the thigh
muscle of animals treated compared to Xylocaine®. 

    Dr Esra Ogru, Executive Vice President of Research and Development at Phosphagenics, said; "Lidocaine is a well known topical
anaesthetic used for a wide variety of ailments, including temporary relief of rashes, stings, sprains, strains, bites, and burns. However
it has poor penetration into the dermis, frequently rendering it largely ineffective."

    "Our pre-clinical study showed that Phosphagenics' lidocaine formulation has the potential to provide patients with rapid pain relief,
while not increasing systemic exposure, and we are excited to continue moving this program forward efficiently," she said.

    This most recent trial is being conducted at the Centre for Pharmaceutical Research, University of South Australia, under the guidance
of Dr. David Foster, as the Principal Investigator. It is an open label, single centre bioavailability trial of dermal and systemic
pharmacokinetics in 12 healthy adult volunteers incorporating secondary endpoints of safety and tolerability. The Company expects to report
results of the phase 1 trial in the first quarter of 2009.  

    Harry Rosen, President and CEO at Phosphagenics said; "We believe we have a very attractive commercial product that has shown the
potential to substantially enhance the current standard of care."


    Ends*

    APPENDIX AND NOTES TO EDITORS


    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                                             FD
 Executive VP R&D                                     [phone]
 [phone]

 Mary McSwiggan
 Phosphagenics Limited
 Investor Relations Manager
 [phone]

 Hugh Field
 Collins Stewart Europe Limited
 (Nomad)
 [phone]


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