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Phosphagenics:
Favourable toxicology results support broadening transdermal morphine
(TPM-01/Morphine) clinical program |
Melbourne, Australia, 10 October
2006: Phosphagenics Limited (“Phosphagenics”) (ASX: POH; AIM: PSG) announced
today the successful completion of large-scale chronic toxicology studies on its
patented transdermal morphine formulation, TPM-01/Morphine, and the carrier
platform gel technology, TPM-01. The results of this pre-clinical study will
form part of a US Food and Drug Administration Investigational New Drug data
package for the indication of chronic pain.
In this trial, the TPM-01/Morphine formulation was administered daily for four
weeks, at a human equivalent dose of approximately 298 mg/kg/day or 97mg/kg/day.
In the animals treated with either TPM-01/Morphine or the TPM-01 gel alone, no
treatment-related changes were observed in clinical signs, dermal reactions,
body weight, food intake, haematology, clinical chemistry, urinalysis, organ
weights or macroscopy and histopathology of the organs and tissues.
These favourable results provide supporting safety data for examining repeat
doses of TPM-01/Morphine in humans. Phosphagenics therefore proposes to request
an amendment to the protocol of the Phase IIa study announced in May 2006. The
proposed amendment is to evaluate repeated doses of TPM-01/Morphine in humans,
in contrast to the original protocol which was limited to evaluation of single
dose acute application.
This amendment, upon approval by the responsible Ethics Committee, allows for
the earlier pursuit of Phosphagenics’ goal to develop TPM-01/Morphine for the
management of chronic pain. The chronic pain indication is the larger segment of
the pain market and involves administration of repeated doses of analgesics for
pain management. Phosphagenics anticipates that the clinical results will be
available in early 2007.
ENDS…
About Phosphagenics’ Transdermal Carrier Technology
Phosphagenics’ patented transdermal carrier technology (TPM) utilises natural
dermal transport mechanisms to rapidly transport small and large molecules
across the skin without disrupting or damaging its surface.
The Company believes that the key advantages of this delivery system includes
the fact that it possesses anti-inflammatory and anti-erythema properties, thus
minimising skin irritation, and has the ability to provide a sustained systemic
delivery of a wide range of drugs – ranging from relatively small molecules
(e.g. morphine, fentanyl, oxycodone, atropine, estradiol, testosterone) to large
molecules (e.g. insulin and PTH) – from a single application. Additionally, the
TPM delivery technology can be cost-effectively manufactured in a wide range of
presentations (e.g. gel, paste, liquid and powder) adding value to existing
pharmaceuticals.
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 has been established in the US with the Bank of New York (PPGNY) for US
investors to trade in Phosphagenics’ stock on the ‘over-the-counter’ market.
For more information, please visit Phosphagenics’ web site at
www.phosphagenics.com .
Contact details:
Phosphagenics Ltd
Dr Esra Ogru
Executive Director Research & Development
Ph: +61 3 9605 5900 or M: +61 (0) 402 080 846
Mr Harry Rosen
Phosphagenics Ltd
Managing Director
Ph: +61 3 9605 5900 or M: +61 (0)421 322 757
Northbank Communications
Gemma Bradley / Justine Lamond
Ph: +44 (0)20 3008 7550
g.bradley@northbankcommunications.com
/ j.lamond@northbankcommunications.com
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