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Phosphagenics initiates Phase 2a clinical trial of its transdermal morphine cream
Melbourne, Australia, 8 May 2006
Phosphagenics Limited ("Phosphagenics"), the Australian Stock Exchange (ASX:POH) and the London Stock Exchange’s Alternative Investment Market (AIM:PSG) listed pharmaceutical and nutraceutical company, today announces commencement of a Phase 2a clinical trial of its transdermal morphine cream, TPM-01/Morphine. The Phase 2a trial, investigating the efficacy, absorption and metabolism of morphine administered using Phosphagenics’ novel transdermal carrier TPM-01, will be conducted at the Royal Adelaide Hospital, South Australia. Preliminary results are expected during the third quarter of 2006.
In the trials, doses of morphine will be examined in 48 healthy male volunteers aged between 18 and 49 years. Volunteers will be randomly assigned into a dose group and either receive active treatment or placebo treatment in a double blinded manner. The efficacy of Phosphagenics transdermal morphine in producing the well recognised effects of morphine in humans, such as changes in pupil size and decreased response to painful stimuli, will be measured.
Dr Esra Ogru, Executive Director of Research and Development at Phosphagenics, said: "The initiation of phase 2a clinical trials of morphine with our proprietary transdermal delivery technology is a significant milestone in the development or our pain management product. It will also provide further clinical proof of the efficacy of Phosphagenics’ transdermal delivery technology."
About Phosphagenics’ Transdermal Morphine
Phosphagenics’ transdermal morphine (TPM-01/Morphine) is a non-invasive, patient friendly gel or cream that delivers morphine through the skin into the bloodstream. Previous clinical trials of TPM-01/Morphine have achieved 48 hours of therapeutic morphine blood levels from a single dose, which compares favourably to the longest acting morphine products available which provide only up to 24 hours of therapeutic blood levels per dose.
Phosphagenics expects that a transdermal product capable of providing therapeutic blood levels of morphine for 48 hours or longer would fill an unmet clinical need for chronic pain patients (by minimising the occurrence of "breakthrough pain") and provide cost-effective treatment solutions for hospice patients, especially those unable to swallow oral preparations of morphine. There is currently no commercially available transdermal morphine product.
About Phosphagenics’ Transdermal Carrier Technology
Phosphagenics patented transdermal technology is a carrier that utilises existing natural transport mechanisms to "carry" drugs across the skin without disrupting the surface of the skin. In contrast, alternative transdermal technologies either: rely on passive diffusion across skin membranes improving drug penetration with solvents, enhancers or lasers that modify the properties of the outermost layers of the skin; or, use electrical or thermal technologies to "push" drugs through the skin.
Both formulations of the carrier (TPM-01 and TPM-02) have anti-inflammatory and anti-erythema properties which minimise skin irritation, can provide sustained transdermal delivery of drugs and can deliver a range of drugs through the skin. TPM-01 delivers small molecule drugs (e.g. morphine, fentanyl, oxycodone, atropine, estradiol, testosterone) and TPM-02 delivers both small and large molecule drugs (e.g. insulin, PTH, proteins).
About Phosphagenics Limited
Phosphagenics is a pharmaceutical and nutraceutical company with a diversified portfolio of technologies encompassing drug delivery, drug enhancement, and active ingredients for the nutraceutical industry (dietary supplements, functional foods and personal care products).
Phosphagenics is based in Melbourne, Australia. Its shares are listed on the Australian Stock Exchange (POH) and the London Stock Exchange's Alternative Investment Market (PSG). An American Depository Receipts-Level 1 facility has been established in the US with the Bank of New York (PPGNY) for the trading of the Company’s shares in the US ‘Over the Counter’ market. Further information regarding Phosphagenics can be found at www.phosphagenics.com.
For further information please contact:
Phosphagenics Limited:
Dr Esra Ogru, Executive Director Research & Development
Telephone: +61 3 9605 5900 or 0402 080 846
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