Investors

Thursday, 22 February 2007 11:00

Clinuvel reports first positive Phase II clinical trial results of CUV1647 in new indication - EPP

Clinuvel Pharmaceuticals Limited (ASX:CUV) is pleased to announce that a Phase II trial of CUV1647 met its endpoints in Erythropoietic Protoporphyria (EPP) patients (see Appendix I).

The preliminary results of this photo-provocation trial showed that CUV1647 significantly delayed or abrogated the onset of pain induced by light stimulation. Furthermore, additional anecdotal reports from the diaries of all patients indicated that they were able to expose themselves to sunlight, without suffering the characteristic pain of EPP.

EPP is currently one of four key indications that Clinuvel is investigating to pursue market approval of CUV1647. With these favourable results, Clinuvel intends to advance to Phase III as soon as possible, pending regulatory approval.

Background to the disease

EPP is a genetic condition characterised by severe light-sensitivity (phototoxicity) of the skin. It is a rare disorder (caused by a fault in heme synthesis) that affects between one in 200,000 and 750,000 people. This condition mostly occurs in people with a fair-skinned complexion and is characterised by excruciating pain, swelling, and scarring (mostly hands and face). Typically, the pain experienced by these patients requires treatment with analgesics or antiinflammatory agents throughout their lives. EPP patients are often forced to remain shielded indoors, a lifelong behaviour that gravely affects their lives.

Results

The open label trial began in September 2006 at Triemli Hospital in Zürich, Switzerland. In the trial a controlled source of polychromatic light (light of multiple wavelengths) was used to emulate exposure of the skin to natural sunlight. Patients with clinically confirmed EPP were administered CUV1647 via two subcutaneous resorbable implants at two months intervals.

In all 5 patients, the time to provoke pain (photoprovocation) was markedly prolonged (range: 384% - 1266%). The difference between the measurements of the photo-provocation times on days 0, 30, 60 and 90 days was statistically significant (p=0.0069). The increase in melanin density in EPP patients measured on days 0, 30, 60 and 90 (measured at six anatomical sites) yielded statistical significance (p=0.0029).

Discussion of the results

Despite the limited number of patients in this trial, significance was obtained which indicated the potential efficacy of CUV1647 as a photo-protective drug for EPP patients. This potential efficacy was confirmed by the diary reports of all 5 patients.

As a result of this clinical outcome, Clinuvel has decided to advance its clinical program in EPP by conducting multicenter trials in the near future in both Europe and Australia. This decision will accelerate the development of CUV1647 by proceeding directly to a multicentre trial in EPP, under conditions of use, i.e. in spring and summer, when these patients suffer the most.

Clinuvel’s CEO, Dr Philippe Wolgen said:

“This is an important outcome for us as it is a preliminary demonstration of efficacy in a new clinical indication for the company. It is both promising and exciting that we may have demonstrated the potential to improve ‘quality of life’ in a group of patients who do not seem to have a remedy for their incapacitating disease. One should know that infants affected by EPP most often suffer an isolated childhood due to their undiagnosed, severe pain. It often takes years of suffering and withdrawal before their parents and physicians recognise EPP. Notwithstanding the encouraging outcome so far, this study was not placebo controlled. The conclusive evidence will only come when we administer the drug in the upcoming multicenter controlled trials, under environmental conditions during the seasons.”

These trial results further add to the safety and efficacy profile of CUV1647.”

- End -

Appendices can be found in the attached PDF.

Investor relations contacts:

Australia: Clinuvel Pharmaceuticals Limited, T: +61 3 9660 4900
Europe: Clinuvel AG, T: +41 41 767 45 45
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Clinuvel is an Australian biopharmaceutical company focussed on developing its photoprotective drug, SCENESSE® (afamelanotide) for a range of UV-related skin disorders resulting from exposure of the skin to harmful UV radiation. Pharmaceutical research and development involves long lead times and significant risks. Therefore, while all reasonable efforts have been made by Clinuvel to ensure that there is a reasonable basis for all statements made in this document that relate to prospective events or developments (forward-looking statements), investors should note the following:

  • actual results may and often will differ materially from these forward-looking statements;
  • no assurances can be given by Clinuvel that any stated objectives, outcomes or timeframes in respect of its development programme for SCENESSE® can or will be achieved;
  • no assurances can be given by Clinuvel that, even if its development programme for SCENESSE® is successful, it will obtain regulatory approval for its pharmaceutical products or that such products, if approved for use, will be successful in the market place

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