A corporate fact sheet on Clinuvel can be downloaded here (pdf format).
Investing in Clinuvel
How do I invest in Clinuvel in Australia?
How do I invest in Clinuvel in the USA or Europe?
When is the 2008 Annual General Meeting of Clinuvel shareholders?
How can I subscribe to Clinuvel's email updates?
Afamelanotide (CUV1647)
Why is afamelanotide (CUV1647) not currently available on the market?
When will afamelanotide (CUV1647) be available on the market?
What conditions does afamelanotide (CUV1647) aim to treat? What are your ‘clinical indications’?
Could afamelanotide (CUV1647) be used to treat Vitiligo or Rosacea?
How is afamelanotide (CUV1647) administered?
Will afamelanotide (CUV1647) give me a tan?
Clinical Trials
How can I register to take part in trials in Europe or Australia?
How can I register to take part in trials in the USA?
I want to volunteer for a trial, but don’t currently suffer from one of the clinical indications, can I still participate?
Investing in Clinuvel
How do I invest in Clinuvel in Australia?
Clinuvel Pharmaceuticals Limited is listed on the Australian Securities Exchange (ASX) under the symbol CUV, Clinuvel does not issue stocks directly to investors. Please contact a financial advisor for more investing information.
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How do I invest in Clinuvel in the USA or Europe?
Clinuvel stock is available in the USA through ADRs listed with the Bank of New York Mellon with the symbol CLVLY. Clinuvel stock is available in Europe through the Xetra listing UR9. Clinuvel does not issue stocks directly to investors. Please contact a financial advisor for more investing information.
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When is the 2008 Annual General Meeting of Clinuvel shareholders?
At present the 2008 AGM is scheduled for the first week of November. Clinuvel will announce the date to the ASX once it has been confirmed. To receive ASX announcements, please subscribe to our online database.
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How can I subscribe to Clinuvel's email updates?
Clinuvel maintains regular contact with our stakeholders via our email updates. Click here to subscribe.
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Afamelanotide (CUV1647)
Why is afamelanotide (CUV1647) not currently available on the market?
Afamelanotide (CUV1647) is a photoprotective in a development phase and not currently available on the market. It is currently being tested for its safety and efficacy in clinical trials.
In ethical pharmaceutical drug development a rigorous clinical program needs to be followed to comply with the requirements of regulators worldwide. Drug development therefore is not a speedy process. It takes time.
Ensuring the safety and efficacy of afamelanotide (CUV1647) is paramount to the program and Clinuvel is following an intensive clinical trial process in advance of pursuing regulatory approval and commercialisation to make this process as fast as possible.
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When will afamelanotide (CUV1647) be available on the market?
At present Clinuvel is on track to file for registration for its photoprotective, afamelanotide, in Europe, Australia and Switzerland some time in 2009. Clinuvel is working hard to meet this target, however pharmaceutical development is not a linear process. Ensuring the safety and efficacy of the drug is Clinuvel’s primary concern and until these two endpoints are met, afamelanotide (CUV1647) will continue to be trialed by Clinuvel.
At present it is not possible to speculate on a market date in the USA. By following Clinuvel’s clinical progress through the corporate website and the online mailing list, you will be kept abreast of any updates on this timeline.
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What conditions does afamelanotide (CUV1647) aim to treat? What are your ‘clinical indications’?
Clinuvel’s pioneering work aims to provide photoprotection, that is to assist those who suffer from three UV related skin disorders and two cancer related treatments. The five clinical indications that Clinuvel is currently testing afamelanotide (CUV1647) for are:
- Erythropoietic Protoporphyria (EPP) - absolute sun intolerance, intolerable pain suffered when exposed to light by between one in 200,000 and one in 750,000 people.
- Phototoxicity associated with Photodynamic Therapy (PDT) for cancer – a debilitating photosensitivity to sunlight and artificial light (skin and eyes) that can last up to 90 days after PDT treatment.
- Polymorphous Light Eruption (PLE/PMLE) – likened to sun poisoning. Suffered by 10 -20% of Population.
- Actinic Keratosis (AK), a precursor to skin cancers and Squamous Cell Carcinoma (SCC) - non-melanoma skin cancers - in organ transplant patients. Organ transplant patients who are fair skinned are 65 to 100 times more likely to develop skin cancer on prescribed immune-suppressant medication following their transplant, compared to the general population.
- Solar Urticaria (SU) – (acute) anaphylactic reaction to sun.
For more information on each condition, click here.
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Could afamelanotide (CUV1647) be used to treat Vitiligo or Rosacea?
Clinuvel is not currently testing for the indications of Vitiligo or Rosacea, and at present no clinical trials are planned for the foreseeable future. By subscribing to our database, you will receive company updates on any clinical trials.
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How is afamelanotide (CUV1647) administered?
It is anticipated that afamelanotide (CUV1647) will be administered by medical practitioners and delivered underneath the skin as a subcutaneous injection of a bioabsorbable implant that is approximately the size of a grain of rice. This type of administration allows the dosage of the drug to be carefully measured by the medical practitioners who prescribes it.
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Will afamelanotide (CUV1647) give me a tan?
Afamelanotide (CUV1647) is a photoprotective, it is not a cosmetic tanning product.
Clinuvel believes that afamelanotide (CUV1647) has the potential to improve the quality of life of the many millions of people worldwide who suffer from light related skin disorders and damage caused by UV radiation. Clinuvel is targeting a global problem that affects millions of people. We strongly support government and health care providers in their initiative to increase education about the dangers to UV-radiation and recommend that people follow their advice.
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Clinical Trials
How can I register to take part in trials in Europe or Australia?
Selection for clinical trials is not undertaken by Clinuvel but by the physicians at the clinical trial sites. You would need to contact these physicians regarding your suitability.
The clinical trials that Clinuvel is currently conducting for afamelanotide (CUV1647) are in specific patient groups and only for those patients suffering from one of the outlined clinical indications. As with all clinical studies there are strict inclusion and exclusion criteria for participating patients and only patients with designated diseases who meet these criteria are eligible for entry. By subscribing to our database, you will receive company updates on any clinical trials and the conditions of participation.
More information on Clinuvel's PLE trials is available on the ClinicalTrials.gov website.
More information on Clinuvel's EPP trials is available on the ANZCTR website.
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How can I register to take part in trials in the USA?
At present Clinuvel is not conducting trials in the USA. By registering with our database, you will be kept informed of whether this situation will change. Any trials that will commence in the USA will focus on the current clinical indications.
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I want to volunteer for a trial, but don’t currently suffer from one of the clinical indications, can I still participate?
At present Clinuvel is only looking for trial volunteers in the clinical indications listed on the site. Although we have conducted ‘healthy’ trials from time to time to test the efficacy or safety of afamelanotide (CUV1647), we are no longer seeking volunteers for such trials.
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