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    Investing In Clinuvel Q & A's

    Clinuvel maintains regular contact with our stakeholders via our email updates. These include ASX announcements, analyst reports and general news. Click here to subscribe.

     

    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.

     

    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.

     

    Clinical Trials Q & A's

    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 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.

    Anonymity is a key requirement for trial participation. By contacting Clinuvel, you may disqualify yourself from possible trial participation.

    More information on Clinuvel's confirmatory EPP trials is available on the ClinicalTrials.gov website.

    More information on Clinuvel’s AK/SCC trials with organ transplant recipients is available on the ClinicalTrials.gov website.

    In January 2009, Scenesse (afamelanotide) was allowed IND status by the Food and Drug Administration (FDA) to commence clinical trials in the USA on humans. In March 2010, the FDA allowed Clinuvel to extend its US program and commence a Phase II trial of Scenesse in EPP.

    Enrolment in this trial will be open only to those patients diagnosed with EPP. Clinuvel does not recruit patients directly for trials. Anonymity is a key requirement for trial participation. By contacting Clinuvel, you may disqualify yourself from possible trial participation.

    Patients diagnosed with EPP are advised to discuss trial candidacy with their dermatologist or physician who can contact a relevant trial site.

    The American Porphyria Foundation also maintains a register of individuals in the US with EPP and maintains close contact with physicians working in the field.

    Yes, Clinuvel commenced a clinical trial program in the US in mid 2009. In March 2010, the FDA allowed Clinuvel to extend its clinical program and commence a Phase II trial of SCENESSE® (afamelanotide) in erythropoietic protoporphyria (EPP).

    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 ofScenesse, we are no longer seeking volunteers for such trials.

    Clinuvel is aware of the theoretical potential of its drug to treat additional indications. At present, the company’s focus is on the five indications outlined on this website. Running clinical trials in multiple patient populations is an expensive and complex process, fraught with potential risk. To provide the best possible path to market for afamelanotide, Clinuvel has identified five indications and will focus on these at the present time. Any updates to our clinical development will be announced to the ASX and emailed to our subscriber database.

    Clinuvel is currently relocating its US office following the approval of the expansion of its US clinical program for EPP to mirror that of the EU and Australia.

     

    Counterfeit Q & A's

    No. SCENESSE® (afamelanotide) is often confused with illegal, untested and unregulated chemicals offered online for self-administration.

    The confusion lies in that vendors present injectable tanning products as SCENESSE® . In reality both the molecule and formulation of SCENESSE® have been optimised and altered and is not related to counterfeit products offered nowadays as Melanotan I and II.

    Peptides are sensitive molecules consisting of particular amino acids which need diligent and pure synthesis. During the decade of development of SCENESSE® various proprietary manufacturing processes have led to the current optimised product.

    Clinuvel’s formulation titrates the available quantities of SCENESSE® in the human body whereby maximum and minimum dosing has been carefully evaluated over the years. At picomol quantities, SCENESSE® is targeting specific skin cells to activate the process of biochemical photoprotection. SCENESSE® has no effect on other organs or the brain. SCENESSE® does not cause increased weight loss or libido.

    It is a well known phenomenon that the general public ‘falls in love’ with a drug before it reaches approval. However, there is no foundation for the recreational use of SCENESSE® as a self-injectable. Clinuvel’s proprietary drug is being administered by physicians for the purpose of medicinal photoprotection of the skin.