CUV 2.84% $23.50 clinuvel pharmaceuticals limited

phase 11b trial results

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    Company Announcement
    Phase Mb clinical trial an outstanding success
    For more information contact:
    Dr Wayne Millen, Managing Director, EpiTan Limited, Tel: 03 9662 4688
    Mr lain Kirkwood, Chief Administrative Officer, EpiTan Limited, Tel: 03 9662 4688
    Mr Richard Allen, Monsoon Communications, Tel: 03 9620 3333
    [email protected]
    Melbourne, Australia

    EpiTan Limited (ASX:EPT) today announced that the outstanding results recorded in its recently completed Phase lib "sunburn injury" clinical trial represent a massive step forward in the drug's commercialisation progress.

    EpiTan also announced that new data generated from this successful trial is being examined by medical and legal experts and is expected to be the subject of new patent applications. Consequently, to avoid compromising the company's intellectual property rights, full disclosure of data from the clinical trial is being withheld until the relevant patent applications have been lodged.

    The trial's key objective was the measurement of the effectiveness of Melanotan® on increasing skin melanin density and reducing sunburn injury. A major effect of sunburn injury is DMA and skin damage. The trial was performed at Sydney's Royal Prince Alfred Hospital and the Royal Adelaide Hospital.

    The double blind, randomised, placebo-controlled comparative study involved 81 Caucasian volunteers, 48 males and 33 females with an average age of 39.3 years. Prior to receiving Melanotan, the volunteers were subjected to controlled levels of UVA and UVB radiation onto a small area of skin resulting in a level of burning similar to spending 30-120 minutes in strong sun without sunscreen. A skin biopsy was taken to measure the level of resulting sunburn injury. After the volunteers had received the regime of Melanotan, they were re-exposed to the same UV radiation exposure, and another skin biopsy. Melanin density levels at various skin sites were monitored throughout the three month study period.

    Key information available from the trial data, that the company is in a position to disclose at this stage, revealed:

    • Clinically visible tanning was noted in a large proportion of volunteers;
    • The difference between the Melanotan-treated group and the placebo group was
    highly significant at all skin sites measured.

    • Importantly, the percentage increase in melanin density for fairer skin types
    (Fitzpatrick I/I I) was approximately double that for those with darker skin types
    • Only 6 volunteers, or 7.4% of the total, thought they had Fitzpatrick Skin Type I,
    (always burns/ never tans). After being measured clinically, 29 or 35.8% were
    assessed by the Investigators as Skin Type I.

    Dr Stuart Humphrey, Clinical Development Manager of EpiTan, said, "The key data regarding those volunteers with fairer skin types confirms that Melanotan may be effectively used as a prescription sunscreen to provide both UVA and UVB protection when commercialised. We are very excited about the trial results which provide substantial support for our understanding of melanogenesis.

    Melanotan is one of a new breed of pharmacogenomic drugs which is expected to be of significant benefit to those people with fair skin types who normally produce little melanin and consequently are most at risk of sunburn injury and therefore of developing skin cancers"

    Dr Humphrey also added, "It is worthwhile noting that half the number of volunteers who subjectively declared themselves as having the ability to tan and rarely burn (Fitzpatrick 11 I/I V skin type) turned out, in fact, to be Fitzpatrick Type I/I I (usually burn/ tan with difficulty) The use of Melanotan in conjunction with other skin protection methods should ensure that people have the ability to protect themselves better from the harmful effects of UV radiation".

    Dr Wayne Millen, EpiTan's Managing Director, said "This is a massive step forward and EpiTan is now in a very select group of Australian biotechnology companies with an advanced drug candidate on the road to commercialisation. Next month we start a dose escalation trial for the newly developed implant containing Melanotan. This trial is scheduled to conclude in May 2004, after which we will be in a strong position to advance our clinical trial programme towards Phase III."

    As previously announced, EpiTan is expanding its clinical trials into Europe to include the therapeutic indication of PMLE and expects to lodge an Investigational New Drug (IND) application with the Food and Drug Administration in order to open the path for clinical trials in the United States.

    ABOUT THE COMPANY: EpiTan Limited (ASX: EPT) is an emerging biotechnology company with a pre-eminent position on the prevention of DNA and skin damage from ultraviolet (UV) radiation exposure. Based in Melbourne, Australia, EpiTan holds a unique technology platform centred on its leading drug candidate Melanotan®, one of a new breed of pharmacogenomic drugs.

    The company has the exclusive worldwide rights to develop Melanotan which, like sunlight, stimulates the production of melanin in the skin or "melanogenesis" - a unique biochemical process. However, and most importantly, the body's melanin levels are increased before exposure to harmful UV radiation. This will become a new photo-protective tool which will be of significant benefit to people with fair skin types who are most at risk of sunburn injury and therefore of developing skin cancers.

    Melanotan concluded its Phase 11b clinical trials in September at two sites-the Royal Prince Alfred Hospital in Sydney and the Royal Adelaide Hospital.
    EpiTan has now successfully developed a more user-friendly drug delivery formulation of Melanotan in the form of a slow release implant. This will be used in the remaining clinical programme and the commercialised product.

    EpiTan is also investigating Melanotan as a therapeutic agent for other indications such as vitiligo, albinism and psoriasis and UV induced skin allergies such as polymorphous light eruption ("PMLE") and solar urticaria. PMLE is a significant UV induced skin allergy in northern latitudes.

    Potential markets worldwide for Melanotan for dermatology purposes are estimated at US$2.5 billion. An even greater market (more than US$5 billion) exists for Melanotan as a new safe (prescription) sunscreen drug. -End-
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