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FarmaZutical Free

09/04/15 9:37 AM

Post #3

Please refer to the CLVLY board

Camaro1093 Free

11/04/09 1:08 PM

Post #2

For more information on the company and afamelanotide: www.clinuvel.com

GLTA.

Camaro1093 Free

11/04/09 12:49 PM

Post #1

Clinuvel Pharma: Three Prospective Game-Changing Events in Three Months -- http://seekingalpha.com/instablog/441189-mike-rabe/32145-clinuvel-pharma-three-prospective-game-changing-events-in-three-months

Clinuvel Pharmaceuticals (CUV.AX, CLVLY.OTC) is expecting to report on key binary events in the coming months – and as of right now, these binary events are flying under the radar in the biotech investing world. This presents an intriguing opportunity for those investors who are looking for a high risk / high potential reward play in biotech.

These events will be game changers – and they are all right around the corner. Let’s preview them:

1. Results from the Phase III EPP trial –

Clinuvel is banking on solid Phase III EPP (porphyria – absolute sun/UV intolerance) results from the current trials in Europe and Australia. The EPP trial is their lead trial for their first-in-class photoprotective drug, afamelanotide. Results are expected in within three months. Positive results will significantly de-risk the Company and should spawn several more accomplishments soon, such as trials in the US and a trade name for afamelanotide.

Note that in January 2009, the Company reported positive interim Phase III results for EPP.

2. Interim results from the Phase III PLE trial –

The PLE (polymorphic light eruption – sun/UV poisoning) indication for afamelanotide holds the largest potential on-label market for the drug. I’m personally putting more weight on the results of this trial than others are. If the PLE trial does not meet its primary endpoint, I would consider this a pretty big blow to the Company. Given there are a handful of clinical indications for afamelanotide, disappointing PLE results would not be deadly, but would certainly have a negative effect on shareholders.

Interim PLE results are expected in Q4 2009.

3. FDA Green Light for a USA Phase III trial –

It appears the Company is waiting for the FDA to grant clearance for a confirmatory Phase III EPP trial. Approval of this trial would be a watershed event for the Company for a couple reasons:

First, the Company would finally be on path to starting a major trial for afamelanotide on American soil, roughly 20 years after the synthetic version of the melanocyte stimulating hormone was first created by researchers at the University of Arizona.

Second, it is extremely rare for any Australian biotech company to achieve late-stage drug trial status with the FDA. The Company would be on path to entering the largest pharmaceutical market.

Clinuvel is hoping to begin a Phase III EPP confirmatory trial in Q2 2010.

*******

One thing is for certain – Clinuvel Pharmaceuticals is about to enter the most important 3-4 month period of its history. The above-mentioned binary events will determine much of the Company’s fate.

Disclosure: Long Clinuvel
Themes: Clinuvel, biotech, pharmaceuticals Stocks: CLVLY.PK

Clinuvel Pharmaceuticals Ltd (CUV)

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Who is Clinuvel Pharmaceuticals?

Clinuvel Pharmaceuticals, Limited is a Melbourne based biopharmaceutical company focused on developing its leading drug candidate afamelanotide.

Currently in Phase II and Phase III clinical trials, afamelanotide is being developed as a preventative photoprotective agent for five clinical applications:

1. Erythropoietic Protoporphyria (EPP)
2. Solar Urticaria (SU)
3. Photodynamic Therapy (PDT)
4. Actinic Keratosis (AK) and Squamous Cell Carcinoma(SCC)
5. Polymorphous Light Eruption (PLE)

What exactly is "Afamelanotide"?

Afamelanotide (formerly CUV1647) acts by increasing the levels of melanin in the skin; and shields against UV radiation (UVR) and sunlight. Afamelanotide is delivered via a subcutaneous dissolving implant approximately the size of a grain of rice. Increased pigmentation of the skin appears after 2 days and lasts up to 2 months. It is proposed that afamelanotide will assist those patients who are most severely affected by UV and light, with the aim of improving their quality of life.

Alpha-Melanocyte Stimulating Hormone (α-MSH) is a naturally occurring peptide hormone which is released by skin cells in response to the stimulation by ultraviolet radiation (UVR). α-MSH has a very short half life (seconds) in the blood stream, sufficient to reach and stimulate other skin cells (melanocytes) which in turn produce and release melanin, a dark brown pigment. Melanin is known for its photoprotective effect.

Afamelanotide is a chemical analogue of α-MSH. Afamelanotide is a linear peptide with 13 amino acids. Two amino acids present in α-MSH have been changed and amplified to produce afamelanotide. This small change creates a more stable molecule with increased potent biologic effects and a longer half life (minutes). Afamelanotide increases melanin content of the skin without exposure of the skin to the damaging effects of UVR.

Clinuvel's mission is to develop afamelanotide for the most severely affected groups of patients susceptible to phototoxicity and photosensitivity of the skin caused by UV, sun and light. Patients diagnosed with porphyria¹, polymorphous light eruption, solar urticaria, skin cancers and skin lesions², as well as patients undergoing photodynamic therapy treatment³ provoked by UV and light are clinically eligible to receive afamelanotide every two months.

Clinuvel Pharmaceuticals Ltd is an ethical pharmaceutical company focused on providing photoprotective care of the skin. Clinuvel is working closely with global regulatory agencies to develop afamelanotide as a prescriptive drug. The company intends to complete Phase III trials in late 2009. Clinuvel has been developing and testing afamelanotide since 2000. Its development is focused on the SAFE and controlled administration of the drug substance.

¹ Clinuvel is currently focused on prophylactic treatment of Erythropoietic Porphyrias in clinical trials of afamelanotide.
² Clinuvel is currently focused on preventing actinic keratosis and squamous cell carcinoma of the skin in organ transplant recipients in clinical trials of afamelanotide.
³ Clinuvel is currently focusing on systemic PDT treatments.

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