In phase 2b for developement of drug ("Melatonin")that produced...

In phase 2b for developement of drug ("Melatonin")that produced full body tanning. Thus eliminating the need to use fake tan, also in Australia the use of this product would reduce skin cancer since a tan is produced without UV damage to cells (ie. what causes aging of skin and also skin cancer) giving a person's skin natural protection from damaging UV rays.

Drug works. Is being currently trialed to measure how much skin protection the drug produces when used when UV light is received by the skin. Another clinical trial will soon start examining the delivery methods, eg a small chip of drug placed under the skin to give a tan via slow release of the drug.

Capped at $14million, it is the cheapest Australian drug company with a product in phase 2b clinical trials and has a cash balance still of $3million. The 2b trial is very cheap, because it is considering a preventive therapy rather then a therapy.

Currently also developing other revenue streams, with Stan Mcleish (former General manager of pharmacticals CSL limited) in the dermatological product range.

In March 2002, it completed phase 1 and phase 2 to show that the drug works and causes no side effects. Note that it is aimed at worldwide commercialisation, and there is not other drug currently which matches what it can deliver.

A rule of thumb that it generally takes 15 years to bring a drug from discovery to the market place, melatonin (the drug) was first patented in 1990.

The likely upside would occur in these stages if a major drug company would partner....

Recent news articles



SUN HERALD The tan that comes straight out of a needle
December 08, 2002

By Kate Cox
The Sun Herald in Sydney

HUMAN trials of a tanning drug that stimulates melanin production and drastically darkens skin colour will begin in NSW next month.
If they are successful, a glowing tan could soon be only an injection away.

The trials, to be conducted by Professor Ross Barnetson, of the University of Sydney, at the Royal Prince Alfred Hospital, mark the final stage of a 12-year research and development project.

But it is likely that Melanotan, dubbed the Barbie drug, won't be available until 2005, and then only on prescription.

Melanotan stimulates the production of melanin the dark pigmentation that is the body's natural defence mechanism against skin damage from exposure to sunlight and UV rays to gradually develop a deep tan that can last for months.

An American trial has already been successful and Melanotan has produced major colour change in animals.

This study will also determine the ability of the drug to reduce the degree and toxicity of sunburn in 80 volunteers, who will be exposed to UV rays before and after a regime of Melanotan.

"Part of what we do can be considered cosmetic," said Wayne Millen, chairman of Melbourne-based biotech company EpiTan, which has the world rights to develop Melanotan as a tanning agent.

But he believes that the drug would have massive health benefits, as darker skin offers more natural protection from the sun and UV rays.

People with high levels of melanin have a far lower incidence of skin cancer than those with fair skin. It has been proven that cancer rarely strikes individuals with Skin Phototype V-VI, such as darkly pigmented African-Americans, who are protected from skin cancer by adequate amounts of melanin.

"Your tan is really your internal sunscreen," Millen said. "That's the whole purpose of a tan, not to look cute down at Bondi."

"But the body doesn't do it by itself, it has to be inspired to do it."

The obvious question, then, was what happens if you could tan someone without exposing them to sun or UV rays?

"It took a lot of doing," Millen said. The only side effects facial flushing and a queasy stomach resulted from injecting all of the drug rather than slowly releasing it via a capsule that sits under the skin. Users would have a strong tan after a week, he said.

Critics have complained that this is yet another drug aimed at the wealthy, while others say that a hormone-altering drug can never be completely safe.

And, although EpiTan listed on the stock exchange in 2001, its shares have performed poorly.

But Millen said the finished product would answer the sceptics.

"Some people are saying that no tan is safe, but the world used to be flat as well," he said.

How does Melanotan work?

Exposure to ultraviolet light damages skin. To overcome this the body produces a substance called alpha-MSH (melanosyte), a stimulating hormone that produces melanin, which causes the skin to tan. Melanotan mimics alpha-MSH, but is 1,000 times more active and lasts longer in the body.

GLIMMER OF HOPE IN THE BATTLE AGAINST A DEADLY DISEASE

* Australia has the highest rate of skin cancer in the world.

* Two out of every three Australians will be treated for skin cancer.

* Skin cancer costs our health system more than $500 million per year (more than any other cancer).

MELANOTAN

* The drug is basically a synthetic copy of a naturally occurring tanning agent, a hormone called

Alpha-MSH, which the body produces after sun exposure.

* While the Australian study will look at distributing the drug via a slow-release implant under the skin, scientists suggested it could be administered through an injection, pill, patch or nasal spray.

* They predict it will be on the Australian market in 2005.

HERALD SUN Faking day in the sun
January 16, 2003

Healthwatch
By SOPHIE ELSWORTH

BRONZED bodies seem to be everywhere at this time of year.

Despite our raised awareness of skin cancer, many people still desire a tan, believing it makes them look healthier.

And as technology advances, getting that glowing look may even mean avoiding the sun altogether.

A new drug, to hit the market in a few years, promises the prospect of a sunless tan.

Without the use of fake tans or visiting a solarium, this new drug -- dubbed the Barbie drug -- is a Melanotan implant placed under the skin by injection.

The drug induces melanin, the skin pigment that creates tanning.

This pigment is the body's natural defence mechanism against skin damage from exposure to sunlight and UV rays and can gradually develop a tan lasting months.

Developed by Melbourne-based company EpiTan, it will be tested this year.

EpiTan clinical development manager Stuart Humphrey said it was important for users to understand that Melanotan was safe.

``We are aiming to show people that the implant protects the skin from sunburn, and at the same time we are encouraging the use of sunscreen to prevent sunburn,'' he said.

The implant is injected under the skin in a soft area such as the abdomen or underarm, and the drug is slowly released into the bloodstream over a month.

It is not an expensive process, and Dr Humphrey expects the price to be similar to one month's cost of attending a solarium, between $100 and $200.

Melanotan does slowly fade like normal melanin, but by keeping up normal habits of being in the sun the tan will not be lost.

In the winter months when there is less exposure to sun, it will fade like a normal tan and this may require another implant.

``It doesn't wash off because melanin stays within the cells in the skin, but as new cells develop, the tan will fade,'' he said.

But Victoria Cancer Council's SunSmart campaign manager Craig Sinclair said he didn't see great value in the product because it was still in the testing phase.

He said the drug's side effects were unknown.

Mr Sinclair said he was concerned that if people used it they would not adopt sun protective measures such as applying sunscreen because they believed the implant was sufficiently protecting them from sunburn.

Melanotan will be available from chemists by prescription, and EpiTan hopes it will hit the market by 2006.

Other forms of tanning include solariums and fake tans.
Solariums have become increasingly popular, but, according to SunSmart, going to a solarium exposes you to concentrated doses of UV, which result in visible signs of ageing and increases your risk of skin cancer.

Fake tans are also a common method of gaining a quick all-over golden glow.

But SunSmart believes such products cannot provide satisfactory sun protection even if they contain sunscreen.
The protection only lasts for about two hours after application like a normal sunscreen.

SKIN CANCER AND VICTORIANS
Melanoma is the third most common cancer in women, after breast and colorectal cancer, and the fourth most common cancer in men, after prostate, bowel and lung cancer.

1652 Victorians developed melanoma in 1999.

21% of these Victorians diagnosed with melanoma were under the age of 44.

Melanoma is the most common cancer in men and women aged 15-24 years, making up more than onethird of all new cancer cases for this age group.

Victorian women have a one in 34 risk of developing melanoma. Victorian men have a one in 33 risk of developing melanoma.
Since 1982, melanoma incidence rates in Victorian women have climbed and then plateaued. Incidence in Victorian men continues to rise.


Source - www.epitan.com.au