Drug trial may reduce sunburn/Australia 'needs stem cell bank'?

September 1, 2005

Might be good to create a pill that whitens skin as well so darker skin won't be subjected to such prejudice. How did Michael Jackson get so white? N

Thursday September 1, 06:45 PM

Drug trial may reduce sunburnhttp://au.news./050901/2/vr49.html

If you've got fair skin, getting a tan may seem dangerous, messy, time-consuming, expensive or perhaps, not worth the trouble.

Choose to lie in the sun or spend too long in a solarium, you risk sunburn, and potentially, skin cancer.

Opt for a fake tan and it usually only lasts a few days and can stain your clothes, sheets, towels.

But an Australian-based pharmaceutical company is trialling a slow release implant of its drug, EPT1647, which it says can tan light-coloured skin and reduce sunburn.

Epitan Ltd CEO Iain Kirkwood said EPT1647, brand name Melanatan, stimulated the body to make eumelanin, the dark pigment in the skin, without the need for sun exposure.

Mr Kirkwood said trials involving multiple injections of the drug had found it reduced sunburn by up to 50 per cent in fair-skinned volunteers.

"We've shown we can actually get a redhead to tan," he said in an interview.

The Melbourne-based company had since developed a long-acting injectable implant - considered a more commercial way of administering the drug - to release Melanatan into the body over a number of days.

A randomised controlled study is underway at Sydney's Royal Prince Alfred Hospital to test the effectiveness of the implant in healthy, light-skinned adults.

Half of the 48 participants will receive the EPT1647, a synthetic version of a naturally-occurring hormone, while the remainder will be given a placebo - inactive treatment.

Mr Kirkwood said he expected the implant to work for between 60 and 90 days.

Dermatologist Peter Foley, who sits on Epitan's advisory board, said although the drug stimulated production of the eumelanin, it did so without affecting the melanocytes, or cells in the skin which make the pigment.

"If you can take a medication that causes tanning, gives you some protection in the sun and reduces the need to go out in the sun to get a tan, dermatologists would support that," he said.

"But if it's perceived as something that if you have this injection, you can go and lie in the sun all day, dermatologists would be very disappointed at such a medication.

"This will be something extra in addition to the usual sun smart behaviour."

Apart from providing a safe tan, EPT1647 may also have a therapeutic benefit.

Mr Kirkwood said the company was testing the drug's effectiveness in patients with the UV-related skin disorder, Polymorphous Light Eruption (PMLE), sometimes referred to as sun poisoning.

A report into a pilot study of 18 PMLE patients in Germany, Finland and Denmark, is expected in October, and another trial of 30 people is awaiting ethics approval at St Vincent's Hospital in Melbourne.

In the most severe form, PMLE may cause a sufferer to avoid outdoor activities because of the intensely itchy rash that develops about 24 hours after sun exposure.

Preventative treatments include exposure to UV light for up to six weeks during spring to avoid flareups in summer, staying out of the sun and wearing protective clothing.

If that fails, doctors may prescribe steroidal creams or oral steroids, anti-histamines, anti-malarial medication or beta-carotene to treat symptoms.

Pending the results of the Melbourne and Sydney trials, Epitan Ltd plans final human studies in Australia and Europe next year.

They hope to be able to commercialise the drug in late 2007 or early 2008.

Focus initially will be on getting the drug approved by health regulators for use in PMLE patients.

"We've been working on PMLE as an unmet medical need," Mr Kirkwood explained.

But he also expects EPT1647 to have a huge off-label use for cosmetic purposes as a tanning drug.

"For younger people ... who want the brown legs and brown face, this will be very useful," Mr Kirkwood said.

He said side effects in trials using multiple injections included facial flushing, nausea and vomiting.

But he said the implant involved much lower doses, reducing such symptoms.

Mr Kirkwood said he expected EPT1647 to be very competitive when compared with the cost of fake tans and solarium visits.

"It'll be quite affordable," he said.

Epitan listed on the Australian Stock Exchange in 2001.

Thursday September 1, 06:45 PM

Australia 'needs stem cell bank'

Australia needs a national stem cell bank to help usher in a paradigm shift in medicine, a leading scientist says.

Professor Peter Rathjen says such a bank would aid creating a new generation of Australians who had high quality lives until they died.

Prof Rathjen, head of the University of Adelaide's department of molecular biosciences, said stem cell technology had vast applications.

He was giving evidence to the first sitting of an independent inquiry into Australia's human cloning and human embryo research laws, held in Adelaide.

"If this sort of technology is adopted in its broadest sense, then my view is it will be an utter paradigm shift in the way we think about medicine," Prof Rathjen told the inquiry.

"We will have a rational way of treating diseases that have not previously been treated.

"What you would find in 20 to 30 years time ... is the opportunity to treat diseases that at the moment we simply are completely able to address in an effective way."

Prof Rathjen said a national stem cell bank would help streamline scientific research.

"Science always responds well to standardisation and consistency," he said.

"I think we will be well served by a ... bank."

Prof Rathjen, also an Australian Stem Cell Centre researcher, said Australia's laws must reflect the potential of the technology.

"I can't really over-stress the impact I think it will have on society completely," he said.

"We may be able to produce a whole new generation of people, or forthcoming generations of people, who have a very high quality of life pretty much up to the time that they die.

"The markets for this sort of thing are very difficult to estimate but certainly would seem to in excess of $US100 billion ($A132.75 billion) per year.

"If Australia can get even a slice of that kind of action, that also would have a spectacular impact."

Prof Rathjen said technology remained in its infancy.

"The concept that you might be able to kill disease by transplanting cells is a concept," he said.

"The ways in which it may be applied for human welfare are many and various and none of us can yet predict where the earliest advances will be."

The independent inquiry, chaired by former Federal Court justice John Lockhart, has been appointed by the federal government to review Australia's Prohibition of Human Cloning Act and Research Involving Human Embryos Act, both of 2002.

The inquiry will hold public and private hearings around the nation before reporting to the government by December 19 this year