re: cancer vaccines .. m5 the little mouse Share Price ... Low,...

re: cancer vaccines .. m5 the little mouse Share Price ... Low, low today,

Interesting article July 2006 by science journalist Carmelo Amalfie Perth ...

QUOTE...
The little mouse who wouldn’t say die
26 July 2006by Carmelo Amalfi
Cosmos Online

The Devil's apple, or Solanum linnaeanum has an active ingredient which shows early promise as a cancer treatment.
When a little laboratory mouse refused to die of mesothelioma, an Australian biotech company suspected they might be on to something big.

Laboratory rats rarely retire. For most ‘guinea pigs' of science, death by disease or drug overdose is the only way out of the experiments.

But what happens when one of the subjects survives all the tests? And not just once, but twice.

For starters, share prices jump and so do the hopes of thousands of asbestos-related mesothelioma sufferers around the world.

Meet Mouse Number Five, the humble little lab mouse that survived one of the world's nastiest and incurable industrial diseases.

Known as M5 to his lab mates, the ‘miracle' mouse is still living it up on free cheese in quarantine - a living symbol of what can be achieved when biotechnology and business mix, according to Solbec Pharmaceuticals general manager David Sparling.

M5 made the front page last year when the Perth-based company announced that the infected lab mouse recovered from mesotheliolma after he was administered drugs made from compounds extracted from the fruit of devil's apple, a noxious weed introduced from Africa to Queensland in 1801.

The plant-based drug they developed, coramsine, ‘cured' M5. He also survived after he was re-infected with the normally deadly disease – suggesting that coramsine gave him lasting immunity by boosting or ‘priming' the immune system to respond to tumour attacks.

Sparling said the same result had been observed in limited trials of terminally ill patients in WA, whose tumours either shrunk or disappeared: "M5 represents a significant step in our mesothelioma research. It did not mean it would work in humans, but it did not mean it wouldn't."

Mesothelioma is a malignant growth in the cells that line a patient's body cavities including the chest, abdominal region or tissues surrounding the heart. It is typically associated with exposure to fine fibres of asbestos used for decades in Australia in the manufacture of building products now at the centre of the nation's biggest industrial health scandal.

Up to 45,000 people are expected to die from mesothelioma over the next 15 to 20 years, with more than 2500 Australians a year diagnosed with untreatable asbestos-related diseases such as mesothelioma.

One of five mice infected with the disease as part of Solbec's phase one trials to prove coramsine's safety and level of toxicity, M5 has now moved on to greener pastures - one of the lucky few lab rats set to die of natural causes.

Two other mice pulled through the phase one toxicity trials, but died of an overdose. And another two were put down after their tumours shrank, then returned.

Sparling said the focus now was repeating the M5 test results in national clinical trials over the next 12 to 24 months. Not on mesothelioma, but two other killers of Australians - malignant melanoma and renal cell carcinoma.

He said the trials will take the company's drug therapy treatment from phase one to phase two trials, proving efficacy in people. They will involve up to 60 patients with malignant melanoma and up to 60 patients with renal cell carcinoma from hospitals in every state and territory.

From there, if successful, Solbec moves to phase three - taking the drug to the marketplace. Originally incorporated as a mining company (Britannia Gold), Solbec was re-listed as a biotechnology company in 2001.

Sparling said it was best to have phase two results before little biotechs such as themselves establish partnerships with much bigger companies with the resources and marketing channels to take it through to consumers worldwide.

Solbec in Perth employed 16 people specialising in the development and commercialisation of therapies for life threatening and debilitating diseases and disorders, including biopharmaceutical compounds for the treatment of cancers such as melanoma, renal cell carcinoma and malignant mesothelioma. Devil's apple is one of those "therapies".

Known in scientific circles as Solanum linnaeanum, the Devil's apple's active compound, coramsine, consists of two main compounds, the glycoalkaloids solasonine and solamargine, which act by binding to a receptor on the cancer cell and rupturing the cell wall, causing the cell to die.

Solbec has located a receptor it believes is common to most cancer cells. Studies at the University of Western Australia have shown activity against ovarian cancer, renal cancer, melanoma, mesothelioma, colorectal and colon cancer, gastric cancer, bladder cancer, various skin cancers and prostate cancer.

The applications of devil's apple in combating cancer was tested and patented in the early 1980s by Bill Cham, who was then a medical researcher at the University of Queensland.

Cham, who developed a cream made from the devil's apple flower, followed up anecdotal evidence from livestock owners that the growth of skin cancers and lesions had slowed down or cleared up in horses and cattle that ate the weed.

Farmers also were known to rub the sap of the fruit to the back of their hands to stop sunspots.

Solbec runs a devil's apple farm on a 6 ha property, 40 km south of Perth. The perennial flowering plant is grown, harvested and transported to a plant where the glycoalkaloids are extracted.

Solbec outsources the final stages of the manufacturing process to reduce infrastructure costs by sending the glycoalkaloids in powder form, and roughly 99 per cent pure, to be further processed in Melbourne. The glycoalkaloids are split, then re-blended to improve the purity. One acre of land (0.4 ha) can provide enough fruit to make 80,000 doses a year.

The next year of production will include supplying doses for the national trials. Sparling said patients will be administered coramsine on a cycle of five days on and nine days off, receiving one injection a day directly into the largest vein in the body. Most patients are in their 50s and 60s.

Coramsine also is being applied in a parallel study of terminally ill patients in Western Australia under the Therapeutic Goods Administration's Special Access Scheme. The Federal Government ‘compassionate use' scheme allows patients who have tried all accepted therapies without success to access experimental medicines not yet in the market place.

Some of the 30 to 40 cancer patients treated so far under the scheme were given months to live, some went on to live for more than a year when given coramsine.

Sparling said the research and development involved in proving coramsine was, "tough, long and arduous".

"The whole biotechnology sector is struggling," he said.

"In the meantime, we are helping people. It's important we do this work. I also think the biotechnology sector will not stay soft for good. Though the risks can be high, there are potentially lucrative returns to be made in this business."
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