breakthrough in bid to prevent diabetes, page-5

I just hope that AOP’s cash burn of $8million a year or $2 million a quarter can be reduced by their sale of skin care products. If not, they will be diluting the shares once again next year by raising more capital. The article from the Bulletin states that they are a long way off from developing their oral insulin and that there is problems with controlling the dosage.


If anyone did not access the article from the Bulletin in June, here are some key paragraphs:

Apollo is one of several companies around the world developing oral insulin products to replace needles.

Dr Neville Howard, president of Diabetes Australia (NSW), says diabetics and doctors will welcome oral insulin but warns it has proven difficult to develop. "[Researchers] have been trying to develop oral insulin for a long time and most have fallen over because insulin is unique in hormones; the dosage has to be very precise," he says.

"Too much is dangerous and too little doesn't work. That has been a problem for at least two decades for researchers trying to get oral insulin."

Professor Lesley Campbell, a clinician and diabetes researcher at the Garvan Institute, agrees a tablet may not be sophisticated enough to get dosages and regulation of insulin right, for example after meals. "Regulation of insulin therapy is the real challenge," she says.

The insulin tablets will be the first of Apollo's drugs to go into clinical trials. Priest expects to reach phase two in the next 18 months; faster than a typical trial because the delivery system, not the drug, is being tested. Apollo will then seek a development partner for larger, more expensive trials.

So I guess 18 months from Jun 07 is Dec 08, then there is the longer and more expensive phase 3 trials.


Here is the full version:


A new insulin tablet offers hope for an end to daily injections. By Katherine Fleming.

Putting an end to injections is one of the great aims of diabetes research, and biotech companies are scrambling to tap into a market worth billions of dollars. An insulin tablet that could potentially revolutionise treatment is scheduled to begin human trials in Australia later this year, testing technology developed by Sydney-based Apollo Life Sciences to overcome hurdles that currently require insulin to be injected.


More than 140,000 people in Australia have Type 1 diabetes (formerly called juvenile diabetes) and need up to four injections of insulin daily because their bodies don't produce it. Type 2 diabetes affects 900,000 Australians (about half undiagnosed). It can often be managed with weight loss and lifestyle changes, although insulin injections are required for some.

Apollo is one of several companies around the world developing oral insulin products to replace needles. Sprays and powders that can be absorbed through the lungs or walls of the cheeks are being tested overseas, but Apollo is keen to pursue an insulin tablet, which patients may find preferable. The tablet needs to beat two key barriers: insulin is destroyed by acids in the stomach unless protected, but any protective shield hampers its absorption into the bloodstream through the gut wall.

This month, Apollo filed a patent application for its Oradel technology, which it believes will solve both problems. The insulin is encapsulated in a tiny "transporter molecule" to protect it, which is then coated with a vitamin. Vitamins are naturally pulled through the stomach wall into the bloodstream, taking the molecule through as well. It then breaks down, releasing the insulin.

Apollo chief executive John Priest - former Coca-Cola Amatil chief financial officer and corporate development director - says the technology has been impressive in animal tests. "In our pre-clinical studies, the oral insulin has performed exceedingly well. It has taken insulin down to normal levels in diabetic animals and been able to hold it there for eight to 24 hours," Priest says. "The end result of that is a tablet a day."

Apollo has appointed three experts from the International Diabetes Institute to an advisory committee: Professor Paul Zimmet, Associate Professor Jonathan Shaw and Dr Matthew Cohen. Zimmet says the very early data indicates Apollo's method is one of the best prospects for developing oral insulin.

Dr Neville Howard, president of Diabetes Australia (NSW), says diabetics and doctors will welcome oral insulin but warns it has proven difficult to develop. "[Researchers] have been trying to develop oral insulin for a long time and most have fallen over because insulin is unique in hormones; the dosage has to be very precise," he says.
"Too much is dangerous and too little doesn't work. That has been a problem for at least two decades for researchers trying to get oral insulin."

Professor Lesley Campbell, a clinician and diabetes researcher at the Garvan Institute, agrees a tablet may not be sophisticated enough to get dosages and regulation of insulin right, for example after meals. "Regulation of insulin therapy is the real challenge," she says.

If those barriers can be overcome, the financial returns are likely to be substantial. "Currently, for all diabetes and for all treatments, the market is around $US18bn a year annually and it's growing at 40% per annum, which is a bit staggering really," says Priest. "Doctors are loathe to prescribe and people are loathe to use needles and so tend not to control their diabetes as well as they might. This will take that problem away."

While newer insulin products are used for injection, Priest says older versions of insulin can be used for the tablets, making it "cheap and easy and scalable to make".

Apollo plans to use the Oradel technology in trials of its anti-inflammatory therapy, which it hopes can replace injections for serious cases of conditions including arthritis and Crohn's disease. It's also working on ways to have molecules absorbed through the skin. This year, it announced it had successfully vaccinated mice against tetanus this way.

The insulin tablets will be the first of Apollo's drugs to go into clinical trials. Priest expects to reach phase two in the next 18 months; faster than a typical trial because the delivery system, not the drug, is being tested. Apollo will then seek a development partner for larger, more expensive trials.