When Dr. Miriam Kidron, a scientist from Hadassah University Hospital in Jerusalem, first announced that she and a group of fellow researchers planned to bring an oral insulin for diabetics to market, most people thought the idea was ridiculous.

It took 25 years of research and a great deal of pure determination due to poor funding, but now Kidron is proving her detractors wrong.

Insulin, a hormone that helps controls glucose levels in the body, is a protein that breaks down in the digestive system, making absorption of insulin into the blood circulation weak, and the idea of oral insulin pills or tablets inconceivable.

Oramed Pharmaceuticals, the company Kidron’s son, Nadav, founded in 2005 to commercialize her research, is now in the midst of phase I clinical trials at Hadassah for what promises to be the world’s first oral insulin treatment for Type 2 diabetics.

Diabetes is a condition in which the body cannot effectively control the level of glucose in the blood. It can lead to serious complications such as heart disease, strokes, amputations, eye and kidney damage, and premature death. It is a modern epidemic and requires constant and often unpleasant monitoring and drug therapy.

In the US alone, 20.8 million people (seven percent of the population) are known to suffer from diabetes, and the number is growing dramatically as obesity – one of the causes of the disease – rises.

The World Health Organization (WHO) estimates the number of people suffering from diabetes worldwide now stands at 200 million, and believes this figure will rise to 370 million by 2030.

Of those who suffer diabetes, 10 percent have type 1 diabetes, – they are born with the disease and must take insulin injections to survive, and 90 percent have type 2 – where they develop the disease later in life. Most type 2 diabetics produce less than requested insulin, or the insulin in their bodies does not work properly.

Type 2 diabetics can treat the disease initially through diet alone, and then begin a combination of diet and medication. Most, however, end up dependent on insulin injections.

“Once a patient comes to a doctor with high glucose in their blood, it’s only a matter of time before they start taking medication,” says Nadav Kidron, Oramed’s CEO. “As the body is missing insulin, these medications make the pancreas produce more insulin. They overwork a system that is already not working very well and at the end of the day, the pancreas just can’t cope. As the dependency on insulin or alternative medicines rise, the pancreas gradually loses its ability to produce insulin. At this stage, insulin injections become necessary. It may take between two to 10 years, but it will happen.”

The Oramed Insulin Capsule is an orally ingestible soft gel insulin capsule that the company believes will help Type 2 diabetics reduce the dependency on insulin shots and even prevent them from needing them at a later stage of the disease.

The capsule has been specially engineered to protect the insulin from the destructive effects of gastric juices. The insulin it delivers goes straight to the liver, which stores insulin and controls the dose being delivered to the body, and from there is sent out into the bloodstream.

“The advantage of this,” Kidron told ISRAEL21c, “is that the route of the insulin from our capsule imitates the real route taken by the body. When you inject insulin it goes straight to the bloodstream and the liver has no control over it. Hence you become insulin dependent. In our case, the liver only releases the amount of insulin that the body needs. Our insulin compliments the insulin that the body is already able to produce so that a patient never becomes insulin dependent. It mimics the physiological delivery of insulin. It’s a real revolution.”

The company believes the oral therapy, which would replace existing medications used by Type 2 diabetics early in their disease, can preserve and possibly enhance pancreatic and liver function. “We believe that people who take the capsule will be able to avoid having to take insulin injections later in the disease,” says Kidron. “Hopefully they will never have to inject, but this capsule will help them control insulin levels for the rest of their lives.”

If the capsule works it could possibly benefit tens of millions of people.

Kidron – a lawyer by training – decided to found Oramed, after his mother, a pharmacologist and biochemist who is one of the leading experts in the field of oral delivery of peptides and insulin, came to him two years ago and told him that she and her fellow researchers from the Diabetes Unit of Hadassah (one of whom has died since then, and another retired) had made a breakthrough in their research.

“My mother was worried that bureaucracy would prevent people from enjoying the benefits of her research, so I took it upon myself to work on it, negotiate with Hadassah, and get a company together,” says Kidron.

Oramed was set up with funding of $2 million from angel investors including Zev Bronfeld, a well-known player in the Israeli biotech industry. The company has since raised a further $3 million in investment, also from private investors.

In April 2006, the company took part in a reverse merger with a shell company on the NASDAQ stock exchange. “We understood at the time that we will need to raise a lot of money, tens of millions of dollars, and that raising it from VCs would be a very hard and long process,” says Kidron. “We felt as a public company we would get liquidity and it would open us up to more investors.

“We also felt that this was a long-term goal anyway, and that if we started early, we wouldn’t have to lose time in the future but would be ready for all the next steps,” he continues.

Since the company was founded, it has held a number of animal trials which have all been successful. The company, which is based in Hadassah, began Phase I clinical trials of the capsule there in May. The trials will include a small group of healthy human volunteers, and will evaluate the safety of the drug. The trials are expected to be completed in about eight months. If successful, Phase II and Phase III clinical trials will follow.

Though Oramed remains small – just six full-time staff including Kidron and his mother, who is the company’s chief scientist – there has been a great deal of interest in the company.

In 2006, the diabetes market was worth about $14 billion, and the Type 2 diabetes therapeutic market is expected to exceed $15.3 billion in 2013.

“Once we show good results from Phase I, I don’t think money is going to be an issue,” says Kidron. “Everyone understands the potential of the monetary side of this capsule.”

For Miriam Kidron, however, the money is definitely not the issue. “This is her life dream,” says her son. “She goes to meetings now and everyone talks about the money, and she says she’s not interested in it. She just wants people to enjoy the benefits of it. Everyone is surprised by her attitude.”

Kidron is very optimistic about Oramed’s future. The company is pursuing the development of oral delivery solutions for other drugs and vaccines currently delivered by needle, but the oral insulin capsule holds out the most promise.

“I think the future is very clear,” he says. “In a few months we will publish the results from Phase I, and if they are as good as we expect them to be, then within three years we will have a product out there that’s working very well. This is a very short time to market and a very exciting development for the industry.”

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