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iPSC MSC ESC Differentiation
 
Injecting Stem Cells Into Brains
Wednesday, 12.23.2009, 02:11pm (GMT-7)

Dec. 23 (Bloomberg) -- A neurosurgeon at Southern General Hospital in Glasgow, Scotland, plans to drill a hole in a patient’s skull, insert a needle and inject 2 million stem cells from ReNeuron Group Plc into his brain early next year.

The patient is the first of 12 men disabled by strokes who expect to receive from 2 million to 20 million stem cells grown from the brain of an aborted 12-week-old fetus. The men would be studied for two years to see if the cells help the brain repair damage, without causing further harm.

ReNeuron won U.K. government approval in January to test its ReN001 stem-cell line after three failures to get permission from U.S. regulators. Preliminary analysis of the study next year will determine whether Guildford, England-based ReNeuron can continue developing the treatment and may also determine the viability of the company, whose market value is 19.9 million pounds ($32 million).

“The facts are it certainly may fail,” said Michael D. West, who founded Geron Corp., the first company to use human embryonic stem cells after they were discovered in 1996, and now is chief executive officer of BioTime Inc., a biotechnology company in Alameda, California. “The risks of this and other cell-based therapies are currently unknown.”

ReNeuron faces financial pressure as well: The company has access to 7.1 million pounds ($11.5 million) in cash, enough to keep running until mid-2011, which isn’t long enough to see final data from the trial. The company says it aims to begin the study early next year, and is awaiting government signoff on trial details.

Potential Market

ReNeuron closed unchanged at 5.83 pence in London trading yesterday. The shares have more than doubled in 12 months.

There aren’t any treatments to reverse the disability caused by strokes, which occur when there is a sudden loss of blood to the brain. Every year, about 5 million people worldwide are disabled by strokes, according to the World Health Organization in Geneva.

The price of an effective stem-cell treatment may be $20,000 and the potential market $3 billion, assuming it is suitable for 1 million people and that 15 percent of them can afford it, said Vadim Alexandre, an analyst at London-based Daniel Stewart & Co., which helped ReNeuron raise money this year.

Halving the Odds

The odds that any treatment in an early-stage safety trial will eventually progress to the market are about 10 percent, according to Alexandre. He said he halved that probability to 5 percent for ReN001 because of the novelty of cell-based treatments. After the U.K. regulator authorized the trial in January, Alexandre recommended that investors buy shares of ReNeuron, citing the “large potential market” if the product is one day approved. The stock may more than double to 13 pence in the next year, he wrote on Nov. 26.

Stem cells are the building blocks of life and researchers around the world are studying them to see whether they can cure disease. Those derived from embryos have the ability to become any of the roughly 210 types of cells in the human body. Fetal stem cells are grown from tissue taken from a fetus, which an embryo becomes eight weeks after conception.

The biotechnology company’s trial will be the first to use fetal stem cells for treating stroke in humans, after successful tests in rodents. Other trials have used stem cells derived from a patient’s bone marrow, fetal pig brain cells or tumors grown from germ cells, the precursors to eggs and sperm. None has proceeded to mid-stage trials after encountering safety or financing problems.

Biocompatibles Study

Biocompatibles International Plc, of Farnham in the U.K., is delivering stem cells from other patients’ bone marrow to stroke patients through a removable inch-square “tea bag” device in a safety trial in Germany.

Stem Cell Therapeutics Corp. of Calgary was ordered by North American regulators last year to halt human tests of its stroke treatment, which uses patients’ stem cells to stimulate growth of new brain cells, for safety reasons.

ReNeuron has accumulated losses of 26.6 million pounds since its founding 12 years ago. It generated revenue of 93,000 pounds last year from sales of non-therapeutic stem cell products for use in research. The company raised 3 million pounds through a stock sale in the first half.

The company will be spending cash and require additional funding, posing “a material uncertainty which may cast significant doubt over the ability of the group to continue as a going concern,” wrote PricewaterhouseCoopers LLP in an auditing opinion dated July 23. Matrix Corporate Capital LLP agreed in November to provide ReNeuron as much as 5 million pounds over two years.

War Chest

“We’ve never had a huge war chest,” CEO Michael Hunt said in an interview on Oct. 28. The company had 2.15 million pounds in cash at Sept. 30.

ReNeuron plans to test the same fetal stem cell line for peripheral artery disease, Hunt said. The condition occurs when vessels in the extremities harden, blocking arteries and reducing blood flow to limbs. The company will begin discussions with regulators, probably in the U.S. or Europe, Hunt said. If ReNeuron obtains approval next year, the trial may start in 2011, he said.

ReNeuron researchers and the Bristol Heart Institute in England found that the company’s stem cells improved blood flow to the legs of mice 21 days after their femoral arteries were blocked. The results of the study were presented at the American Heart Association conference in Orlando, Florida, on Nov. 15.

Three-Year Quest

The procedures in the stroke patients will complete ReNeuron’s three-year quest to begin testing its therapy, which comes from a stem-cell line grown from a tissue sample taken in 2003 from the brain of an aborted fetus. ReNeuron can grow all the cells needed for treatment from the single tissue sample, averting the need to collect more.

The company has slowed or stopped work on the eye disease retinitis pigmentosa, Parkinson’s disease and diabetes to save money and focus on the stroke trial, Hunt said. It has cut staff to 15 from 45 since 2007 and reduced research and development spending by 39 percent last year, saving about 2 million pounds.

The U.S. Food and Drug Administration in 2008 placed the stroke trial on clinical hold, citing safety issues associated with putting cells from a human fetus into a person’s brain for a nonfatal condition, Hunt said.

Safety Test

The company has been negotiating safety aspects of the trial with the U.K. government’s Gene Therapy Advisory Committee since February. The panel gave the company a favorable opinion, subject to the provision of more data and compliance with clinical protocols, Hunt said.

Once ReNeuron satisfies the committee, Keith Muir, a neurologist at the University of Glasgow, will recruit patients, a process Muir said will take at least two months. No more than one patient can be treated in a month, he said.

Complications such as bleeding or injury to the brain are Muir’s biggest concern, he said. Introducing foreign cells into a patient’s body also could lead to immune rejection or swelling. Muir said those risks didn’t appear in rodents or in Parkinson’s disease patients who have undergone fetal brain tissue transplants.

“We’ve had a long discussion with people who are experts in immunology and transplant rejection and it seems highly improbable that there’s going to be any clinically important reaction,” Muir said.

Another potential risk is cancer. Stem cells may work because they are capable of multiplying, much as cancer cells do. The key to their use is controlling their growth, a process that researchers don’t understand completely.

‘Chemical Switch’

ReNeuron has modified the ReN001 stem cell line with a gene called c-myc to provide a “chemical switch” that enables doctors to control the cells’ growth by adding or removing the drug tamoxifen. That gene is associated with cancer, said Sean Savitz, a neurologist at the University of Houston. Whether it will produce tumors in patients won’t be known until years after the trial.

The company is enrolling only men in the trial because the drug needed to activate or inactivate the gene may have risks for certain women, said Hunt and John Sinden, ReNeuron’s chief scientific officer. Women may be added at a later stage of testing.

If ReNeuron does show promise in either trial, the company may attract attention from bigger drugmakers. In the past year, Pfizer Inc., based in New York, said it would invest $100 million in the field over five years and GlaxoSmithKline Plc, based in London, said it would fund $25 million of research at the Harvard Stem Cell Institute in Cambridge, Massachusetts.

“The big deals will occur when they have substantial data,” said Navid Malik, an analyst at Matrix. “Two years out, that could be a possibility.”

To contact the reporter responsible for this story: Andrea Gerlin at agerlin@bloomberg.net

bloomberg.com

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