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Election to benefit some industries, harm others

Election to benefit some industries, harm others

By CHRISTOPHER S. RUGABER

November 3, 2008
AP Economics Writer

WASHINGTON (AP) — Battered by the financial meltdown, America’s business community is anxiously calculating how Tuesday’s presidential election will affect it.

Energy, pharmaceutical and telecommunications companies could face tax and other policy changes no matter who wins the White House. The outcome also could determine how well alternative energy developers, generic biotechnology companies, stem cell researchers and others fare.

Labor unions put major resources behind Democrat Barack Obama and could wind up a big winner if he takes the White House. Nuclear power and the coal industry would get a boost if Republican John McCain prevails. Obama promises to raise corporate tax rates and income taxes on families making over $250,000; McCain promises to cut corporate taxes and extend all of President Bush’s tax cuts.
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A look at how some could fare:

STEM CELL RESEARCH

Few sectors have more to gain on Election Day than the nation’s fledgling stem cell companies, which long have bemoaned the administration’s policy limiting federal money for embryonic stem cell research. Bush believes the research is immoral because the process of culling the stem cells kills the embryo.

Both Obama and McCain support federal spending on stem cell research and could move to overturn current restrictions. Industry executives say the policy change would shore up investor confidence in stem cell developers.

“It will relieve a lot of uncertainty among the investment community that we are going to become an outlaw industry,” said Richard Garr, chief executive of Neuralstem.

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FDA Hearings on Stem-Cell Drugs

FDA Hearings on Stem-Cell Drugs
By ALICIA MUNDY
April 10, 2008; Page D3

The contentious debate over embryonic-stem-cell research is entering a new chapter as biotech companies press the Food and Drug Administration to approve clinical trials for the first generation of stem-cell-derived drugs.

The FDA has set two days of hearings starting Thursday to discuss how the agency may regulate embryonic stem-cell therapies. FDA officials say they expect the hearing will draw a crowd of biotech executives, investors and researchers, and representatives of patient-advocacy groups.

The biotech industry and investors want more certainty about the FDA’s guidelines for the complex approval process ahead, and assurance that the FDA isn’t averse to approving embryonic-stem-cell therapies for political reasons.

One company involved in the hearings, Geron Corp., of Menlo Park, Calif., is set to file what it says is the world’s first embryonic-stem-cell proposal with the FDA. If approved, the company could begin human testing of a therapy to repair acute spinal injury. The company expects to submit its proposal this summer.

During a conference call with investors this year, executives touted the upcoming FDA panel. “We are actually playing a very central role,” said Chief Executive Tom Okarma, adding that the FDA had invited Geron to give “a major presentation.”

A lot of it has to do with dig this buy canada levitra what they think about the treatment that they’re getting. It works to restore sexual desire by freeing up testosterone, thereby allowing you to have better sex drive and stamina sales online viagra levels. Because of to their compact measurement, it does not necessitate a wonderful deal of salt to respitecaresa.org online cialis have detrimental affects. 6. The cost of the medicine commander cialis is about $ 1.00 per pill. “The FDA is nervous. It’s under tremendous pressure. They can’t appear adversarial but they can’t seem to be rolling over for industry, either” said Richard Garr, CEO of Neuralstem Inc., which develops adult-stem-cell products. Mr. Garr said he is worried that if the hearings focus on unresolved safety problems in embryonic-stem-cell technology the FDA could decide to slow down the process of considering stem-cell therapies. “It’s my nightmare scenario,” he said.

The hearings could provide a stage for some companies to make a splash about new cell-based drugs in development or to prod the FDA on shifts in the way it judges safety standards for embryonic-stem-cell therapies. The FDA is reviewing other stem-cell-based technologies, but embryonic stem cells are prized because they can regenerate quickly and act like almost any other cell in the body.

“There is now enough of a critical mass to have this meeting,” said FDA spokeswoman Karen Riley.

Concerns remain that embryonic stem cells can trigger benign tumors called teratomas.

“There’s always an issue for the FDA with novel technologies” on how to evaluate safety, said Celia Witten, director of the agency’s office of cellular, tissue and gene therapy.

One of the most-critical problems the FDA must tackle is how to determine the length of time for a stem-cell trial in animals before proceeding to human testing, Dr. Witten said.

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Aastrom’s Stem Cells Knit Hard-to-Heal Bone Breaks

Aastrom’s Stem Cells Knit Hard-to-Heal Bone Breaks (Update1)

By Rob Waters

Oct. 18 (Bloomberg) — Aastrom Biosciences Inc. said its stem cell treatment repaired fractures in 91 percent of patients with previously hard-to-heal breaks in the long bones of their thighs, shins or arms.

The study tested stem cells developed by Aastrom by inserting them during surgery into the fracture sites of 33 patients with severe bone breaks that had previously failed to join from standard treatments. A year later, the fractures of 30 of the patients had healed, the Ann Arbor, Michigan-based company reported today at a medical meeting in Boston.

“We are treating patients that have not healed in the past and are unlikely to heal in the future with normal procedures,” said Elmar Burchardt, the company’s vice president of medical affairs, in a telephone interview. “It’s a completely new approach for bone treatment and tissue regeneration with the idea of restoring its original architecture.”

Aastrom, one of several U.S. companies working to bring stem cell-based treatments to market, has created a technique for expanding and purifying patients’ own stem cells as a therapy. The company is testing its approach in several orthopedic uses as well as in a disease that restricts blood circulation in limbs. It’s also developing treatments for patients with heart disease and spinal cord injuries.

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The company is furthest along in testing its cells to treat a rare condition called osteonecrosis that damages bone in the hips and other places because of a poor blood supply. The company is now recruiting 120 osteonecrosis patients for the final stage of testing normally required for regulatory approval. It could seek clearance from the U.S. Food and drug Administration as early as 2010, Burchardt said.

Aastrom rose 4 cents to $1.20 at 6:02 p.m. New York time in extended trading. The stock gained 2 cents to $1.16 at 4:20 p.m. in regular Nasdaq Stock Market composite trading.

The 30 bone-fracture patients who were deemed by the company to have healed all had bone scans that showed “multiple contact points” between pieces of bone that were formerly fragmented, Burchardt said. The patients’ limbs now “are fully weight- bearing and have full range of motion,” he said.

To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net .

 

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Aastrom Will Test Stem Cells in Patients With Diseased Limbs

Aastrom Will Test Stem Cells in Patients With Diseased Limbs
By Rob Waters
April 30 (Bloomberg) — Aastrom Biosciences Inc. will begin a clinical study using people’s own stem cells to improve the poor blood circulation that has damaged their legs, a condition known as critical limb ischemia.
U.S. regulators have given the company permission to begin trials, based on results from a small pilot study in Germany that suggested the treatment was safe, said Elmar Burchardt, vice president of medical affairs at the Ann Arbor, Michigan, company.
About 900,000 Americans suffer from limb ischemia, which can impair the body’s ability to heal wounds and leads to 100,000 amputations each year, according to the U.S. Centers for Disease Control and Prevention. The condition is the most serious form of peripheral artery disease, which occurs when blocked arteries impede the flow of blood to the legs. It affects about 10 million people in the U.S.
“These are critically ill patients,” said Burchardt, in a phone interview. “Their wounds are not closing and they have a very high risk of having to undergo an amputation.”
The trial will include 120 patients at 20 centers around the U.S. Doctors will take bone marrow cells from the patient’s hips and send them to Aastrom, which will process them to increase the number of stem cells while keeping them from turning into other cell types.
Bone marrow is one of the places in the body where so- called adult stem cells are found. These cells have the ability to turn into cartilage, bone and blood and are part of the body’s own system for repairing injury and disease.
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In half the patients, the amplified cells will then be injected at multiple points in their legs, above and below the knee. The other patients will go through the same procedure but won’t get real stem cells.
“The idea is you cover a large area with injections, stimulate vessel growth and improve blood flow in the limb,” Burchardt said.
Eight patients went through this procedure in the German study, Burchardt said. About half have passed the one-year mark, and all of those showed signs that their wounds were healing. None of the eight patients experienced any adverse effects, he said.
If successful, results from the larger U.S. study “may apply to all ischemic diseases,” said Anthony Comerota, director of the Jobst Vascular Center in Toledo, Ohio, in a statement e-mailed by Aastrom. He is the study’s lead investigator.
The study could thus help validate the idea of using stem cells to treat heart disease. The first results from the new study won’t be available until patients have been treated for a year.
To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net .
Last Updated: April 30, 2007 07:01 EDT

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Stem cells delay paralyzing disease

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Stem cells delay paralyzing disease
Mon Oct 16, 2006 3:08 PM ET

By Maggie Fox, Health and Science Editor

WASHINGTON (Reuters) – Human fetal stem cells can graft onto the spines of rats and delay some of the paralyzing symptoms of motor neuron disease, commonly known as Lou Gehrig’s disease, U.S. researchers reported on Monday.

The new cells were resistant to the disease, also known as amyotrophic lateral sclerosis or ALS, the researchers said.

A company associated with the researchers is incubating batches of the human cells, taken from an aborted fetus, and hopes to market them as a treatment for several sorts of paralyzing conditions.

“We were extremely surprised to see that the grafted stem cells were not negatively affected by the degenerating cells around them, as many feared introducing healthy cells into a diseased environment would only kill them,” said Dr. Vassilis Koliatsos of Johns Hopkins University, who helped lead the study.

The researchers, who published their findings in the journal Transplantation, used specially bred rats that always develop symptoms of ALS and die. Like people with the disease, they gradually become paralyzed until they suffocate when breathing muscles stop working.

There is no cure for ALS and the causes are not clear. But the Johns Hopkins team wanted to see if grafting new cells into the body might help preserve some muscle function.

They used cells taken from an 8-week-old fetus, which had been donated by the mother after an abortion. Stem cells are partially developed but can give rise to a variety of different tissues if put into the right environment.

The cells from the aborted fetus are not the same as embryonic stem cells, currently at the center of a political debate in the United States. Fetal stem cells are intermediate between embryonic stem cells and so-called adult stem cells.

 

They are somewhat more malleable than adult stem cells but not as plastic as embryonic stem cells.

In this case, the researchers took the cells from the developing spine. These cells are already destined to become nervous system tissue and do not elicit an immune rejection by the body, said Karl Johe, chairman and chief scientific officer of Neuralstem Inc. in Rockville, Maryland.

NO CURE

The researchers only transplanted cells into the lower spinal cords of the rats, in part because the animals are so tiny and the job is tricky, said Johe. Because the upper spinal cord controls the upper half of the body including breathing, there was no chance of curing the rats.

“They do develop symptoms and also they still die, but the onset is more slowly developing and the longevity is extended,” Johe said in a telephone interview.

They injected the human fetal stem cells into adult rats not yet showing symptoms and also killed some of the stem cells and injected them into other rats to act as a control.

On average, the rats treated with live stem cells started losing weight — one of the first symptoms of disease — after 59 days and they lived for 86 days. In contrast, the rats given the sham treatment started to lose weight at 52 days and only lived for 75 days.

While all the rats grew steadily weaker, the treated rats maintained their ability to crawl up a slope for much longer than untreated rats.

After the rats died the researchers examined their spines and saw that 70 percent of the transplanted cells had developed into nerve cells.

Johe said the company was growing and nurturing the cells and hoped to create many batches of purified cells that could be used for transplants for a range of patients with spinal cord diseases or injuries.

“If we see in a year … really significant effects (in rats) then I think we could be ready for a (human) clinical trial in another year after that,” Johe said.