Neuralstem News

• StemCells Accused by Neuralstem of Misusing Patents (Update2)

Bloomberg by Susan Decker and Rob Waters, October 31, 2006

StemCells Inc. was accused by Neuralstem Inc. of misusing patents in an effort to monopolize the use of stem-cell technology in research on damage to the nervous system.

Neuralstem, in papers filed yesterday in U.S. District Court in Greenbelt, Maryland, claimed StemCells also used ``sham litigation'' to control the market. The filing was in response to an infringement suit StemCells brought against Neuralstem in July.  Neuralstem has asked U.S. District Judge Alexander Williams Jr. to dismiss the case.

``StemCells' initiation of this lawsuit constitutes an intentional attempt to monopolize the relevant neural stem cell market, and a dangerous probability exists that StemCells will succeed in this scheme,'' Neuralstem said in the filing.

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StemCells, based in Palo Alto, California, said it owns the technology for the use of neural stem cells, derived from the brain and spinal cord, and Neuralstem lacks a license. Closely held Neuralstem, based in Rockville, Maryland, contends it uses a different method to replicate and use the stem cells.

Both companies use so-called adult stem cells derived from aborted fetuses. Unlike embryonic stem cells, which can morph into any type of body cell, adult stem cells can only develop into a few cell types, usually related to the organ where they originated. They help the body mend itself, migrating to sites of injury to replace or repair damaged tissue.

Fatal Disorder

StemCells is testing the use of neural stem cells to treat Batten disease, a rare and fatal disorder that causes loss of movement, sight and mental capacity. The company said it expects the first patient in a safety trial will receive the treatment later this year.

StemCells officials weren't available to comment, outside spokesman Andrew Law said.

Shares of StemCells rose 2 cents to $3.17 in Nasdaq Stock Market trading at 4 p.m. New York time. They have fallen 8.1 percent this year, valuing the company at $246.6 million.

Neuralstem is researching the use of the neural stem cells to recreate a type of neuron that controls lower-body movement.  The cells die and cause paralysis in about 5 percent of patients whose aortas are clamped during surgery, or about 1,000 patients a year, Neuralstem Chief Executive Officer Richard Garr said.

The aorta, the large artery that sends blood from the heart to the rest of the body, is clamped during certain chest surgeries to limit bleeding.

Earlier this month, researchers announced that the neural stem cells developed by Neuralstem and transplanted into the spinal cords of rats slowed the onset of a form of Lou Gehrig's disease, a condition that attacks the nerve circuits that control movement.

Going Public

Neuralstem claims that StemCells is trying to interfere with the company's plans to become a public company. Neuralstem denies infringing the StemCells patents and seeks a court ruling that they are invalid or not infringed.  Neuralstem says that even if it is infringing, any use is allowed because it is necessary to win FDA approval. Under U.S. law, a drugmaker can use another company's patented technology if the use is ``reasonably related'' to applications under FDA consideration.

Judge Williams yesterday limited the amount of information each side has to show the other until he rules on Neuralstem's request to dismiss the case. StemCells must respond to the request by Feb. 23, Armstrong ruled.

The case is StemCells Inc. v. Neuralstem Inc., 06cv1877, U.S. District Court for the District of Maryland.

--With reporting by Jeff St.Onge in Washington. Editor: Farr.

Story illustration: To read the original complaint, see:

{NSN J2ZBYZ3PWT1E }. To review the disputed patent through the U.S. Patent and Trademark Office's Web site, search for patent number 5,851,832; 6,103;530; 6,497,872; and 6,294,346 at http://patft.uspto.gov/netahtml/PTO/srchnum.htm. To contact the reporter on this story:

Susan Decker in Washington at (1) (202) 624-1941 or This email address is being protected from spambots. You need JavaScript enabled to view it. .

To contact the editor responsible for this story: Patrick Oster at (212) 617-4088 or This email address is being protected from spambots. You need JavaScript enabled to view it. .

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• Stem Cells Delay Paralyzing Disease

Reuters by Maggie Fox, October 16, 2006

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.

• Human Stem Cells Help Rats to Fend Off Lou Gehrig's Disease

Bloomberg by Rob Waters, October 15, 2006

Neural stem cells transplanted into the spinal cords of rats from a human fetus slowed onset of a form of Lou Gehrig's disease, a condition that attacks the nerve circuits that control movement.

Researchers placed the cells in rats genetically engineered to develop a form of the disease, also know as amyotrophic lateral sclerosis or ALS. The rodents with the cells were slower to show symptoms such as weight loss and diminished strength, and lived about 11 days longer over a 30-month life span.

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The finding suggests stem cells can be grafted into damaged nervous systems for a clinical benefit, contradicting the belief of many scientists. It may also eventually offer hope to about 5,600 people in the U.S. who are diagnosed yearly with ALS, which is almost always fatal.

``The dogma was that the spinal cord can not make neurons, or allow engrafted cells to become neurons,'' said Vassilis Koliatsos, the Johns Hopkins School of Medicine neurologist who led the study, in an Oct. 12 telephone interview. ``The assumption was also that because this is a toxic environment where motor neurons are dying, the cells would die.''

These assumptions ``are increasingly proven wrong'' by this research and other recent studies, he said. Koliatsos's study was published today in the journal Transplantation.

The transplanted cells, which developed into neurons, or nerve cells, formed connections to existing neurons that had been damaged by the disease and were able to convey information through electrical signals and deliver proteins to help nourish the sick cells, Koliatsos said.

Neuralstem Inc.

The researchers used a line of neural stem cells developed by Neuralstem Inc., a closely held biotechnology company based in Rockville, Maryland. The company developed the line from fetal tissue donated by a woman who underwent an elective abortion at 8 weeks.

The stem cells, taken from an area near the developing spinal cord of the fetus, have the theoretical ability to develop or differentiate into any of three cell types found in the nervous system. The cells were kept alive in culture and chemically manipulated to keep them from differentiating.

The researchers exposed the spinal cords of the rats and used a tiny micropipette to inject cells. Rats in one group were given about 400,000 living neural stem cells; another control group was injected with dead cells.

The rats that got the live cells began losing weight at about 59 days on average, a week later than the rats in the control group. When made to walk an uphill plank as a strength test, the cell-treated rats performed better over a longer period of time. They also lived to about 86 days, 11 days longer than the control rats.

70 Percent Developed

When the rats were examined after their deaths, the researchers found that more than 70 percent of the transplanted stem cells had developed into nerve cells, and that many grew endings that connected to other cells, allowing them to transfer nerve impulses that direct muscular action and movement.

``These cells became neurons and they also made connections to sick neurons,'' he said. ``If you make connections to sick neurons, you close the circuit, you give them information.''

The connections allowed needed proteins and growth factors produced by the new neurons to pass to the damaged cells. This may help solve a problem that has vexed researchers. When scientists have delivered these proteins and growth factors, also known as trophic factors, using drugs, they reached unwanted targets and caused side effects, Koliatsos said.

`Delivers the Goods'

``You use the stem cell as a very complex biological structure or machine that manufactures and sends these trophic factors where they ought to be given,'' he said. ``It delivers the goods right on target.''

In this experiment, stem cells were injected in the portion of the spinal cord that controls the lower body. The next step, which Koliatsos has already begun working on, is to deliver the cells to the part of the spinal cord that controls upper body motion, including chest wall expansion and breathing.

``We need to do that, see if it's well tolerated and see if we can extend their survival longer,'' Koliatsos said. After that, he said, he'll start thinking about how to study this type of treatment in people.

About 30,000 Americans have Lou Gehrig's disease, according to the ALS Association. The disease begins with weakness in the arms and legs, and progresses to paralysis as motor neurons are damaged.

The study was funded by the National Institutes of Health, the Muscular Dystrophy Association and the university's Robert Packard Center for ALS Research.

To contact the reporter on this story: Rob Waters in San Francisco at This email address is being protected from spambots. You need JavaScript enabled to view it. .

To contact the editor responsible for this story: Robert Simison at This email address is being protected from spambots. You need JavaScript enabled to view it. .

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• NeuralStem CEO, I.R. Garr Quoted in Baltimore Sun

August 04, 2006

In an article in the Baltimore Sun, it was announced that Osiris Therapeutics, Inc. is the third Maryland biotechnology company to go public this year.  The company raised about $38.5M.

According to the article by Tricia Bishop, "Neuralstem Inc. is another Maryland stem cell company hoping to take that route this year.

'Ultimately, we're going to need a lot of resources,' Chief Executive Officer I. Richard Garr said in an earlier interview. "There comes a point where you can only get those resources from a public market."

• StemCells Accuses Neuralstem of Infringing Stem-Cell Patents

Bloomberg by Susan Decker, July 25, 2006

July 25, 2006 (Bloomberg) – StemCells Inc., which uses stem cells to research treatments for damage to the nervous system, liver and pancreas, sued Neuralstem Inc. to stop the development of rival products. StemCells said it owns the basic technology for the use of neural stem cells, derived from the brain and spinal cord, and Neuralstem lacks a license, according to the lawsuit filed yesterday in Greenbelt, Maryland. The companies are the only ones with patented technology for the use of neural stem cells, Neuralstem Chief Executive Officer Richard Garr said. StemCells, based in Palo Alto, California, failed to persuade the U.S. Patent and Trademark Office to withdraw a Neuralstem patent.

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StemCells Inc., which uses stem cells to research treatments for damage to the nervous system, liver and pancreas, sued Neuralstem Inc. to stop the development of rival products.

StemCells said it owns the basic technology for the use of neural stem cells, derived from the brain and spinal cord, and Neuralstem lacks a license, according to the lawsuit filed yesterday in Greenbelt, Maryland.

The companies are the only ones with patented technology for the use of neural stem cells, Neuralstem Chief Executive Officer Richard Garr said. StemCells, based in Palo Alto, California, failed to persuade the U.S. Patent and Trademark Office to withdraw a Neuralstem patent.

"This is just a continuing story of them trying to crush the competition,'' Garr said in an interview. Neuralstem, based in Rockville, Maryland, will challenge the suit because its stem cells are more regionally specific than the ``generic'' StemCells technology, he said.

Stem cells can mature into myriad cells and tissues. Both companies use cells from fetal brain tissue donated by women who had abortions, miscarriages or stillbirths.

StemCells sued over four patents tied to the cell cultures grown in labs, ways to make them grow, and their use. The company is conducting studies on its first product, a therapy for infants with a rare and fatal disorder called Batten disease that causes loss of movement, sight and mental capacity.

StemCells seeks a court ruling that Neuralstem must stop infringing the patents, as well as cash compensation. Neuralstem has filed with the U.S. Securities and Exchange to become a public company.

The case is StemCells Inc. v. Neuralstem Inc., 06cv1877, U.S. District Court for the District of Maryland (Greenbelt).
To contact the reporter on this story: Susan Decker in Washington at This email address is being protected from spambots. You need JavaScript enabled to view it. .

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