• Attacking Lou Gehrig's Disease from all Angles

By Debra Kain, May 23, 2007

Attacking Lou Gehrig's Disease from all Angles: UC San Diego stem cell researcher will participate in major U of Michigan research effort.  The potential use of stem cells to treat the paralyzing disease amyotrophic lateral sclerosis (ALS), or Lou Gehrig's disease, will be the focus of a new research project at the University of California, San Diego (UCSD) School of Medicine in partnership with the University of Michigan.

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Twenty years ago, retail pioneer and philanthropist A. Alfred Taubman lost a good friend to ALS — an incurable, fatal disease.  The memory of watching New York Sen. Jacob Javits slowly succumb to the nerve-killing condition has motivated him to support ALS research with a $5 million gift to the University of Michigan. A major portion of the gift will support collaboration between U-M and UC San Diego scientist Martin Marsala, M.D., a stem cell researcher whose focus is protecting and repairing damaged spinal nerve cells.

Martin Marsala & Eva Feldman
Marsala, professor of anesthesiology at the UCSD School of Medicine, will collaborate with University of Michigan neurologist and scientist Eva Feldman, M.D., Ph.D., DeJong Professor of Neurology at U-M Medical School and director of their department’s ALS clinic.  She also heads the U-M Program for Neurology Research and Discovery.

The California Institute for Regenerative Medicine (CIRM) recently awarded Marsala a $2.4 million grant for his research utilizing stem cells to repair spinal cord injury.  He is an expert on grafting new cells into the spinal cord, and has studied the use of stem cells to treat spinal injuries caused by interruptions in blood flow. The use of this technique in ALS, which involves the death of the motor neurons that send signals to the muscles and control movement, could be a new frontier in treating the disease.

Marsala calls the gift a major boost to research.

“Mr. Taubman’s generous funding allows us to venture into exciting new territory with stem cells,” he said.  “It gives patients great hope that our new research with our Michigan colleagues will translate the promise of stem cell technology into the reality of therapy for ALS patients.”

Already, Marsala and Feldman have spent several weeks of collaborative research in Marsala’s UC San Diego School of Medicine laboratory, implanting human spinal stem cells into animal spinal cords.  The promising results of this study, which have not yet been published, form the basis for one prong of the attack on ALS that will be supported by Taubman’s generous gift.  If additional laboratory work proves successful, a clinical trial in ALS patients could begin within five years.

The University of Michigan ALS project will also study genetic tools to keep nerve cells from dying, and new ways of delivering promising drugs and genes directly into nerve cells.

"It's hard to imagine a more devastating disease than ALS," says Taubman, "Dr. Feldman and her team are doing miraculous work, and it's important that they have the resources to build on their momentum. I'm not a doctor or a scientist, but I am an optimist who believes in the extraordinary possibilities of modern medicine. This is important work that must continue."

Taubman’s gift contributes to the $2.5 billion Michigan Difference campaign at the University of Michigan, and also to the $1 billion Campaign for UCSD fundraising effort at UC San Diego.

Background information on Amyotrophic Lateral Sclerosis or Lou Gehrig’s disease:

Called a neurodegenerative disease because it causes nerve cells to weaken and die, ALS attacks a specific kind of nerve cell called a motor neuron – the type of cell that connects muscles to the spinal cord and brain, and transmits signals that enable us to move.

As motor neurons in the upper and lower parts of the body begin to be attacked, patients may experience painless weakness in their hands, feet, arms or legs. They may also begin to have trouble walking, speaking or swallowing. Over time, the degeneration continues – robbing each patient of the ability to move, speak and function on his or her own, and ultimately killing each patient within months or years.

ALS has its roots in genetic mutations, but many have not yet been discovered. A small minority of ALS cases are inherited by members of families affected by gene mutations. But the vast majority of the approximately 30,000 Americans who currently have the disease have a spontaneous form that can strike anyone, anywhere. Treatments have improved in recent years, but ALS still challenges doctors and scientists as one of the most baffling and tragic diseases. Only through research such as that being performed at U-M and UCSD will new options arise.

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Media Contact: Debra Kain, 619-543-6163,    This email address is being protected from spambots. You need JavaScript enabled to view it.

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• StemCells Agrees to Stay in Patent Suit

By Adam Schreck June 28, 2007

StemCells Agrees to Stay in Lawsuit Against Neuralstem Over Disputed Patents

PALO ALTO, Calif. (AP) -- Biotechnology company StemCells Inc. said Thursday it has agreed to a stay in its patent-dispute lawsuit against Neuralstem Inc. while the U.S. Patent and Trademark Office re-examines the patents in question.

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StemCells' lawsuit alleges that stem-cell based products and other services being developed by Neuralstem infringe on four of its patents.

"We are confident that all of these patents will emerge from this process substantively unchanged," Martin McGlynn, president and chief executive officer of StemCells, said in a statement. "We firmly believe that in time Neuralstem will be found by the courts to be infringing our patents."

StemCells said the stay was made on mutually acceptable terms. However, the company said the move "is a procedural tactic often used by defendants to delay a trial."
Neuralstem CEO Richard Garr disputed that characterization.

"If this is just a delay tactic, why did they agree to it?" Garr said in an interview. "There is a very serious question about whether these patents are any good. To call it a delay tactic is absurd."

Rockville, Md.-based Neuralstem said its own patents related to human neural stem-cell technology are not being challenged in the patent review. The company said the motion also stays its counterclaims against StemCells.

StemCells said that regardless of the outcome, the review should have "no material effect on its patent portfolio."

Shares of StemCells were unchanged at $2.36 in midday trading. Neuralstem's shares gained 5 cents to $2.90 on the Over the Counter Bulletin Board.

Questions or comments about this story should be directed to reporter Adam Schreck at 212-621-7190.

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• Neuralstem Reports Spinal Cord Damage Results

May 30, 2007

The Rockville-based company, founded by a former National Institutes of Health scientist, reported in the online journal Neuroscience that three rats paralyzed by a specific spinal cord injury returned to near normal ambulatory function six weeks after having stems cells grafted to their spinal cords. Three others showed significant improvement after two months.

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It also says in all the grafted animals, the majority of the transplanted stem cells survived and became mature neurons.

The rats had Ischemic Spastic Paraplegia, an untreatable form of spinal cord damage that causes permanent paralysis, a potential side effect from surgery in humans to repair aortic aneurysms.

Neuralstem (OTC BB: NRLS), which went public in December, plans to file for regulatory approval to begin human trials with paraplegic patients sometime this year. Its patented technology allows for the production of neural stem cells of the human brain and spinal cord in large quantities.

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• MORNING NOTES, Michael A. Berry, Ph.D.

By Michael A. Berry, Ph.D., February 16, 2007

We’ve had a few days of Fed Chief Bernanke’s testimony in front of the “new” Congress for the semi-annual report. By all reports the House Financial Services Committee has been more than accommodating to him. Still a confusing inflation theme seeps forth. Dr. Bernanke said, “We’ve seen some very strong consumer spending numbers and we’ve seen some strong income growth, which suggests that the economy may be stronger than we think … in order for this expansion to continue in a sustainable way, inflation needs to be controlled,”

In Wednesday’s testimony he intimated that inflation was under control. But the coop de grace came from Congressman Barney Frank. The fine Congressman from Massachusetts asked the Fed Chief why he was worried more about inflation than growth.

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“Why not say we might raise rates or we might cut rates?”

This was a very subtle question. It goes directly to the heart of the Fed’s main problem. Dr. Bernanke actually wants Congress to agree to an inflation targeting strategy (an agreed upon positive rate of inflation). But this is inconsistent with the Bernanke testimony and Frank has understood this well. The two disagreed on labor as well. Dr. B suggesting that jobs were begging for American workers and the fine Congressman noting that the Bush policy of globalization was “pinching” American workers. The Fed believes that unemployment can decline further without increasing inflation. At the same time capacity utilization fell – a sign of economic weakening.

Hershey announced a layoff of 1,800 workers and Chrysler said it would layoff 13,000 workers this past week. Next, of course, was the announcement that growth would be revised down from 3.5% to 2.0%

These revisions should not surprise anyone. If you torture the data enough they will tell you anything you would like to hear.

Dr. B had no answer to the evident conundrum of why the Fed is presently biased toward tightening when the evidence is clearly moot. And so it continues in the FOMC – the razor’s edge.

At the same time the Fed Chief noted that lending guidelines would be strengthened. His concern about the vitality (survivability?) of the sub prime lending industry was also on parade. In spite of the positive housing spin from our leaders, it was evident that the Fed believes that we are not remotely close to a touch down in the housing debacle.

Even though the Fed maintains a tough “face” on inflation, there is quite likely a massive liquidity program in our future. Seek gold and silver dear D.I., gold and silver. The Bond market has fallen on all this news. It just does not see the inflation concern. Gold, on the other hand? Use your own judgment. Gold is telling an unequivocal tale. It is now at an all time high when priced in Japanese Yen. It is headed there in dollars as well.

2. NEURALSTEM

The science keeps on coming at Neuralstem. The company’s shares have only been trading since late December on the OTC BB but they seem to be making a base as investors sort out the potential of the company.

On February 13 the company announced that 37 rats with damaged spines had been transplanted with the company’s stem cells. After six months, researchers found that the grafted cells had increased by a factor of 3- to 4- fold. In addition they had differentiated into a significant population of neurons; and migrated to both gray and white matter, depending upon the original transplantation site. The connection between cholinergic and GABAergic neurons is a necessary part of healthy motor function. From this, researchers concluded that these neural stem cells could be grafted into rat spinal cords under a variety of injury conditions and robustly MORNING NOTES 4 OF 5 2/16/2007 differentiate into neurons that go on to form synaptic contacts with the neuronal circuitry of the host.

The study that utilized NRLS’s cells was conducted at The Johns Hopkins Medical Institutions. Out of these results came a peer reviewed paper that concluded that that the restoration of spinal cord circuitry may be more realistic than previously thought.

Dr. Karl Johe, Scientific Founder and Chairman of Neuralstem and a coauthor of the study, said, “The spinal cord has previously been considered inhospitable for neural stem cell transplants … they either didn’t survive well or didn’t make contact with the surrounding tissue. However, the results here disprove that notion. The high quality of neuronal differentiation and synaptic contact was consistent across different kinds of spinal cord injuries. When combined with our earlier spinal cord work in rats with ALS (Lou Gehrig’s disease), we now believe that the spinal cord is an effective site for therapeutic stem cell intervention.”

Dr. Vassilis Koliatsos, of The Johns Hopkins Medical Institutions, the study’s lead investigator, commented, “Never before have we seen such a massive differentiation of stem cells into neurons in the spinal cord … This turns on its head the dogma that the spinal cord isn’t an effective environment for turning stem cells into neurons. Additionally, a significant number of these neurons went on to engage in synaptic relationships with the host neurons. To what extent these contacts are functional synapses or signify structural integration into the host circuitry must be ascertained with additional studies.”

Neuralstem CEO, Richard Garr. Noted “We believe, as this study demonstrates, that our technology answers many of the issues that have held the field back, and makes it possible to build a stem cell company around a true product focus. We expect to initiate human clinical trials to treat Ischemic Spastic Paraplegia (ISP) with our cells in 2007,”

The material herein is for informational purposes only and is not intended to and does not constitute the rendering of investment advice or the solicitation of an offer to buy securities. The foregoing discussion contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (The Act). In particular when used in the preceding discussion the words “plan,” confident that, believe, scheduled, expect, or intend to, and similar conditional expressions are intended to identify forward-looking statements subject to the safe harbor created by the ACT. Such statements are subject to certain risks and uncertainties and actual results could differ materially from those expressed in any of the forward looking statements. Such risks and uncertainties include, but are not limited to future events and financial performance of the company which are inherently uncertain and actual events and / or results may differ materially. In addition Dr. Berry may review investments that are not registered in the U.S. Dr. Berry has been awarded 10,000 stock options exercisable at $7.50 from Senesco Technologies, 150,000 options which strike at $2.80 from Birch Mountain and a monthly retainer and 150,000 options from Ivory Energy and a monthly retainer fee for Corporate Finance consulting services. He is a paid consultant to Derek Oil and Gas and has been awarded 100,000 options exercisable at C$.47. Dr. Berry is a paid consultant to Oil Sands Quest for which he receives a monthly cash payment and has been awarded 400,000 options exercisable at C$2.00. He is a paid consultant to Kenrich Eskay for which he receives a monthly payment and 300,000 stock options exercisable at $1 and $1.75 respectively. He is a paid consultant to Energy Metals for which he receives a monthly payment of $2,500 and has been awarded 50,000 options that strike at $5.72. He owns shares and / or options in Goldcorp, Senesco Technologies, Birch Mountain Resources, DataMeg, Immtech International, Horseshoe Gold, Midway Gold, Derek Oil and Gas, Terraco Gold, Stealth Ventures, Kenrich-Eskay Gold, Galway Resources, Neuralstem and Quaterra Resources. He has been awarded 250,000 options on Terraco Gold exercisable at C$.50 for 5 years, for services as a financial advisor. He has also been retained as a paid advisor by Dejour, Grand Portage and Polymet. In his role as advisor he has been awarded 75,000 options from Polymet which strike at $1.76. We cannot attest to nor certify the correctness of any information in this note. Please consult your financial advisor and perform your own due diligence before considering any companies mentioned in this informational bulletin.

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• MORNING NOTES, Michael A. Berry, Ph.D.

By Michael A. Berry, Ph.D., January 12, 2007

Neuralstem (NRLS OTC BB), a company I have classified as a discovery company, announced that it has executed an exclusive license of its proprietary stem cell line to Biomedical Research Models, Inc. for the development of Neuralstem compounds to treat the cognitive and neurological impacts of diabetes. The license covers a library of Neuralstem patent-pending compounds, discovered using Neuralstem's patented human neural stem cells.

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The company said that the compounds, when orally administered,have been shown in adult mice to recruit and stimulate the body's own stem cells to form new neurons in the brain, and may be useful in healing and protecting injured brain areas. Biomedical Research Models, Inc., is focused on developing novel drug therapies for the treatment of diabetes. Neuralstem also recently received a $500,000 grant from the National Institute of Health to study compounds to treat depression.

It is very early in the Discovery cycle for investors in NRLS. However it appears that the company has a platform that produces regionally specific, physiologically relevant human nerve cells in large quantities. The company retains the rights to all indications except for the diabetes.

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