• Neuralstem CEO, Richard Garr, featured in CNNmoney.com

CNNMoney, April 09, 2008

NEW YORK (CNNMoney.com) -- The Food and Drug Administration looks like it's bowing to the inevitable this week and drawing the blueprint for the first-ever human experiments with human embryonic stem cells.

FDA advisors meet Thursday and Friday to begin to design how these embryonic stem cell tests will be conducted. It's an important regulatory step that could lead to human testing as early as this year. So far, biotechs have tested their spinal-cord drugs in animals, not people.

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"[The FDA meeting] is the first step towards clinical trials," said Laurie Zoloth, professor of medical humanities and bioethics at Northwestern University. "It's an important moment. And it's only the very beginning."

Human embryos are prized by medical researchers because of their fast and malleable regenerative properties. In theory, they could be used to heal severed spines, as well as damaged or diseased brains, hearts and other organs.

But their use is one of the most controversial issues in medical research, a controversy that centers on whether embryonic cell groupings, called blastocysts, are considered human life.

Dave Prentice, senior fellow for life sciences at the Christian organization Family Research Council, opposes the use of human embryos in research. "You shouldn't be destroying human embryos at the earlier stage of human life to harvest cells," said Prentice, who has a PhD. in biochemistry from the University of Kansas.

Other stem cell options are available, he said, such as harvesting them from umbilical cord blood or adult tissue, or "reprogramming" adult cells to behave like stem cells, as demonstrated in recently-released but early-stage studies.

Zoloth said she supports stem cell research because "the human embryo does not have the moral status of a dying child." Like other supporters, she pointed to the vast potential - though still unproven - of this science in healing traumatic injuries and degenerative diseases.

"I strongly support learning as much as we possibly can about human embryonic stem cells, as well as learning about other types of regenerative medicines," she said. "The fact that science could develop ways of healing very tragic human fates is an extraordinary capacity that we have been given by God. For people who aren't religious, you might say that we stand in a remarkable moment in human history."

The FDA seems to be more concerned with the stem cells' possible side effect of producing tumors. Because of the "potential risks" of human embryonic stem cell products, data showing a drug's effectiveness "may need to be particularly strong," the document said.

An administration spokesman would not comment further than the released document.

"The FDA needs to feel comfortable that the cells we use for our cell products will not cause teratomas," said Alan Lewis, chief executive of privately-held biotech Novocell, which hopes to begin human stem cell testing within three years for a possible diabetes treatment.

Lewis described the teratomas as non-malignant but unwanted pieces of muscle, hair or other matter that form as an offshoot of embryonic stem cells, which replicate quickly and can morph into different types of tissues, such as the liver or pancreas.

Geron (GERN) could be the first company to conduct experiments in humans with drugs made from human embryonic stem cells. The biotech is developing a treatment to repair spinal cord injuries. Geron has already filed an application to the FDA to begin human testing, according to analysts. But the biotech refused to confirm this and would not discuss the upcoming meeting.

So far, Geron's animal experiments have been tumor-free, said UBS analyst Graig Suvannavejh, who doesn't expect the company to run into problems with the FDA.

"For Geron, the best possible outcome overall is for [the] FDA to be peachy with everything they've done so far," said Suvannavejh in an email to CNNMoney.com. He believes Geron could begin human testing by mid-2008.

Steve Brozak, analyst for WBB Securities, emphasized that tumor-safety is imperative, and there is little room for failure in the current environment.

"It is one of the things that can be a problem if the science is not understood completely," he said. Geron needs "to make sure that the critics of the field don't have room to assail them with."

Advanced Cell Technology is using embryonic stem cells to develop a treatment for vision loss. Chief scientific officer Robert Lanza said his company plans to file an application for human testing to the FDA within months. He said the company has found a way to "differentiate" stem cells to reduce the possibility of tumor formation.

Neuralstem (CUR) works with stem cells derived from a donated human fetus, rather than embryonic stem cells. CEO Richard Garr said his company is developing a treatment for Lou Gehrig's disease, which degrades spinal cord nerve cells. He intends to file an application for human testing to the FDA in September or October.

Garr said that his company's pig tests have been tumor-free, and he hopes the FDA panelists focus on the science of stem cells, not the controversy, in designing requirements for clinical trials.

"What we hope to come out of this meeting is rationality," said Garr. "[We] hope that this isn't just something that a stem cell-unfriendly administration is trying put in place before they leave."

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• Microsoft Money contributing writer Michael Brush recommends Neuralstem for model portfolio

MSN Money by Michael Brush

If holiday shopping has blown your budget, here's some relief: Wall Street is offering bargains.

The stocks of many small yet promising companies have been hammered as nervous investors have shifted funds to the perceived safety of big businesses with proven track records.

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Here's the upshot: There's a fresh crop of stocks under $5 a share that could double in a year as investors come to their senses and realize the subprime-mortgage debacle won't bring economic Armageddon.

My five favorite stocks selling for less than the price of a Big Mac meal are stem-cell-research company Neuralstem (CUR, news, msgs), flat-panel-TV designer Syntax-Brillian (BRLC, news, msgs) and energy companies Teton Energy (TEC, news, msgs), International Royalty (ROY, news, msgs) and Abraxas Petroleum (ABP, news, msgs).

These stocks may see a bounce soon because of the January effect -- a rebound once the pressure of year-end tax-loss selling abates. But the bigger gains will come after some key changes in investor psychology play out.

"This is a flight-to-quality market, so anything perceived as risky has had a really hard time making headway," observes Eric Barden, a co-portfolio manager of the Texas Capital Value and Growth Fund. "But when this turns, it is going to turn really fast."

When is the turnaround coming?

Barden thinks it could be six months before investors develop an appetite for riskier small-cap stocks.

But I think he may be in for a surprise, and our under-$5 stocks could bounce back sooner than that. Here are four reasons why, thanks to James Paulsen, an economist and market strategist with Wells Capital Management:

• We've been waiting at least six months for the subprime disaster and housing weakness to bring down the economy. So far, they haven't. Employment and wage growth are hanging in there. Consumer spending was solid in November. Foreign demand for the goods we make is healthy. At some point, investors will realize the much-feared economic disaster ain't gonna happen -- and they'll develop a taste for riskier areas of the markets again, such as stocks selling for less than $5. The underlying conditions are still in place for decent economic growth: falling interest rates, government deficit spending, a weaker dollar and a continued expansion in the money supply.

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  Fears about shortages of liquidity -- the availability of money -- are overblown. Just look at the record levels of personal net worth in this country, the solid corporate balance sheets, currency reserves held by central banks and the amount of investment cash in the sovereign funds of foreign governments. "It's a preponderance of fear that is keeping liquidity in the closet, not a shortage of liquidity," Paulsen says. "If someone says things are OK, then watch the liquidity come out." Wait for signs that subprime-related write-offs are easing or for signs of continued economic strength to calm jitters. Again, a change in psychology will benefit the least liquid stocks the most, including our under-$5 stocks.

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  The weaker dollar helps small-cap stocks as much as big companies, if not more, because the cheap dollar attracts foreign buyers to our shores. Large-cap companies already have an overseas presence.

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  Historically, small-cap stocks do well when there is inflation, which is making a comeback.

So now, here's a closer look at five stocks trading for less than $5 that should benefit from these trends, as well as company-specific developments. To find these stocks, I looked for companies where insiders are buying the most, and I consulted with investors with good records who specialize in this part of the market.

Hope for paraplegics?

Researchers working with the tiny biotech company Neuralstem have discovered that if you implant the right human stem cells into the spines of paralyzed rats, the cells take over and regenerate in a way that allow the rats to walk again. This stunning breakthrough shows the promise of a controversial area of medicine known as stem-cell research.

But would this work in humans? The world is about to find out. By March, Neuralstem may begin testing the same science on humans in a study at the University of Pennsylvania. As early as three to six months later, it could start to see results. If this process, known as regenerative medicine, or cell therapy, shows promise in the study, I'd expect nice gains in this under-followed stock, which recently traded for $2.85 a share.

The Pennsylvania study will test the use of stem cells to treat a kind of paralysis called ischemic paraplegia. This occurs when people have a hemorrhage in the spine, typically because doctors had to clamp the aorta, the main artery from the heart, when treating another problem. Strictly speaking, this is just a "feasibility and safety" study.

"But these will be real patients getting the real thing from the beginning, so we expect to see if we have impact," says Neuralstem Chief Executive Richard Garr.

Later next year, Neuralstem will likely begin testing cell therapy on patients with Lou Gehrig's disease or traumatic spinal cord injuries. The technique might also be used to treat other central-nervous-system disorders, such as Parkinson's and Alzheimer's diseases, and even depression.

Neuralstem is a player in this space because it owns technology that allows doctors to reproduce huge amounts of stem cells and to shut off the reproduction process when enough have been made.

Flat-panel play

If you've been shopping for a flat-panel TV this holiday season, chances are your eyes have gazed on the Olevia brand of Syntax-Brillian, a tiny company based in Arizona that outsources manufacturing to Asia.

In the past four months the company has offered shareholders as much unwelcome drama as the flesh-eating zombies tormenting Will Smith in a futuristic Manhattan in the movie "I Am Legend."

Syntax-Brillian stock has tumbled 60% since early September to recently trade at $2.45 a share. But insiders clearly think investors are overreacting to a couple of pieces of bad news. In the past month, they've snapped up $2.2 million worth of stock.

Syntax-Brillian designs and sells high-definition televisions that use liquid-crystal-display (LCD) technology. It also owns camera maker Vivitar, which it bought in November 2006.

In September, Syntax-Brillian stock got hammered when it said the credit crunch was squeezing Asian suppliers and hurting production. Then it announced a move to a royalty model for sales in China, meaning it would take a small cut of sales by licensing its brand instead of managing production itself. There was also a management shakeup that saw the finance chief exit -- rarely a reassuring event.

Investors are understandably unhappy with all of this, but consumers love Syntax-Brillian's flat-panel TVs, and that's what counts for me. Sales were up 54% in the third quarter. The company is in the sweet spot, selling midrange LCD TVs going for $1,000 or more.

"That is where the demand is right now, and these guys are really well-positioned there," says Mark Mowrey, a tech stock analyst who writes the TechValue Report. He thinks the stock will eventually trade up to $7 a share.

3 natural-resource plays

I believe energy and natural resources will continue to be hot sectors, so I'm including three plays from these areas in my under-$5 picks. The first is Teton Energy, a really small (market cap: $74 million) producer of natural gas in the Rockies. Because pipeline constraints make it hard to transport natural gas out of the Rockies, natural gas is cheaper there. This has hurt producers in the Rockies, but that may begin to change starting next year, Teton chief Karl Arleth explains.

The reason: Kinder Morgan Energy Partners (KMP, news, msgs) and ConocoPhillips (COP, news, msgs) are putting in a pipeline that should increase "export" capacity out of the region by 29% over the next two years.

Meanwhile, Teton should double production capacity next year, and it has enough financial strength to do that without issuing new stock, Arleth says. All of this may explain why insiders have purchased $691,000 worth of stock in the past month, according to InsiderScore.com.

International Royalty generates income by purchasing the rights to future royalty payments from mines producing metals such as copper, nickel and gold. It buys the royalty streams from mining companies that need to generate cash or from owners of mineral rights looking to cash out.

"The company is mainly tied to copper and nickel prices, which have gotten hammered in past three months," says Joe Dancy of LSGI Advisors, an investment company. So International Royalty shares have suffered, trading below $5 recently from above $7 in October.

But Dancy thinks copper and nickel prices will improve because of continuing strong demand from China, India and other emerging economies. He agrees that gold prices should go up because of a weakening dollar. So he thinks International Royalty is a buy below $5.

He's worth listening to because his LSGI Advisors has produced annualized returns of 23.7% a year over the past eight years by investing in small-cap stocks.

In early November, Abraxas Petroleum announced production and sales declines for the third quarter, and its stock has fallen 26% to $3.40. But the company says it can get back into growth mode through exploration and more-efficient production at its properties in Texas and Wyoming. It's also buying properties through a subsidiary called Abraxas Energy Partners, which the company hopes to spin out at some point. Insiders are putting their own money behind the plan. They've purchased $1.5 million worth of stock in the past six months, at prices below $4, a convincing vote of confidence.

Some words of caution

As microcap companies with narrow business plans, these five plays under $5 carry greater-than-average risk that something big could go wrong and derail the stocks. The stocks also have limited liquidity, or average daily volume, which means volatility; bad news could have a big downside.

The limited liquidity can also hurt you in another way: If any of these stocks are up more than 10% because of buying interest generated by this column, I strongly advise you to wait a few days and buy when the interest cools off, so you don't end up paying too much.

I like the prospects for all of these, and I believe overly negative sentiment toward small-cap stocks will reverse, so I'm putting all five of these in my model stock portfolio in MSN Money's Expert Picks section.

At the time of publication, Michael Brush owned shares of Neuralstem.

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• Rubicon Global Research Buy-Side Investment Analysis

October 9, 2007

Investment Thesis/ Summary Conclusion:

Neuralstem, Inc. is a biopharmaceutical company with a robust and diverse development pipeline derived from its novel and patent protected human neural stem cell (hNSC) technology. The Company's research and development efforts target the treatment of debilitating central nervous system (CNS) disorders for which no effective treatments exists.

 

• 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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