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Stem cell trial seeks longer lives for victims of deadly ALS

 

Researchers at Emory University in the United States are hoping to extend the lives of patients diagnosed with the deadly neuro-degenerative disease, Amyotrophic lateral sclerosis (ALS). ALS kills by destroying a patient’s nervous system but in clinical trials, the scientists say injections of neural stem cells show promise in slowing the disease’s progress. Ben Gruber reports.
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Neuralstem’s $19.6M offering takes ALS bid through phase II

By Randy Osborne, Staff Writer
Neuralstem Inc.’s $19.65 million from a stock offering will help
advance the lead compound NSI-566 in amyotrophic lateral sclerosis
(ALS), which is “about halfway through” a Phase II trial, said CEO
Richard Garr.
Rockville, Md.-based Neuralstem is selling about 6.7 million shares
at $2.91 each in the offering. Each investor also gets a warrant to
buy half the number of shares purchased. Warrants bear an exercise
price of $3.64, and can be exercised for fi ve years.
Shares (NASDAQ:CUR) closed Friday at $2.97, down 19 cents.
Expected to close next week, the offering’s proceeds will get
Neuralstem through Phase II in the ALS effort with spinal cordderived
stem cells, as well as the small-molecule program, where
the company has “just completed a Phase Ib trial in major depressive
disorder,” Garr told BioWorld Today. “We’re looking at the data now,
and anticipate sometime in this quarter fi ling for a Phase II.”
Stem cell trials are neither much more expensive nor much cheaper
than tests of other therapies. “That’s always in the eye of the
beholder, isn’t it?” Garr noted. “Drug trials, especially for depression,
are expensive. Everybody knows what the FDA expects and what the
parameters are. It doesn’t cost us any more or any less than anybody
else.”
Cell therapy as a whole is “fairly expensive,” he said. “In terms of the
dollars per patient, it’s very expensive, but in terms of the numbers
of patients, because it’s fairly small, the overall cost is manageable.”
The Phase II trial in ALS got funding help from the National Institutes
of Health and from the ALS Association, he said.
“We have to wait six months after the last surgery for the trial to
end,” Garr said. “Sometime near the end of this calendar year, the
Phase II [in ALS] should be over completely.”
Neuralstem’s approach represents the world’s fi rst intraspinal
injections of stem cells. “This is a targeted surgery at various
segments of the spinal cord, and the cells actually go into the
motor neuron pools in those segments and synaptically integrate,”
Garr said. “There have been, in the past, people who have tried to
put what you would think of as adult stem cells – all kinds of bone
marrow and blood stem cells and things like that – into the spinalfl
uid cavity,” though such experiments took place “mostly in Mexico
and in Germany and other places,” as well as China, he said.
“Our approach is unique, actually rebuilding the circuitry,”
Garr said. “These cells don’t fl oat up and down in the spinal
fl uid, and they don’t migrate to the spinal cord. They’re going
in and creating new circuitry inside very specifi c segments
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muscles that control breathing and swallowing give way, so
do the patients, not long afterward.
HUMAN DATA FUELING STOCK
Neuralstem also has been given clearance by the FDA to
start a spinal cord injury trial in complete paralysis patients,
using the same technology.
“Geron, of course, famously, had an approval from the FDA
[for trials] with their oligodendrocyte progenitor [GRNOPC-1]
cells to try to treat spinal cord injury,” Garr said. “I believe
they may have actually transplanted two or three patients
before they pulled the plug.”
Menlo Park, Calif.-based Geron last April disclosed in an SEC
fi ling that the assets related to the program were taken over
by Asterias Biotherapeutics Inc., a subsidiary of regenerative
medicine specialist Biotime Inc., of Alameda, Calif. The deal
involved transfers of common stock and warrants, along
with patents, regulatory fi lings and investigational new drug
applications fi led with the FDA for Geron’s Phase I safety
study with the cells. (See BioWorld Today, Jan. 26, 2009, Jan.
27, 2009, and April 5, 2013.)
“The mechanism of action by the cells, even though it’s the
same cells, is a little different [in spinal cord injury, where]
the idea is literally to build new circuitry to bridge the gap,
to bring function back to paralyzed patients,” Garr said. “In
ALS, even though patients lose their ability to walk, it’s not
because there’s a break in the signal coming down the spinal
cord from the brain. It’s because the muscles have atrophied
and died. Our main goal here is to improve the quality of life
and extension of life for these patients, is to keep them off
breathing machines for as long as possible.”
Neuralstem’s shares have been on the climb for about a
year. ”We don’t really talk about the stock that much,”
Garr said, because market changes are too hard to explain,
in most cases. “The clear answer is, there’s no substitute
for human data,” and interim data have been showing up in
presentations.
“A publication is coming out, we expect, on the Phase I trial [in
ALS],” he said. “Some of the patients went public, and it was
in Newsweek. It was pretty clear, just from a lay perspective,
they were seeing a defi nite benefi t to a number of patients, and
long term, not just marginal but signifi cant, quantitative actual
improvement that no one has seen before, and that has lasted
a very long time.”

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Beach Mining in Monterey Bay Causes a Dustup

Beach Mining in Monterey Bay Causes a Dustup

Officials in California Weigh Limits on a Decades-Old Facility That Dredges Sand

http://online.wsj.com/news/article_email/SB10001424052702304202204579254312563952176-lMyQjAxMTAzMDEwNTExNDUyWj

By

Jim Carlton

Updated Dec. 15, 2013 6:42 p.m. ET

California’s Monterey Bay is one of the most protected coastlines in the U.S., but sand mining operations are coming under increased scrutiny as opponents say they are contributing to heavy shoreline erosion. WSJ’s Jim Carlton reports.

MARINA, Calif.—California’s Monterey Bay boasts one of the nation’s most protected coastlines, situated within a federal sanctuary that imposes bans on everything from Jet Skis to offshore drilling.

Yet most days, hundreds of tons of sand are harvested from one of its most picturesque beaches, in a mining operation now coming under increased state and local scrutiny.

 

A dredge used by Cemex at a private beach in California’s Monterey Bay mines sand from a pond that contains sand-filled water carried by waves. James Tensuan for The Wall Street Journal

About 159,000 tons of sand annually are being dredged from pools just beyond the beach by an arm of Mexican cement giant Cemex SA B, the company says. Because that is also roughly the amount of sand that marine researchers say the local beach needs to replenish itself each year, officials here say the mine has greatly exacerbated an erosion problem like those ravaging shorelines world-wide.

“I don’t think you would see many people shedding a tear to see that go away,” said Jason Burnett, mayor of nearby Carmel-by-the-Sea and vice president of the Monterey Peninsula Regional Water Authority. “It’s probably the most invasive coastal impact we have.”

Spurred by local complaints, the California Coastal Commission is investigating whether the facility—which operates on privately owned property—should be sharply restricted. Mr. Burnett has gone a step further, suggesting Cemex consider selling the mining operation “rather than engage in this potential fight with the community.”

Cemex officials have expressed no inclination to sell, and they say there is no evidence that its mine, which has operated for decades under various owners, is contributing to the beach’s erosion. “We feel it is unsubstantiated,” said Sara Engdahl, spokeswoman for Cemex’s U.S. operations. The mine, which sells its sand primarily in California for uses including construction and water filtration, is one of 50 that Cemex operates across the U.S. but is the only one that harvests beach sand.
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The Monterey Bay debate comes as communities globally are struggling with ways to slow beach erosion, which threatens coastal infrastructure as well as tourism at a time when rising sea levels are likely to result in the loss of more shoreline, said Cheryl Hapke, a research geologist with the U.S. Geological Survey.

In California, beach sand historically has been partly replenished as part of a natural cycle: washed offshore during winter storms, it is returned to the beach later by waves, said Gary Griggs, director of the Institute of Marine Sciences at the University of California, Santa Cruz.

But that cycle has been interrupted over the past century on Marina’s dune-covered coastline just north of Monterey by a succession of sand mines, he said.

By 1988, five mines that had operated on public beaches here were ordered shut down by the U.S. Army Corps of Engineers because of erosion concerns. That left just the 100-acre facility on private land now owned by Cemex, Mr. Griggs said.

 

A sample of coarse sand from the beach in Marina, Calif. James Tensuan for The Wall Street Journal

Few other sand mines operate along coastlines in the U.S. Some operating in inland U.S. locations, such as Minnesota, have drawn fire from nearby residents for concerns such as noise, traffic and water pollution. The mining of sand has been boosted in recent years because of its use in hydraulic-fracturing operations by oil companies.

In 2008, a study conducted for the Association of Monterey Bay Area Governments by an environmental hydrology firm concluded the Cemex mine was responsible for at least half the erosion rate of adjoining Marina State Beach. At 5 feet a year lost to the sea, the beach has one of the highest coastal-erosion rates in California, according to USGS estimates. The statewide average is about 0.7 feet annually, Ms. Hapke said.

In 2009, the Monterey Dunes Coalition, a consortium of environmentalists, cited that study in asking the Coastal Commission to investigate whether the mine has violated state regulations by more than doubling the production level believed to have been authorized by a previous state agency 40 years ago.

“My objective is to get some leverage over them,” said Ed Thornton, professor emeritus of oceanography at the Naval Postgraduate School in Monterey, and president of the coalition.

The Coastal Commission, which expects to conclude its investigation early next year, is seeking to determine what authority, if any, the plant has had to mine sand, said Dan Carl, a deputy director of the agency. Cemex officials say they are cooperating with the state probe but don’t believe their operations are causing erosion.

On a recent tour of the facility, plant manager Dale Kendall said Cemex dredges only the sand carried by ocean waves into an intertidal pond, usually during winter storms. A slurry mix of sand and water is then pumped to a plant a half-mile away, where it is dried, sifted and sorted for various markets, he said.

Cemex’s Ms. Engdahl added that the company exercises environmental vigilance in its mining operations, such as not taking sand from the numerous dunes that adorn its property.

Mr. Burnett, the mayor of Carmel-by-the-Sea, suggests that the best outcome would be for Cemex to sell the mine, possibly to the city of Marina for use as a park. Marina officials said they have no such plans.

http://online.wsj.com/news/article_email/SB10001424052702304202204579254312563952176-lMyQjAxMTAzMDEwNTExNDUyWj

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Neuralstem, NFL Alumni Association To Test Feasibility Of Traumatic Brain Injury Treatment

Neuralstem, NFL Alumni Association To Test Feasibility Of Traumatic Brain Injury Treatment

04/24/13 09:51 AM ET EDT

http://www.huffingtonpost.com/2013/04/24/neuralstem-nfl-brain-injury-treatment-_n_3148796.html

 
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NEW YORK — A potential treatment for traumatic brain injuries may be tested in retired professional football players, who are the focus of concern over blows to the head.

Neuralstem, Inc., of Rockville, Md., said Wednesday it is working with the National Football League Alumni Association to study the feasibility of such a test, which would need government approval. It would involve a drug that’s now in an early human trial for treating depression. In animal studies, the drug appeared to stimulate creation of brain cells.

Concern has mounted about brain injuries and disease in former NFL players, driven in part by some high-profile suicides. Thousands of former players are suing the league and its teams, saying that for years the NFL did not do enough to protect players from concussions.

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Targeted Cancer Drugs Keep Myeloma Patients Up And Running

Targeted Cancer Drugs Keep Myeloma Patients Up And Running

by Richard Knox
February 18, 2013 3:34 AM

http://www.npr.org/blogs/health/2013/02/18/172098789/targeted-cancer-drugs-keep-myeloma-patients-up-and-running

Don Wright got diagnosed with multiple myeloma at what turned out to be the right time. It was 10 years ago, when he was 62.

That was at the beginning of a revolution in treating this once-fearsome blood cell cancer, which strikes around 20,000 Americans every year. The malignancy can literally eat holes in victims’ bones, which can snap from the simple act of bending over to pick up a package.
The first treatment Wright had was thalidomide, the sedative that caused awful birth defects in the 1960s. But it didn’t work for long.

Then he got into a study of a related drug called pomalidomide. Earlier this month the Food and Drug Administration approved the drug, which will be marketed as Pomalyst.

Don Wright was diagnosed with multiple myeloma in 2003 only days after completing his first marathon. Since then he has run 70 marathons in all 50 states.

Not only has the drug kept the Minnesota man alive far beyond the three or four years typical for newly diagnosed myeloma patients not so long ago. But it’s also enabled him to keep running marathons.

In the decade since his diagnosis, Wright has averaged seven marathons a year. He’s training for his 71st, which will take place in March on Cape Cod.

“Yesterday I ran 18 miles inside of a soccer dome,” Wright said recently, “and then came back and shoveled snow for 2 1/2 hours. That was a big day.”

Wright was one of the first patients to get Pomalyst, back in 2006. “For me this has been a miracle drug,” he tells Shots. “It’s kept the myeloma stable. And it’s just a little pill.”

Pomalyst is the latest of a half-dozen myeloma drugs developed in the decade or so since Wright got diagnosed. Another, called Kyprolis, won FDA approval last summer.

Like many so-called “targeted” cancer therapies coming out these days, the new drugs are enormously expensive. Pomalyst will cost about $10,450 a month, or more than $125,000 a year.

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“It really has changed the whole landscape for both the doctor and the patient,” he says. “Ten or 15 years ago, it was very depressing to see a new myeloma patient because you knew that the life was potentially short and it was difficult to be overly optimistic about what might transpire.”

Wright is among the 20 to 30 percent of patients who have a less aggressive type of myeloma. But Durie says virtually all patients are benefiting from the new treatment options.

“We can say that 95 to 98 percent of the time we can pretty much guarantee we have a treatment that works — that the patient will go into a remission,” Durie says.

That’s pretty remarkable. But it’s not a cure. Eventually the first drug regimen — whatever it is — stops working and the cancer comes back.

But researchers think they’re on the verge of blocking myeloma’s return for good.
“We’re close, close, close,” says Dr. Ken Anderson of the Dana-Farber Cancer Institute in Boston. “We’re soon really going to change the natural history [of myeloma] in a major way.”

Don Wright shows the drug pomalidomide, which he has been taking as a participant in a clinical trial. Pomalidomide was recently approved by the FDA approved for treatment of multiple myeloma.

That’s doctor-speak for “cure.” Until specialists achieve that cure, they have an expanding bag of tricks to keep the cancer at bay.

New drug combinations and more novel drugs are coming along. Durie notes that scientists presented more than 700 papers on myeloma at December’s American Society of Hematology meeting.

In addition to the new medicines, many patients get stem-cell transplants in an attempt to obliterate nearly all the myeloma cells. But Anderson is leading an international study to determine whether the new drug regimens are so good that risky transplants aren’t needed any more.

“If somebody comes and sees us in the clinic,” Anderson says, “you can look them in the eye and say, ‘You know, it’s highly likely you’re going to live a decade or more. And frankly, with the maintenance therapy, it could be quite a lot longer.’ ”

Marathoner Don Wright has his own definition of a cure.

“The cure for myeloma,” he says, “is to hang on long enough to die of something else. And that is precisely my hope — and my plan, actually.”

You might say he’s in it for the long run.

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* Man with Terminal Cancer has Extraordinary Mission

Surviving Cancer One Marathon at a Time

Man with Terminal Cancer has Extraordinary Mission

By Wendi Jonassen, APRN – Anchorage | June 26, 2012 – 11:45 am

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When Don Wright was diagnosed with myeloma, a kind of terminal blood cancer, nine years ago, the average survival rate was only five years. Wright had run the Boston Marathon before the diagnosis and decided to not let cancer stop him. Over the next few years, Wright continued to run marathons, often visiting different states to do them. With the support of his wife and daughter, he set a goal to run a marathon in every state. The Mayor’s Marathon in Anchorage, Alaska marked his 45th state this last Saturday. He will finish all fifty this December in Hawaii where he will also be celebrating his 50th wedding anniversary.

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Neuralstem

Neuralstem

BY: BILL HOLLERAN

In a November article in Newsweek, science editor Sharon Begley reported on a new development in the search for a cure for amyotrophic lateral sclerosis or ALS, also known as Lou Gehrig’s disease. “Today, if all goes as planned,” Begley wrote, “the first ALS patient will receive an injection of stem cells into the upper part of his spine—the first step toward determining whether the experimental therapy can save ALS patients from dying when their motor neurons, which control muscles, become too weak to maintain breathing.”

The Rockville-based company behind the technology in this clinical trial is Neuralstem Inc. According to the company’s website, Neuralstem’s technology “enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities.” These “regionally specific,” specialized cells are able to “integrate with, and protect, the patient’s spinal cord” because they are “already suited to the task.”

Since that first clinical step, an April University of Michigan Health System news release said, “The first published results from an early-stage clinical trial show that spinal cord stem cells can be delivered safely into the spines of patients with the condition commonly known as Lou Gehrig’s disease, opening the door for further research on this innovative approach.”

What role does innovation play at Neuralstem? “Innovation is what Neuralstem is all about,” said CEO and President Richard Garr. “Normal stem cell technology pushes cells to act like spinal cord and other cells in the central nervous system. But they are not quite the real thing.”

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“This is a completely different, and better, generation of neural cell technology,” he said. “It opens a unique window on the central nervous system.” Garr says innovation is strategically important at Neuralstem because “we only treat fatal or incurable diseases.” In addition to ALS, according to the company’s website, Neuralstem is also targeting central nervous system conditions including spinal cord injury, ischemic spastic paraplegia and chronic stroke.

Another innovation made possible by Neuralstem’s technology is the discovery of what Garr calls “an entirely new class of drugs to treat depression.” According to Garr, “Because our physiologically relevant cells already have the information they need to grow up to what they are supposed to become, we can put them in a petri dish and treat them with toxins. Then drugs can be applied to see how these compounds will interact with the neurons.” Thanks to this discovery, “we are able to test thousands of compounds on these cells.”

As a business, not a lab, said Garr, “being innovative is all about discovering new therapeutic products and creating drugs that can meaningfully improve the quality of life in patients with incurable diseases.” When it comes to stimulating innovation at Neuralstem, Garr said, “We bring a start-up sense of urgency to everything we do. When you are in the business of developing products for patients who are going to die, the sense of urgency is heightened. Our job is to find cures. That’s a strong enabler of innovation.”

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* Mayor’s brings UAA’s Kenyan Connection full circle

Anchorage Daily News

Mayor’s brings UAA’s Kenyan Connection full circle

By DOYLE WOODY
Anchorage Daily News

Published: June 21st, 2012 11:38 PM

http://www.adn.com/2012/06/21/2515318/mayors-brings-uaas-kenyan-connection.html

The man whose email inquiry years ago sparked the dynamic Kenyan Connection for UAA’s cross-country and track programs could prove a pivotal player at the head of the

In the early 2000s, Solomon Kandie, an elite Kenyan steeplechaser at Tulane University, emailed Michael Friess to see if the Seawolves’ running coach might be interested in recruiting Kandie’s younger brother, David Kiplagat. Friess was intrigued and — long story short — pursued the offer.

“A year, year and a half later, David was here,” Friess recalled. “That really started it all.”

Kiplagat became an All-America runner for UAA. He was the forerunner of a wave of Kenyan men and women runners who have helped UAA become a force in Division II cross country and track, and proved to be excellent students and supportive teammates.

Kiplagat last year went after the course record at Mayor’s. Through 22 miles, he was on pace to threaten Michael Wisniewski’s 2009 standard (2:22:29) and seize a $5,000 prize for the record. He faltered in the late going, yet still won handily — his 2:30:52 put him nearly 16 minutes ahead of the runner-up.

Now Kiplagat is ready for another attempt at the record and the $5,000 reward, and Kandie, an accomplished marathoner, will also be in the field as the brothers chase Wisniewski’s record.

“Their plan is to go after the mark, work with each other and try to roll the record,” said Friess, the Mayor’s race director who held the course record for 22 years before Wisniewski cracked it. “I think (Kiplagat’s) in better shape than last year. You know how it is. If it clicks, if the weather’s right, he could do it.”

Kandie, who lives in Albuquerque, N.M., owns a marathon personal best of 2:17:23, which he clocked while finishing seventh in the Sacramento International Marathon in 2011. Earlier this year, he ran 2:22:23 to finish third in the Mississippi Blues Marathon.

A $5,000 prize is also available for breaking the women’s course record — best of luck with that. Chris Clark’s 2:38:19 in 2002 remains 11 minutes faster than any other woman has ever run in race history, and it looks like the 2000 Olympian’s record could stand for ages.

“Until our children are old,” Friess said.

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The top Alaska man and woman in the marathon earn two round-trip tickets from Alaska Airlines.

More than 4,000 runners are expected to compete in the five races folded into Mayor’s — besides the marathon and half-marathon, there is also a marathon relay, a 5.6-miler and 1.6-mile Youth Cup. As of Wednesday, the race featured entrants from 48 states and 16 countries.

Mayor’s offers a unique course for the marathon — 70 percent paved trails and 30 percent unpaved trails. A seven-mile stretch of rolling hills on “tank trails” along the base of the Chugach Range is a scenic, and demanding, section of the course. Also, moose sightings and the occasional bear sighting have occurred in past races.

Like many big running races, Mayor’s has developed into a platform for causes. This year, at least eight different health causes are represented, some for which runners elicit donations or pledges to support non-profits.

Because this is Alaska, Mayor’s has also developed into a destination race, a chance to visit or check a box on a runner’s list of goals.

So it is that Don Wright of Lake Elmo, Minn., is here to cross off another state on his quest to run a marathon in all 50 states. Alaska marks his 45th state — he’s got the remaining five scheduled later this year — and Mayor’s will be his 64th marathon overall.

Wright, 71, an attorney who does computer consulting, is a unique potential member of the 50 States Marathon Club. He runs with multiple myeloma, an incurable blood cancer he was diagnosed with nine years ago.

As part of a study at the Mayo Clinic, Wright takes one pill a day of pomalidomide and thus can avoid chemotherapy, which would leave him too sick to train.

“I’m the beneficiary of modern innovation and technology,” Wright said. “For me, it’s literally saving my life.”

He runs for cancer charities — Team Continuum and Tackle Cancer Foundation — that support cancer patients and their families.

Wright said he also runs to raise awareness that, while he is fortunate to be part of a study of pomalidomide, other cancer patients do not have access to such options.

“We need a better system in our country for people who are dying,” Wright said
Read more here: http://www.adn.com/2012/06/21/2515318/mayors-brings-uaas-kenyan-connection.html#storylink=cpy

 

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The Pill That Could Cure Depression by Growing Your Brain

http://gizmodo.com/5874433/the-pill-that-could-cure-depression-by-growing-your-brain

Kristen Philipkoski:  January 9, 2012

If you are depressed, or schizophrenic or have Alzheimer’s, scientists say you probably have a shrunken hippocampus. The good news: a drug that just entered human trials promises to re-grow that part of the brain.

It’s an entirely new approach to treating clinical depression, which is the first of several diseases scientists at biotech company Neuralstem are hoping to address with their experimental oral drug. Most antidepressants work on brain chemistry, tweaking levels of neurotransmitters including serotonin, norepinephrine, and dopamine. This is the first drug that aims to re-grow patients’ atrophied brains.

Dr. Karl Johe, Neuralstem’s CEO, believes that depression is a three-headed beast that affects neurotransmitter levels, neurons, and hippocampus size. And he says their new drug could address all three. He also hopes the drug will reverse the disease to the point that patients could permanently go off the drug.

“If we can show by MRI that we’ve increased hippocampus volume and at the same time reversed depression symptoms for six months after patients have stopped taking the drug, then we’ll have a cure.”
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That a too-small hippocampus causes depression and other diseases is still technically a theory in humans (though it’s been demonstrated in rats and chimps). So if the drug grows hippocampus volume and thereby treats depression, we’ll not only have a new treatment, but the study results would be proof that a shriveled hippocampus is at least in part the culprit.

The scientists showed first that the drug worked in the lab: They started with dishes of neural stem cells and added several compounds they thought might instigate growth. Seven showed promise, but they could only afford to develop one, so they chose NSI-189. They then tested it in mice; after taking the drug, the rodents had larger hippocampi.

Thirty-five healthy humans have now taken the drug with no ill effects, so the FDA gave the company the OK to start testing in depressed patients. They’ll give the pill to 18 volunteers (six will get a placebo) in three groups, each receiving a progressively larger dose, each over 28 days. They expect this phase, which is mainly to make sure the drugs is safe, to take about six months. If all goes well they hope to proceed to phase two clinical trials later this year, which will test to determine whether the drug is both safe and effective. (After that, a final phase three trial to confirm safety and efficacy will remain before the company can market the drug.)

I couldn’t help thinking about those healthy test subjects who took the drug. Will they get super brain powers? The healthy mice that received the drug did grow extra large hippocampi, the seahorse-shaped part of the brain involved with both short and longterm memory and spatial navigation. Johe isn’t ruling out the possibility of souped-up brains:

“It’s an exciting possibility and we’ll definitely be looking out for it.”

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