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Mich. university joins Lou Gehrig’s clinical trial

USAToday

USATodayhttp://www.usatoday.com/story/news/nation/2013/04/18/lou-gehrigs-disease-clinical-trial/2094867/

Mich. university joins Lou Gehrig’s clinical trial

Robin Erb, April 18, 2013

Study is only one if its kind because neural stem cells are injected into the spinal cord.

(Photo: Kimberly P. Mitchell, Detroit Free Press)

Story Highlights

  • University of Michigan joins Emory University in Atlanta in the clinical trial
  • In the study, human neural cells are injected directly into patients’ spinal cord
  • Currently, there is no cure for amyotrophic lateral sclerosis or ALS

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A clinical trial using human neural stem cells to halt or even reverse the deadly effects of Lou Gehrig’s disease may begin recruiting patients at the University of Michigan as early as this summer.

Until now, the surgeries have taken place at Emory University in Atlanta, led in part by a former U-M neurosurgery resident, Dr. Nicholas Boulis, and overseen by U-M physician and neurology professor Dr. Eva Feldman. The trial is the only one if its kind because the neural stem cells are injected directly into the spinal cord.

At Emory, 15 patients underwent surgery during Phase I, which was focused primarily on safety. At least one appeared to improve dramatically for a short time, regaining use of his legs. Feldman attended each surgery.

The go-ahead Monday by the U.S. Food and Drug Administration to expand the trial to Phase II means the surgeries can take place at U-M as well. The second phase will involve 15 patients split between U-M and Emory, according to U-M and the provider of the stem cells, Maryland-based Neuralstem.

Participants must be ambulatory and live close to those universities.

Currently, there is no cure for amyotrophic lateral sclerosis, often called ALS or Lou Gehrig’s disease. One drug extends life, but usually just by months.

The disease moves swiftly, with most people living two to five years after diagnosis. ALS deadens nerves, withers muscles and, in a final assault, cuts off a person’s ability to breathe even as their mind remains intact.

Dave Murray, 55, of Sterling Heights, Mich., said Wednesday he was “thrilled” by the trial’s move to U-M, though it’s unclear whether he would be eligible.

The former security alarm installer already has been a participant in two other clinical trials.

“I might be past the point of eligibility, but I’m always happy with any news that we might be moving forward,” he said. “It’s such a horrible disease.”

Two years ago, he was sitting with his coat draped over his arms on an exam table when a doctor gave him the diagnosis, and told him he had three, maybe five, years left. Only the sound of his doctor washing her hands at the tiny sink broke the suffocating silence that followed.

“The doctor, she was very compassionate,” recalled his wife, Sheryl Murray. “She left us room to cry. She said, ‘Take whatever time you need.'”

Feldman, the physician overseeing the trial, has spent her career stalking ALS and searching for a cure. She has watched helplessly as countless patients have died over the years — as many as five a week and as young as 16, she told the Free Press in 2012.

The trial is still early and will move slowly as she and other researchers continually assess their results and report the findings to the FDA.

Phase II means researchers can begin assessing the effectiveness of the procedure, not just its safety. In a lengthy surgery, a specially designed apparatus is attached to the spine and inserts human stem cells into a person’s spinal cord.

Feldman and others theorize that these new cells, once in the spinal cord, act as nursemaids to damaged nerve cells, sending out repair signals, and somehow halting the progression of the disease.

The cells were derived from a cell line that dates to the spinal cord of an aborted fetus in 2000. The cells are different from the embryonic stem cells that were the subject of a controversial ballot proposal in Michigan in 2008, when voters approved lifting the ban on embryonic stem cell research.

U-M’s Institutional Review Board, which oversees clinical trials to make sure they are scientifically and ethically sound, must sign off on the experimental surgeries before U-M begins recruiting.

Despite its limitations, the trial offers hope for those who see little of it once they are handed a diagnosis, said Sue Burstein-Kahn, executive director of ALS of Michigan. Her father died of ALS.

She called the FDA approval “wonderful” in that it could provide insights to a treatment for future patients.

“We need ALS research fast-tracked,” she said.

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U-M may recruit ALS patients for stem cell clinical trial

Detroit Free Press
Detroit Free Presshttp://www.freep.com/article/20130417/NEWS06/304170160/U-M-may-recruit-ALS-patients-stem-cell-clinical-trialDr. Eva Feldman is overseeing the clinical trial. / Detroit Free Press

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By Robin Erb
Read the full article by clicking here

A clinical trial using human neural stem cells — injected into the spinal cord — to halt or even reverse the deadly effects of Lou Gehrig’s Disease may begin recruiting patients at the University of Michigan as early as this summer.

Until now, the surgeries have taken place at Emory University in Atlanta, led in part by a former U-M neurosurgery resident, Dr. Nicholas Boulis, and overseen by U-M physician and neurology professor Dr. Eva Feldman. The trial is the only one if its kind because the neural stem cells are injected directly into the spinal cord.

At Emory, 15 patients underwent surgery during Phase I, which was focused primarily on safety. At least one appeared to improve dramatically for a short time, regaining use of his legs. Feldman attended each surgery.

The go-ahead Monday by the U.S. Food and Drug Administration to expand the trial to Phase II means the surgeries can take place at U-M as well. The second phase will involve 15 patients split between U-M and Emory, according to U-M and the provider of the stem cells, Maryland-based Neuralstem.

Participants must be ambulatory and live close to those universities.

Currently, there is no cure for amyotrophic lateral sclerosis, often called ALS or Lou Gehrig’s disease. One drug extends life, but usually just by months.

The disease moves swiftly, with most people living two to five years after diagnosis. ALS deadens nerves, withers muscles and, in a final assault, cuts off a person’s ability to breathe even as their mind remains intact.

Dave Murray, 55, of Sterling Heights said Wednesday he was “thrilled” by the trial’s move to U-M, though it’s unclear whether he would be eligible.

The former security alarm installer already has been a participant in two other clinical trials.

“I might be past the point of eligibility, but I’m always happy with any news that we might be moving forward,” he said. “It’s such a horrible disease.”

Two years ago, he was sitting with his coat draped over his arms on an exam table when a doctor gave him the diagnosis, told him he had three, maybe five, years left. Only the sound of his doctor washing her hands at the tiny sink broke the suffocating silence that followed.

“The doctor, she was very compassionate,” recalled his wife, Sheryl. “She left us room to cry. She said ‘Take whatever time you need.’ ”

Feldman, the physician overseeing the trial, has spent her career stalking ALS and searching for a cure. She has watched helplessly as countless patients have died over the years — as many as five a week and as young as 16, she told the Free Press in 2012.

The trial is still early and will move slowly as she and other researchers continually assess their results and report the findings to the FDA.

Phase II means researchers can begin assessing the effectiveness of the procedure, not just its safety. In a lengthy surgery, a specially designed apparatus is attached to the spine and inserts human stem cells into a person’s spinal cord.

Feldman and others theorize that these new cells, once in the spinal cord, act as nursemaids to damaged nerve cells, sending out repair signals, and somehow halting the progression of the disease.

The cells were derived from a cell line that dates to the spinal cord of an aborted fetus in 2000. The cells are different from the embryonic stem cells that were the subject of a controversial ballot proposal in Michigan in 2008, when voters approved lifting the ban on embryonic stem cell research.

U-M’s Institutional Review Board, which oversees clinical trials to make sure they are scientifically and ethically sound, must sign off on the experimental surgeries before U-M begins recruiting.

Despite its limitations, the trial offers hope for those who see little of it once they are handed a diagnosis, said Sue Burstein-Kahn, executive director of ALS of Michigan. Her father died of ALS.

She called the FDA approval “wonderful” in that it could provide insights to a treatment for future patients.

“We need ALS research fast-tracked,” she said. “This isn’t even about a cure. People would be happy with the treatment.”

Contact Robin Erb: 313-222-2708 or rerb@freepress.com.

Kofi Myler

What’s next?

■A University of Michigan Institutional Review Board will review the protocols for the trial, considering the ethics and science of the experimental procedure.
■ The university cannot begin recruiting until the the board OKs the trial. The approval process could take months.
■ Once approval is given, the research team, made up of doctors, nurses, researchers and others, may begin recruiting. Because the trial will likely involve fewer than 15 patients at U-M, it’s unclear how they will be recruited.
■U-M most likely will post recruiting information on its clinical trials website,www.umclinicalstudies.com. For general information for ALS patients wishing to take part in U-M research, e-mail jkballar@umich.edu.

Kofi Myler
Kofi Myler

 

 

Posted on

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.

Posted on

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.

Dr. Brian Durie of the International Myeloma Foundation says the availability of these new drugs has been transformative.
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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.

Posted on

Scientists Seek Stem Cell Cure For Spinal Cord Injuries

WAMU

WAMUScientists Seek Stem Cell Cure For Spinal Cord Injuries

By: Emily Berman // January 25, 2013

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or continue to read the condensed transcript here
Thomas Hazel PhD and Richard Garr @Neuralstem
Thomas Hazel, Ph.D, and Richard Garr pose in their neural stem cell laboratory, in Rockville, Md.

Neuralstem, a Rockville-based biotech company, has just been approved by the FDA to begin implanting stem cells into people with spinal cord injuries. While there’s a long scientific journey ahead, this trial could mean hope for paraplegic and quadriplegic patients all over the world.

The nervous system works, by sending electrical signals up and down the spinal cord. Degenerative diseases like Multiple Sclerosis, ALS, or Parkinsons impair the ability to send those signals. “There’s a gap,” says Richard Garr, co-founder and CEO of Neuralstem. He says there’s something that’s blocking signals from getting through.

Unlike our skin cells, the central nervous system doesn’t repair itself when damaged. “You’re born with a certain number of neurons, and that’s the way it is.” says Garr.

In 1998, Garr met Karl Johe, Ph.D. who had made a discovery while working at NIH. Around week 7 or 8, when the human embryo is the size of the tip of your thumb, there are cells in the brain area of the embryo that have all the information they need to become neurons. These are called ‘neural stem cells.’ Dr. Johe developed and patented techniques for extracting and multiplying these cells, then implanting them as ‘replacement neurons.’

“We’re actually putting in cells that are going to turn into neurons that are going to bridge the gap,” he says. “We’re creating new circuitry.”

Dr. Thomas Hazel, the head of Research at Neuralstem, explains one of the most important aspects of neural stem cells is that they can easily replicate. The lab received a donated tissue from a legally aborted fetus about 10 years ago, and they’ve been using those cells ever since.

The surgery recently approved by the FDA is much like an earlier trial, done on ALS patients. The surgeon injects neural stem cells directly into the patient’s spinal cord. Those stem cells grow into neurons, and if all goes according to plan, they help messages pass from the brain to muscles.

The ALS trial is waiting for phase 2 approval, but patients, on their own, are reporting some improvement. The spinal cord trial will take on eight patients who have experienced injury in the past 1 to 2 years in the thoracic spine, which is from the chest, down. Neuralstem will announce the partner hospitals in the coming months, and hope to start the surgeries in summer 2013.

Posted on

Bespoke Stem Cells for Brain Disease

excerpt from article: “Over the last 2 years, stem cell therapies have done well in early clinical trials for sporadic neurological diseases, such as ALS and macular blindness. Such therapies have also shown promise for spinal cord injury, and just this week, the US Food and Drug Administration gave approval to the biopharma NeuralStem to begin a Phase I trial with fetal stem cells. It is the second US stem cell trial for spinal cord injury;“

Click Here to read the online article

TheScientist

Bespoke Stem Cells for Brain Disease

Scientists use virus-free gene therapy on patient-derived stem cells to repair spinal muscular atrophy in mice.

By Nsikan Akpan | January 15, 2013

Most children with spinal muscular atrophy (SMA) will never jump rope, play tag, or even walk because a genetic deletion will provoke the gradual destruction of their spinal motor neurons. By correcting this mutation in stem cells derived from patients, Italian scientists have successfully curbed the progression of the disease in a mouse model. The results, published last month (December 15) in Science Translational Medicine, suggest that SMA sufferers may one day serve as their own donors for neuron transplants to treat their disease, according to a report.

“[It] is a beautiful study of the potential for using induced pluripotent stem cells (iPSCs) to treat genetic diseases,” said Lisa Ellerby from Buck Institute for Research on Aging, who was not involved in the study but is currently investigating the use of the technique to treat Huntington’s disease (HD).

Over the last 2 years, stem cell therapies have done well in early clinical trials for sporadic neurological diseases, such as ALS and macular blindness. Such therapies have also shown promise for spinal cord injury, and just this week, the US Food and Drug Administration gave approval to the biopharma NeuralStem to begin a Phase I trial with fetal stem cells. It is the second US stem cell trial for spinal cord injury; Geron abruptly halted the first in 2011.

Adding gene correction to the equation could expand their scope to treat a wide array of inherited disorders, Ellerby said. “As the field demonstrates that patient cells can be genetically corrected, we are closer to using this new technology to either model the disease or develop therapies for human patients.”

SMA is the leading genetic cause of infant mortality, killing one of every 6,000 babies born worldwide. The disease arises when a person fails to inherit a partially deleted version of the survival motor neuron 1 (SMN1) gene, which regulates multiple cellular processes involved with RNA metabolism. There is no cure.
Hence, sildenafil uk not only guide man to deal with inflexible erection, but it also usher the sexual wish require to marmalade erection & relate quiet the crest. Unauthorized spare parts serve more harm viagra 25 mg recommended than any good. Since depression is closely related to one ‘s mind-or personality inside, the way this condition is complex cheap brand viagra and subtle. prices of viagra Anxiety and impotence are linked with each other so profoundly that 1 out of 2 cases of anxiety disorders, including panic attacks, the body produces more adrenalin, which is known as “fight or flight” response.
Somewhere along the evolutionary road to becoming human, the SMN1 gene was duplicated, resulting in SMN2, which can partially compensate for the dearth of SMN1 in SMA patients. Every SMA patient possesses an SMN2 gene. Those with multiple copies of SMN2 experience less severe SMA and typically survive into adulthood. But SMN1 and SMN2 are not identical: a single nucleotide difference impairs the pre-mRNA splicing of SMN2, such that its functional protein is produced at one-tenth the rate of the SMN1 protein.

Neurologist Giacomo Comi of the Univerity of Milan reasoned that if the single differing nucleotide of SMN2 were changed to mimic SMN1 in spinal neurons, perhaps the cells could survive. Rather than correct the SMN2 gene in endogenous SMA neurons, which may be dead or dying by the time the disease is recognized, Comi proposed replacing them entirely with iPSC transplants carrying a corrected copy of SMN2.

“The ideal therapeutic approach for SMA will be a combined strategy of molecular therapy to resolve the genetic defect and cell transplantation that can complementarily address signs of the disease,” said first author Stefania Corti of the University of Milan.

To accomplish this goal, Comi and his colleagues reprogrammed skin cells from SMA patients into iPSCs. The researchers then transfected the iPSCs with sequence-specific oligonucleotides that can repair genes with single base mutations. (In both steps, the researchers avoided using viral vectors because of the risks of tumor formation or harmful immune responses following transplantation.)  Finally, the genetically altered iPSC cells were differentiated into motor neurons and transplanted into mice that displayed symptoms of SMA.

SMA pups that received spinal grafts of “corrected” SMA-iPSC-derived neurons a day after birth showed significantly less spinal neuron loss and muscle atrophy. They were more physically active and stronger, as judged by open-field and grip tests. Neuron transplantation also extended lifespan by 50 percent.

The results suggest that the implanted neurons integrated into the spinal cord to alleviate motor dysfunction. Indeed, fluorescent histology revealed that the transplanted neurons formed neuromuscular junctions with muscle tissue near the spine. The implanted neurons also promoted the survival of the endogenous neurons still carrying the SMA mutation, indicating that the therapy provided neuroprotective benefits to the surrounding tissue as well. When grown in culture, corrected iPSC-derived neurons secreted more growth factors than uncorrected neurons, which may explain this transfer of vitality.

Of course, the research is very early stage, and many years of work will be needed to translate this success to the clinic, but “the implications are significant, not just for SMA disease, but also for similar neurodegenerative conditions like ALS and other neuromuscular diseases,” said Corti. “These data demonstrate the feasibility of generating patient-specific cells that are free of disease.”

S. Corti et al., “Genetic correction of human induced pluripotent stem cells from patients with spinal muscular atrophy,” Science Translational Medicine, 19:165ra162, 2013.

Posted on

Neuralstem’s stem cells give spinal injury patients hope

Neuralstem’s stem cells give spinal injury patients hope

FDA gives Rockville biotech green light for initial trial

By Lindsey Robbins

This story was corrected on Jan. 15, 2013. An explanation follows the story.

Richard Garr NeuralStem CEO
Richard Garr NeuralStem CEO

Physicians, researchers, patients and their advocates in the spinal injury field are keeping a close eye on Rockville biotech Neuralstem as it prepares to launch a Phase 1 safety trial of its stem cell treatment for chronic spinal cord injury.

The Food and Drug Administration approved the trial Monday. Neuralstem plans to conduct the study on eight patients who are completely paralyzed at or below their spinal cord injuries.

“It’s important that people understand this is very different from other methods that have gone on before,” CEO Richard Garr said. “This is the real deal. We have compelling data. Cells are surviving, grafting and doing what we would expect they would do.” The FDA go-ahead follows Neuralstem’s report in October that rats given the stem cell product, NSI-566, seven days after suffering an ischemic stroke showed improvement in motor and neurological tests.

“Should this prove to be successful, it will allow for some regeneration of human spinal cord cells and for people to regain function. It will be an incredible breakthrough, with huge implications for the health care market,” said Paul Tobin, president and CEO of the National Spinal Cord Injury Association.

More than 10,000 people in the U.S. sustain spinal cord injuries each year, according to the Christopher & Dana Reeve Foundation. About 840,000 people have chronic spinal cord injury. Currently, the best treatment is mitigating secondary damage and providing environments and tools that support patients with these injuries, Tobin said.

While Tobin emphasized that the industry is still “far from a cure yet,” the Neuralstem treatment could be a tremendous step and appears to be worth exploring.

The primary objective of the study is to determine the safety and toxicity of human spinal stem cell transplants for treating paralysis and related symptoms due to chronic spinal cord injury, according to Neuralstem information. A secondary objective is evaluating graft survival in the transplant site.

All patients will receive six injections in or around the injury site, with the first four patients receiving 100,000 cells per injection and the second four receiving 200,000 cells per injection. The study will follow the patients for six months after the procedures.

Following Monday’s announcement, stock analyst Aegis Capital of New York raised its 12-month price target for Neuralstem to $4 from $3.50.

“Investors should note the fact that spinal cord injury is the clinical indication that most closely mirrors the situation in the preclinical rat model that yielded the ground-breaking data published in the [trade journal] Cell last year,” Aegis wrote in a report Monday.

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Aegis described itself as “cautiously optimistic” about Neuralstem’s treatment, but said the stem cell lines are still in “comparatively” early stages of development and that stem cell research, in general, faces uncertainty. Neuralstem’s stem cells are not from embryos.

Aegis also cautioned that Neuralstem had $9.9 million in cash and equivalents as of Sept. 30, with a monthly cash burn estimated as high as $1.5 million. Garr said Neuralstem is not planning fundraising in the immediate future.

Garr said the Phase 1 trial should begin this spring.

Other stem cell studies

Next month, Neuralstem plans to begin dosing patients with NSI-566 to treat paralysis from stroke in China, with a trial in Korea scheduled for the summer.

Neuralstem already has completed dosing in its Phase 1 trial at Emory University in Atlanta for amyotrophic lateral sclerosis. The trial will end six months after the last surgery. That therapy has received orphan status designation from the FDA, which confers certain advantages, such as a more streamlined process.

Though other companies have looked into this treatment, Neuralstem is the only one with an FDA-approved spinal cord injury trial using stem cells.

Geron Corp. in California had been conducting stem cell spinal cord injury trials in the U.S. but ended up shutting down that portion of its business in November 2011 and later sold it. StemCells is conducting trials in Switzerland.

Neuralstem officials said they hope success with this treatment allows for applications in chronic stroke motor disorder and multiple sclerosis.

“People should take hope,” Garr said.

Karl Johe, Neuralstem’s chairman and chief scientific officer, said the biotech’s data from other studies justify the new trial and the company’s confidence.

“In addition to the pre-clinical animal data, we have conducted 18 successful surgeries using the same cells and surgical device in our ALS trial,” Johe said in a statement. “That trial has demonstrated that the surgical route of administration and the cells are safe and well-tolerated and that the cells survive long-term in the patients. The successes of our human clinical experience, combined with the compelling data from the preclinical spinal cord injury animal studies gives us confidence that we are prepared to move into this additional indication for NSI-566.”

lrobbins@gazette.net

Explanation: The original version omitted a word from this quote by Richard Garr: “Cells are surviving, grafting and doing what we would expect they would do.”

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* Don Wright Interview by Dr. Sanjay Gupta

KOSIK: And every week, Dr. Sanjay Gupta brings us incredible stories of recovery and survival from around the world. In today’s “Human Factor,” our chief medical correspondent reports on a 71-year-old who’s continued his dream of running marathons while fighting a dangerous form of cancer, one where patients are rarely cured.

http://www.cnn.com/video/#/video/health/2013/01/09/human-factor-don-wright.cnn

SANJAY GUPTA, CNN CHIEF MEDICAL CORRESPONDENT: Don Wright’s career spanned engineering, being a company vice president, and the law. At age 62, he discovered a new passion — marathons. Nine year ago, days after running his first 26-mile race, he got some devastating news.

DON WRIGHT, MARATHON RUNNER/CANCER PATIENT: I had gone to the doctor a couple of times for pain in my back. It was multiple myeloma.

GUPTA: This is a cancer of the blood where the white blood cells invade the bone marrow causing pain, usually in the back or the ribs. Patients are rarely cured. But Wright refused to let that slow him down, even qualifying for the Boston marathon.

WRIGHT: We got this devastating diagnosis, and we just — my family and I, we just kept on going. You know, there wasn’t any reason to stop and be sorry, you know. We kept running marathons.

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WRIGHT: It feels wonderful, I’ll tell you. A philosophy of life that I have is live one day at a time and make it a masterpiece, and that was a masterpiece.

GUPTA: Wright wasn’t sure he could fulfill his dream because the median survival for his cancer is just five years. Prognosis does vary depending on age and stage of the disease. He’s had a number of treatments that have failed. But for the last four-and-a-half years, Wright’s taken an experimental drug, one pill at night, that’s worked. It’s kept the cancer at bay.

WRIGHT: It doesn’t cure the cancer, but it keeps it stable so it’s not hurting me. And I can still run. And I can still enjoy life, and I’m riding that for all it’s worth.

GUPTA: His advice to others facing what seemed like insurmountable odds, take charge of your own destiny and never give up hope.

Dr. Sanjay Gupta, CNN, reporting.

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* A Minnesota man who has incurable cancer hits a big milestone

http://www.kvue.com/news/182916671.html

by WCNC

kvue.com

Posted on December 10, 2012 at 8:43 PM
Updated Tuesday, Dec 11 at 7:18 AM

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A Minnesota man who has incurable cancer hits a big milestone.

Seventy-one-year-old Don Wright reached his goal of running marathons in all 50 states. He hit 50 this Sunday in Honolulu.

“My family and I have been running marathons in every state, and that’s been our goal, and we’ve run marathons now in 49 of the 50 states,” Wright said before the race on Sunday, “The diagnosis for my cancer was a three to five-year median survival. It feels like when I’m running along in a marathon, I’m just sticking my finger right in that cancer’s eye.”

Wright has a type of blood cancer.

He says he’s been able to control his battle thanks to a drug that’s being used in clinical trials.

And, he says he’ll keep running as long as he can.

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* Cancer survivor runs his 50th marathon in the 50th state

http://www.hawaiinewsnow.com/story/20292980/cancer-survivor-runs-his-50th-marathon-in-the-50th-state

Cancer survivor runs his 50th marathon in the 50th state

Posted: Dec 07, 2012 10:42 PM EST Updated: Dec 08, 2012 1:43 AM EST

By Teri Okita – bio | email

HONOLULU (HawaiiNewsNow) –

Come Sunday morning, organizers are expecting more than 31,000 runners at the Honolulu marathon. In that crowd, a Minnesota man will, appropriately, be running his 50th marathon in the 50th state.

But Hawaii News Now found out: there’s much more to his story.

Don Wright has had plenty of practice crossing the finish line. This Sunday, he’ll have run a 26.2 mile marathon in every state in the nation.

“That’s pretty. I can’t wait ’til I’m running under that!” says Wright – as he looks at the finish line sign that’s not even hung up yet.

At age 71, not many people can say they’ve finished one marathon – let alone 50. It’s pretty impressive for a guy who just picked up running decade ago.

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Age is the least of his challenges. The St. Paul-area man was diagnosed with multiple myeloma – a blood cancer that affects cells in bone marrow. He was given about five years to live – that was nine years ago.

Running became his path to survival.

“It gives me a chance to make a point that people who have cancer can still have active, vital lives,” he says.

When Wright crosses the finish line on Sunday, he figures he will have logged 12,000, maybe 13,000, miles training and running these marathons.

Do the math. That’s like running from one coast to another – Los Angeles to New York – almost five times! His last marathon was just five weeks ago, and in 2011, he ran more than one marathon a month.

“He’s a runner, not a myeloma victim,” says his wife, 73 year old, Ardis. The Wrights and their daughter often race with together.

He’s stabilized on an investigative cancer drug called pomalidomide and needs no infusions or transplants. “We’re free because all he has is that little pill bottle, and he takes one pill every night and we can go,” says Ardis.

And go they do – successfully on the run from cancer.

Copyright 2012 Hawaii News Now. All rights reserved.