http://www.freep.com/videonetwork/1770833471001/ALS-Living-with-Mortality
ALS strikes at random, killing young and old
By Robin Erb
Detroit Free Press Medical Writer
To Read The Full Article Click Here
Sometimes she glares at the painting of Jesus in her dining room.
“I just let it loose,” said Mary Kleiss at her Royal Oak home. “I look at that picture and I say, ‘You get down here and put on your boxing gloves and let’s get this over with.’ I am so damned angry.”
Her son, Regis, was diagnosed two and a half years ago with Lou Gehrig’s disease — amyotrophic lateral sclerosis, or ALS. It is, he writes, “as if God is torturing me.”
The disease kills with stunning efficiency — deadening its victims’ peripheral nerves, withering muscles and, in a final assault, shutting down their ability to breathe. An estimated 30,000 people have it at any given time; 5,000 are diagnosed yearly. Most die within years. There is no cure.
The disease has reduced Regis Kleiss, 28, a formerly thick-bodied shot and discus thrower and captain of the track team at Dondero High School, to a bony echo of himself. Paralyzed except for some minor movement of his head, he will spend his final days on a feeding tube.
ALS leaves its victims’ minds intact.
“It’s a miserable, damned disease,” his mother said.
Now, a clinical trial overseen by the University of Michigan may provide hope. It is cutting-edge and audacious work — the only ALS trial so far in which neural stem cells are injected directly into a patient’s spinal cord. So far, 15 patients have undergone the procedure — two of them twice — as the FDA monitors its safety.
One patient showed a remarkable improvement for a while, though U-M’s Dr. Eva Feldman, who heads the research, cautions not to read too much into that. The other 14 showed no improvement.
The trail is tentative and early. But when the rest of a person’s life has been compressed to an expectancy of two to five years, it is hope nonetheless.
The trial has been based in Atlanta since 2010, but U-M has requested approval from the U.S. Food and Drug Administration to expand it and move it to the University of Michigan in Ann Arbor.
The trial involves injecting 500,000-1 million stem cells into the spine. The ancestry of the cells 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.
Feldman and others theorize that these new cells act as nursemaids to damaged nerve cells, sending out repair signals, and somehow halting the progression of the disease.
The procedure worked in rats. It has been shown to be safe in pigs.
If the FDA approves moving the trial to Ann Arbor, Michigan patients will have access to an experimental treatment that not only might offer insight into a disease that kills an estimated 15 Americans a day, but also push back the battle lines against other neurodegenerative diseases, such as Parkinson’s and Alzheimer’s or Huntington’s.
“There is a lot of potential here,” said Sue Burstein-Kahn, executive director of ALS of Michigan, a Southfield-based nonprofit.
Last month, Feldman flew down with a team of U-M staff for the 17th surgery in the trial, in anticipation that the trial might soon move to Ann Arbor. The trial has been at Emory University in Atlanta since it began, in part, because Feldman wanted a former U-M neurosurgery resident, Dr. Nicholas Boulis, who is now at Emory, to perform the delicate procedure. Boulis collaborated with Feldman on her research for seven years during his residency.
Feldman is clear and she repeats this often: This part of the trial tests safety only. By design, it doesn’t
assess the efficacy of the treatment yet.
So the clinical trial patients so far — all from the Atlanta area — know the experimental stem cell therapy probably will not cure them. Still, they’re empowered, knowing their participation might one day cure others, said Ed Tessaro, a retired Macy’s executive, from his home overlooking a sparkling Georgian lake.
The following morning, Tessaro, 66, lay on an operating room table at Emory’s hospital, as doctors sliced through his skin and muscle, removed part of the bone in his spine and laid bare a pulsating, bright-white spinal cord for a second infusion of stem cells.
“It may kill us,” Tessaro said of the disease, “but it’s not going to defeat us before we die.”
Serving a greater purpose
It was 2008 when a single misstep and near-stumble during a half-marathon in Bangkok, Thailand, first worried Tessaro. It happened more than once. His muscles weakened, even as he stepped up his time at the gym.
Months later, a fresh, young doctor delivered the news to him and his wife, Judy.
They remember it well, even now.
“She said, ‘It’s the worst thing I could tell you,’ ” Judy Tessaro recalled.
” ‘You have ALS, and you have two to four years to live,’ ” Ed Tessaro added.
The doctor cried that day. So did Judy and Ed.
“The dynamics are pretty grim — fatal, no cure. Nobody has ever been cured. … It takes a while to get your head wrapped around that kind of reality,” Ed Tessaro said.
But Tessaro took stock. Life had been good, he decided.
Tessaro has been married for 43 years. He has a daughter and son and is a grandfather to two little girls. When he speaks of them, he can’t help but grin. And the pictures in the downstairs rec room at the Tessaros’ home are of a thrill-filled life: ice-climbing in New Zealand, marveling at the lush green of Vietnamese rice paddies, being stunned by the chase-and-dart flurry of a cheetah taking down a Thomson’s gazelle in the Serengeti.
Hiking. Biking. Skydiving.
He thought life couldn’t be more vivid. He was wrong.
Now, every conversation, every gentle touch from his wife, the babbling of his grandbabies — his senses are now in hyperdrive.
“In retrospect, I was living in analog. What I’m now living my life in is high-definition. … I’m living my life fully, because I know I have less of it,” Tessaro said.
When he heard about the clinical trial, Tessaro jumped at it, calling it “the larger-purpose stuff.”
“It’s not like I can hope for a miraculous reversal of this disease — it’s not coming,” he said. “I don’t think I have anything to lose … and I can be part of something bigger. It’s great therapy when you commit yourself to something bigger.”
He became Patient No.12 on April 13. Doctors slipped stem cells into the lower — or lumbar — section of his spine. The area that controls lower body movement, it was considered least risky because Tessaro was already losing the strength in his legs anyway. Clinical trial protocol limits risk.
Tessaro survived. In fact, he left the hospital days earlier than expected and felt better sooner than he expected.
So doctors decided — and the FDA approved — a second, riskier, surgery for Tessaro. This time, doctors would move to the upper — or cervical — portion of Tessaro’s spine, the area in which the nerves are responsible for breathing.
Feldman calls this area “precious real estate,” the stretch of spine where researchers say they believe the treatment may be most effective.
“Higher risk, but maybe higher reward,” Tessaro said, shrugging. He was in the pre-operating room of Emory University Hospital, surrounded by family and overnight bags and medical tubes and equipment.
It was July 20.
In a stretch of hallway and an elevator ride away, a nondescript FedEx box was being delivered to Dr. Jonathan Glass, director of the ALS clinic at Emory. His hands were working quickly.
Preparing for surgery
Glass pulled from the temperature-controlled container several vials of the stem cells known as NSI-566RSC. They had been thawed to about 39 degrees and then shipped overnight to Emory by Neuralstem, a Rockville, Md.-based biomedical company that is funding the trial, according to CEO and President Richard Garr.
The company has shelled out about $2.5 million for the first phase of the trial and provided the stem cells, one of the company’s premier products. They were drawn and cultured from the spine of an aborted fetus in 2000, then cultured again. They remain frozen until the day before they are ready for use.
They have arrived at Emory at 8 a.m. each surgery day of this trial — “never been late,” said Jane Bordeau, a research nurse and coordinator for the trial at Emory.
Glass separated out some of the liquid to test in separate vials, slipping some drops of blue liquid into the vials and tapping them lightly with a middle finger. He slid them onto a slide and rolled his chair to a microscope.
Dead cells will glow blue, he explained, having absorbed a dye that seeps inside their degrading membranes. Live cells remain clear and bright. At least 70% must be alive to be considered viable and to begin surgery, according to Neuralstem.
Glass began counting.
In an upstairs operating room, a red second hand circled a wall clock.
In the pre-op room, Tessaro had been discussing the 25 videos he planned to make for his toddler-age grandchildren. He knows ALS will steal his voice. So he will travel to the Smoky Mountains, set up a tripod and record for them stories, like how he met their grandmother.
He talked about the two books in his overnight bags, too: Hemingway’s “Farewell to Arms,” and — he added, laughing — “Fifty Shades of Grey,” because his daughter dared him.
Nearby, his wife was quiet. She fidgeted with an overnight bag.
In his lab, Glass punched some buttons on his cell phone calculator.
“It’s cool,” he announced. By his calculations, 83.6% of the cells had arrived alive.
It was time. The surgery would go as planned.
Surprising the doctors
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Ted Harada is on Page 8 of the March Journal of Stem Cells, which published the first study announcing the preliminary results of the first 12 patients.
Harada is the anomaly. Patient No. 11. Like Tessaro did last month, Harada this month will undergo a second surgery. And like with Tessaro, it took some time to diagnose the mysterious weakening of Harada’s body.
The former FedEx managing director, now 40, noticed he was getting winded in 2009 while playing Marco Polo in the family pool with his three children: “I’d go under water and come back up, and I was sucking for air.”
After a string of doctors — a family doctor, an orthopedist, a neurologist — the final diagnosis came in August 2010: ALS. The diagnosis was devastating, but the timing couldn’t have been better, the neurologist told him.
Clinical trial #NCT01348451 was under way.
By the time Harada, a self-described type A personality, went in for his surgery in March 2011, he was using a cane, unable to walk to the end of the driveway for the mail without losing his breath or to climb the 15 stairs to tuck his children in at night.
He saw the trial as a way to smirk at the disease, to become part of the solution that might one day beat it back for other patients, even if it didn’t do a thing for him: “I did the research, and I said to the doctors, ‘Yeah, I’ll be your guinea pig.’ ”
To his way of thinking, someone had to be the first man on the moon. Someone has to step up for medical research.
Plus, he added, “I know how the book ends if I do nothing.”
But what happened after his surgery wrote a chapter no one had expected.
The 14 other patients involved in the trial to date have shown no improvement; four have died — three from complications of ALS, and the other from a heart-related issue, according to Neuralstem.
In contrast, Harada put aside his cane soon after the surgery. And he was again tucking his children into their beds.
Feldman is insistent: Don’t read too much into Harada’s turnaround. The number of patients is tiny, and Ted is an oddity among them.
Still, Harada’s improvement, even if temporary, can’t be ignored.
The researchers have used several tests to measure patients’ outcomes, such as breathing capacity, the strength of their handgrip, and even the electrical impulses that flow through their muscles. There on these graphs is Harada, his dotted lines suddenly shooting upward after surgery.
In designing the clinical trial, “we were only aiming at stopping the disease,” said Dr. Karl Johe, chairman and chief scientific officer of Neuralstem. “But this is a patient that has clearly improved.”
Recently, Harada has begun to get winded again climbing the steps to his children’s bedrooms. He and wife, Michelle, 39, a sixth-grade teacher, have explained to their children that he probably won’t get better this time.
In her worst moments, Michelle has foreseen graduations and Christmases and grandchildren without him.
In their kitchen, the Haradas’ children had just finished slathering peanut butter on bread and disappeared upstairs. A deeply religious couple, the Haradas said they’ll take what they can get.
“We’ve been blessed,” he said.
Michelle Harada agreed, struggling against a surge of tears: “The surgery gave us two years back.”
Paving the way for others
Ed Tessaro was facedown, mostly draped in surgery blue in the crowded Emory operating room . It was 12:23 p.m. on July 20.
A stainless steel, crane-like contraption had been screwed into the cervical section of his spine. A steady beep-beep-beep of the monitors punctuated the hiss of a respirator. A digital camera recorded every movement for the FDA.
Standing just a few feet from Boulis, Glass was ready, with the spinal cord exposed.
It was 2:34 p.m. when Boulis asked for the cells.
For the next half hour, the vials were readied for the patented apparatus, on which an injection device slid along a guide to Tessaro’s spinal cord. It would inject 100,000 cells for each of five stops precisely 4 millimeters apart.
The target was the ventral horn of the spinal cord, a tiny area associated with motor neurons.
“Just looking at the spine can hurt it,” Glass had said earlier.
At 3:06 p.m., the injection device slid into place. A needle extended, injecting deep into the spinal cord and, for two minutes, the stem cells were forced into the ventral horn.
At 3:29 p.m., the fifth and final injection began, and two minutes later, the relief was palpable. From her viewing spot just a few yards from Tessaro’s neck, Feldman shifted on her feet and exhaled. The procedure, from start to finish, took a little more than six hours.
Technicians began to check recordings and run over the notes for the FDA. Boulis and the others began the process of removing the device and closing in the gaping hole in Tessaro’s back.
“Can we get some music in here?” Boulis said.
Whiz Khalifa’s rap filled the OR.
Feldman transferred the digital recording of the process to a memory stick she could review back at the office. A copy would go to the FDA, too.
There will be many more months of data, continued animal tests and most likely, hundreds of pages of reports.
Even if this early stage is proved safe and the clinical trial continues, doctors must figure out whether these are the stem cells that work best in this therapy, and, if so, in what amounts and injected into which areas. There’s the issue of the patients’ bodies rejecting these foreign bodies, too.
“This is not a small molecule pill, and your patients go … home and take the pill and you see them in your clinic in a few months,” said Steve Perrin, CEO of ALS Therapy Development Institute, a Massachusetts-based nonprofit focused on finding a treatment or cure for ALS. “These are the challenges this trial and this technology have in front of (them). They’re paving the road, because no one has been down this way before.”
On Friday, Tessaro was recuperating at home.
Waiting for any good news
In the Kleiss’ Royal Oak home these days, Riley the bassett hound has learned that her owner’s lap is no longer hers.
The Kleisses continue to wait for any news they can on ALS — possible cures, treatment, a clinical trial that could involve Regis — “anything,” Mary Kleiss said.
Her son’s voice is gone, so his words are more carefully chosen these days. It’s tedious work: A reflective dot on Regis Kleiss’ forehead strikes the digital keys on a laptop screen in front of him as he twitches and turns his head to manipulate the words. “Y Me” he wrote, in April:
“It sucks to watch my body fai
l.
“While my mind n emotions r completely intact
“Knowing full well the end result
“And the road I’ll be forced to walk
“Becoming a prisoner in my own body
“Watching my world fly by
“Remembering how life used to be
“Missing so much of life.”
More Details: FOR HELP, INFO
• The ALS Association, based in Washington, advocates for ALS patients. Call 202-407-8580 or visit www.alsa.org.
• ALS of Michigan, based in Southfield, offers programs and services for ALS patients and their loved ones. Among the services are loans for medical and other equipment. Call 800-882-5764 or visit www .alsofmichigan.org .
• The U.S. Centers for Disease Control and Prevention operates a national registry to collect data from ALS patients to help scientists learn more about the disease. The registry and more information about the disease can be found at www.cdc.gov/als.
• The University of Michigan Health System is in Ann Arbor. Visit www.umich .edu and search for “ALS clinic.”
• The Harry J. Hoenselaar ALS Clinic is at Henry Ford Hospital in Detroit. Call 313-916-2835 or visit www.henryford .com/als.
• Mary Free Bed Rehabilitation Hospital is in Grand Rapids. Call 800-528-8989 or visit www .mary freebed.com and search for “ALS.”
COMING MONDAY
Researcher Dr. Eva Feldman campaigns to move ALS trials to U-M
U-M oversees cutting-edge trial that offers hope in fight against Lou Gehrig’s disease
By Robin Erb
Detroit Free Press Medical Writer
Full Story Online Click Here
Sometimes she glares at the painting of Jesus in her dining room.
“I just let it loose,” said Mary Kleiss at her Royal Oak home. “I look at that picture and I say, ‘You get down here and put on your boxing gloves and let’s get this over with.’ I am so damned angry.”
Her son, Regis, was diagnosed two and a half years ago with Lou Gehrig’s disease — amyotrophic lateral sclerosis, or ALS. It is, he writes, “as if God is torturing me.”
The disease kills with stunning efficiency — deadening its victims’ peripheral nerves, withering muscles and, in a final assault, shutting down their ability to breathe. An estimated 30,000 people have it at any given time; 5,000 are diagnosed yearly. Most die within years. There is no cure.
The disease has reduced Regis Kleiss, 28, a formerly thick-bodied shot and discus thrower and captain of the track team at Dondero High School, to a bony echo of himself. Paralyzed except for some minor movement of his head, he will spend his final days on a feeding tube.
ALS leaves its victims’ minds intact.
“It’s a miserable, damned disease,” his mother said.
Now, a clinical trial overseen by the University of Michigan may provide hope. It is cutting-edge and audacious work — the only ALS trial so far in which neural stem cells are injected directly into a patient’s spinal cord. So far, 15 patients have undergone the procedure — two of them twice — as the FDA monitors its safety.
One patient showed a remarkable improvement for a while, though U-M’s Dr. Eva Feldman, who heads the research, cautions not to read too much into that. The other 14 showed no improvement.
The trail is tentative and early. But when the rest of a person’s life has been compressed to an expectancy of two to five years, it is hope nonetheless.
The trial has been based in Atlanta since 2010, but U-M has requested approval from the U.S. Food and Drug Administration to expand it and move it to the University of Michigan in Ann Arbor.
The trial involves injecting 500,000-1 million stem cells into the spine. The ancestry of the cells 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.
Feldman and others theorize that these new cells act as nursemaids to damaged nerve cells, sending out repair signals, and somehow halting the progression of the disease.
The procedure worked in rats. It has been shown to be safe in pigs.
If the FDA approves moving the trial to Ann Arbor, Michigan patients will have access to an experimental treatment that not only might offer insight into a disease that kills an estimated 15 Americans a day, but also push back the battle lines against other neurodegenerative diseases, such as Parkinson’s and Alzheimer’s or Huntington’s.
“There is a lot of potential here,” said Sue Burstein-Kahn, executive director of ALS of Michigan, a Southfield-based nonprofit.
Last month, Feldman flew down with a team of U-M staff for the 17th surgery in the trial, in anticipation that the trial might soon move to Ann Arbor. The trial has been at Emory University in Atlanta since it began, in part, because Feldman wanted a former U-M neurosurgery resident, Dr. Nicholas Boulis, who is now at Emory, to perform the delicate procedure. Boulis collaborated with Feldman on her research for seven years during his residency.
Feldman is clear and she repeats this often: This part of the trial tests safety only. By design, it doesn’t
assess the efficacy of the treatment yet.
So the clinical trial patients so far — all from the Atlanta area — know the experimental stem cell therapy probably will not cure them. Still, they’re empowered, knowing their participation might one day cure others, said Ed Tessaro, a retired Macy’s executive, from his home overlooking a sparkling Georgian lake.
The following morning, Tessaro, 66, lay on an operating room table at Emory’s hospital, as doctors sliced through his skin and muscle, removed part of the bone in his spine and laid bare a pulsating, bright-white spinal cord for a second infusion of stem cells.
“It may kill us,” Tessaro said of the disease, “but it’s not going to defeat us before we die.”
Serving a greater purpose
It was 2008 when a single misstep and near-stumble during a half-marathon in Bangkok, Thailand, first worried Tessaro. It happened more than once. His muscles weakened, even as he stepped up his time at the gym.
Months later, a fresh, young doctor delivered the news to him and his wife, Judy.
They remember it well, even now.
“She said, ‘It’s the worst thing I could tell you,’ ” Judy Tessaro recalled.
” ‘You have ALS, and you have two to four years to live,’ ” Ed Tessaro added.
The doctor cried that day. So did Judy and Ed.
“The dynamics are pretty grim — fatal, no cure. Nobody has ever been cured. … It takes a while to get your head wrapped around that kind of reality,” Ed Tessaro said.
But Tessaro took stock. Life had been good, he decided.
Tessaro has been married for 43 years. He has a daughter and son and is a grandfather to two little girls. When he speaks of them, he can’t help but grin. And the pictures in the downstairs rec room at the Tessaros’ home are of a thrill-filled life: ice-climbing in New Zealand, marveling at the lush green of Vietnamese rice paddies, being stunned by the chase-and-dart flurry of a cheetah taking down a Thomson’s gazelle in the Serengeti.
Hiking. Biking. Skydiving.
He thought life couldn’t be more vivid. He was wrong.
Now, every conversation, every gentle touch from his wife, the babbling of his grandbabies — his senses are now in hyperdrive.
“In retrospect, I was living in analog. What I’m now living my life in is high-definition. … I’m living my life fully, because I know I have less of it,” Tessaro said.
When he heard about the clinical trial, Tessaro jumped at it, calling it “the larger-purpose stuff.”
“It’s not like I can hope for a miraculous reversal of this disease — it’s not coming,” he said. “I don’t think I have anything to lose … and I can be part of something bigger. It’s great therapy when you commit yourself to something bigger.”
He became Patient No.12 on April 13. Doctors slipped stem cells into the lower — or lumbar — section of his spine. The area that controls lower body movement, it was considered least risky because Tessaro was already losing the strength in his legs anyway. Clinical trial protocol limits risk.
Tessaro survived. In fact, he left the hospital days earlier than expected and felt better sooner than he expected.
So doctors decided — and the FDA approved — a second, riskier, surgery for Tessaro. This time, doctors would move to the upper — or cervical — portion of Tessaro’s spine, the area in which the nerves are responsible for breathing.
Feldman calls this area “precious real estate,” the stretch of spine where researchers say they believe the treatment may be most effective.
“Higher risk, but maybe higher reward,” Tessaro said, shrugging. He was in the pre-operating room of Emory University Hospital, surrounded by family and overnight bags and medical tubes and equipment.
It was July 20.
In a stretch of hallway and an elevator ride away, a nondescript FedEx box was being delivered to Dr. Jonathan Glass, director of the ALS clinic at Emory. His hands were working quickly.
Preparing for surgery
Glass pulled from the temperature-controlled container several vials of the stem cells known as NSI-566RSC. They had been thawed to about 39 degrees and then shipped overnight to Emory by Neuralstem, a Rockville, Md.-based biomedical company that is funding the trial, according to CEO and President Richard Garr.
The company has shelled out about $2.5 million for the first phase of the trial and provided the stem cells, one of the company’s premier products. They were drawn and cultured from the spine of an aborted fetus in 2000, then cultured again. They remain frozen until the day before they are ready for use.
They have arrived at Emory at 8 a.m. each surgery day of this trial — “never been late,” said Jane Bordeau, a research nurse and coordinator for the trial at Emory.
Glass separated out some of the liquid to test in separate vials, slipping some drops of blue liquid into the vials and tapping them lightly with a middle finger. He slid them onto a slide and rolled his chair to a microscope.
Dead cells will glow blue, he explained, having absorbed a dye that seeps inside their degrading membranes. Live cells remain clear and bright. At least 70% must be alive to be considered viable and to begin surgery, according to Neuralstem.
Glass began counting.
In an upstairs operating room, a red second hand circled a wall clock.
In the pre-op room, Tessaro had been discussing the 25 videos he planned to make for his toddler-age grandchildren. He knows ALS will steal his voice. So he will travel to the Smoky Mountains, set up a tripod and record for them stories, like how he met their grandmother.
He talked about the two books in his overnight bags, too: Hemingway’s “Farewell to Arms,” and — he added, laughing — “Fifty Shades of Grey,” because his daughter dared him.
Nearby, his wife was quiet. She fidgeted with an overnight bag.
In his lab, Glass punched some buttons on his cell phone calculator.
“It’s cool,” he announced. By his calculations, 83.6% of the cells had arrived alive.
It was time. The surgery would go as planned.
Surprising the doctors
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Ted Harada is on Page 8 of the March Journal of Stem Cells, which published the first study announcing the preliminary results of the first 12 patients.
Harada is the anomaly. Patient No. 11. Like Tessaro did last month, Harada this month will undergo a second surgery. And like with Tessaro, it took some time to diagnose the mysterious weakening of Harada’s body.
The former FedEx managing director, now 40, noticed he was getting winded in 2009 while playing Marco Polo in the family pool with his three children: “I’d go under water and come back up, and I was sucking for air.”
After a string of doctors — a family doctor, an orthopedist, a neurologist — the final diagnosis came in August 2010: ALS. The diagnosis was devastating, but the timing couldn’t have been better, the neurologist told him.
Clinical trial #NCT01348451 was under way.
By the time Harada, a self-described type A personality, went in for his surgery in March 2011, he was using a cane, unable to walk to the end of the driveway for the mail without losing his breath or to climb the 15 stairs to tuck his children in at night.
He saw the trial as a way to smirk at the disease, to become part of the solution that might one day beat it back for other patients, even if it didn’t do a thing for him: “I did the research, and I said to the doctors, ‘Yeah, I’ll be your guinea pig.’ ”
To his way of thinking, someone had to be the first man on the moon. Someone has to step up for medical research.
Plus, he added, “I know how the book ends if I do nothing.”
But what happened after his surgery wrote a chapter no one had expected.
The 14 other patients involved in the trial to date have shown no improvement; four have died — three from complications of ALS, and the other from a heart-related issue, according to Neuralstem.
In contrast, Harada put aside his cane soon after the surgery. And he was again tucking his children into their beds.
Feldman is insistent: Don’t read too much into Harada’s turnaround. The number of patients is tiny, and Ted is an oddity among them.
Still, Harada’s improvement, even if temporary, can’t be ignored.
The researchers have used several tests to measure patients’ outcomes, such as breathing capacity, the strength of their handgrip, and even the electrical impulses that flow through their muscles. There on these graphs is Harada, his dotted lines suddenly shooting upward after surgery.
In designing the clinical trial, “we were only aiming at stopping the disease,” said Dr. Karl Johe, chairman and chief scientific officer of Neuralstem. “But this is a patient that has clearly improved.”
Recently, Harada has begun to get winded again climbing the steps to his children’s bedrooms. He and wife, Michelle, 39, a sixth-grade teacher, have explained to their children that he probably won’t get better this time.
In her worst moments, Michelle has foreseen graduations and Christmases and grandchildren without him.
In their kitchen, the Haradas’ children had just finished slathering peanut butter on bread and disappeared upstairs. A deeply religious couple, the Haradas said they’ll take what they can get.
“We’ve been blessed,” he said.
Michelle Harada agreed, struggling against a surge of tears: “The surgery gave us two years back.”
Paving the way for others
Ed Tessaro was facedown, mostly draped in surgery blue in the crowded Emory operating room . It was 12:23 p.m. on July 20.
A stainless steel, crane-like contraption had been screwed into the cervical section of his spine. A steady beep-beep-beep of the monitors punctuated the hiss of a respirator. A digital camera recorded every movement for the FDA.
Standing just a few feet from Boulis, Glass was ready, with the spinal cord exposed.
It was 2:34 p.m. when Boulis asked for the cells.
For the next half hour, the vials were readied for the patented apparatus, on which an injection device slid along a guide to Tessaro’s spinal cord. It would inject 100,000 cells for each of five stops precisely 4 millimeters apart.
The target was the ventral horn of the spinal cord, a tiny area associated with motor neurons.
“Just looking at the spine can hurt it,” Glass had said earlier.
At 3:06 p.m., the injection device slid into place. A needle extended, injecting deep into the spinal cord and, for two minutes, the stem cells were forced into the ventral horn.
At 3:29 p.m., the fifth and final injection began, and two minutes later, the relief was palpable. From her viewing spot just a few yards from Tessaro’s neck, Feldman shifted on her feet and exhaled. The procedure, from start to finish, took a little more than six hours.
Technicians began to check recordings and run over the notes for the FDA. Boulis and the others began the process of removing the device and closing in the gaping hole in Tessaro’s back.
“Can we get some music in here?” Boulis said.
Whiz Khalifa’s rap filled the OR.
Feldman transferred the digital recording of the process to a memory stick she could review back at the office. A copy would go to the FDA, too.
There will be many more months of data, continued animal tests and most likely, hundreds of pages of reports.
Even if this early stage is proved safe and the clinical trial continues, doctors must figure out whether these are the stem cells that work best in this therapy, and, if so, in what amounts and injected into which areas. There’s the issue of the patients’ bodies rejecting these foreign bodies, too.
“This is not a small molecule pill, and your patients go … home and take the pill and you see them in your clinic in a few months,” said Steve Perrin, CEO of ALS Therapy Development Institute, a Massachusetts-based nonprofit focused on finding a treatment or cure for ALS. “These are the challenges this trial and this technology have in front of (them). They’re paving the road, because no one has been down this way before.”
On Friday, Tessaro was recuperating at home.
Waiting for any good news
In the Kleiss’ Royal Oak home these days, Riley the bassett hound has learned that her owner’s lap is no longer hers.
The Kleisses continue to wait for any news they can on ALS — possible cures, treatment, a clinical trial that could involve Regis — “anything,” Mary Kleiss said.
Her son’s voice is gone, so his words are more carefully chosen these days. It’s tedious work: A reflective dot on Regis Kleiss’ forehead strikes the digital keys on a laptop screen in front of him as he twitches and turns his head to manipulate the words. “Y Me” he wrote, in April:
“It sucks to watch my body fai
l.
“While my mind n emotions r completely intact
“Knowing full well the end result
“And the road I’ll be forced to walk
“Becoming a prisoner in my own body
“Watching my world fly by
“Remembering how life used to be
“Missing so much of life.”
More Details: FOR HELP, INFO
• The ALS Association, based in Washington, advocates for ALS patients. Call 202-407-8580 or visit www.alsa.org.
• ALS of Michigan, based in Southfield, offers programs and services for ALS patients and their loved ones. Among the services are loans for medical and other equipment. Call 800-882-5764 or visit www .alsofmichigan.org .
• The U.S. Centers for Disease Control and Prevention operates a national registry to collect data from ALS patients to help scientists learn more about the disease. The registry and more information about the disease can be found at www.cdc.gov/als.
• The University of Michigan Health System is in Ann Arbor. Visit www.umich .edu and search for “ALS clinic.”
• The Harry J. Hoenselaar ALS Clinic is at Henry Ford Hospital in Detroit. Call 313-916-2835 or visit www.henryford .com/als.
• Mary Free Bed Rehabilitation Hospital is in Grand Rapids. Call 800-528-8989 or visit www .mary freebed.com and search for “ALS.”
COMING MONDAY
Researcher Dr. Eva Feldman campaigns to move ALS trials to U-M.
* Goal: 50 states, 50 marathons
Goal: 50 states, 50 marathons
Cancer survivor checks off Vermont
8:50 AM, Jul 7, 2012
Written by JOHN A. FANTINO
Free Press Staff Writer
Diagnosed with an incurable blood cancer, Don Wright was told by doctors he had just a few years to live. That was nine years ago.
Since then, the 71-year-old from Lake Elmo, Minn., has run 63 marathons in 45 states, an impressive feat that he’s scheduled to continue Sunday when he runs the Mad Marathon in central Vermont.
“I’m not just surviving,” Wright said. “I’m thriving.”
Wright has multiple myeloma, a disease that attacks white blood cells and often comes with a death sentence.
“They said the average survival was five years,” Wright said. “You start getting your house in order pretty quick when you hear that.”
He also started cranking out training miles and marathon applications. For someone who started running when he was 61 simply to lose a few pounds, Wright soon completed his first marathon. Two weeks after being diagnosed with multiple myeloma, he qualified for the Boston Marathon.
Wright has been attempting to run a marathon in each of the 50 states, a mission he’s scheduled to complete this year.
The inspiring tour continues Sunday at the Mad Marathon, a 26-mile hilly trek through the Mad River Valley. The Mad Marathon, which debuted last year, starts and finishes in Waitsfield. The course snakes through rolling farmlands, quaint villages, dirt roads and covered bridges.
For Wright, each step of the race will represent success in his battle against cancer.
Opting not to undergo chemotherapy because it would make him too weak to train, Wright instead turned to the trial-drug pomalidomide several years ago.
“It’s just a pill,” Wright said. “I’d like to inspire the country to make available drugs like this for people who are dying. Accessibility to experimental drugs is important to me because it is saving me life.”
Wright, a lawyer, travels to many of the races with his wife Ardis and daughter Sarah, both of whom participate in half marathons while he runs the full marathons. They drive to many of the events, although they flew to Alaska last week to run a marathon.
What does Wright plan to do after running marathons in New Hampshire, New Mexico, West Virginia and Hawaii this year to complete the journey of 50 marathons in 50 states while fighting cancer?
“There’s a lot of Canada we haven’t explored yet,” he said.
To read the full article click here…
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R&D Changes Foreseen After Supreme Court Obamacare Decision
R&D Changes Foreseen After Supreme Court Obamacare Decision
http://www.genengnews.com/
Insight & Intelligence™ : Jul 5, 2012
Innovative drugs that offer clear superiority over existing products likely among beneficiaries of overhaul.
Alex Philippidis
By upholding President Barack Obama’s healthcare overhaul, the U.S. Supreme Court set the stage for several key changes to drug development, industry executives and observers agreed in interviews.
Craig A. Dionne, Ph.D., president and CEO of GenSpera, told GEN that biopharma startups won’t win the funding they need without showing investors solid results earlier in development. Those companies, he said, must offer investors clear evidence that their new drugs offer “clearly superior” efficacy than existing products, or else risk reduced reimbursement from government and private insurance programs under the Patient Protection and Affordable Care Act.
“We have to develop drugs that are very highly and clear differentiated in such a way that they can command premium pricing, and command reimbursement,” Dr. Dionne said. “In oncology, which is our world, that could be something as simple as no effect on the bone marrow, so you no longer need all those supportive cares and all those other expenses that come with a drug with that kind of side effect profile.”
“Companies won’t even get started unless they can start making that argument. And they’re not going to get continued funding unless they can make that argument for premium pricing in the future,” Dr. Dionne added.
Richard Garr, CEO of Neuralstem, told GEN the law will aid drug R&D through its extension of insurance to 32 million more people, and its prohibition on insurers rejecting patients for pre-existing conditions. The latter, he said, should help kickstart research and product development of genetic diagnostics, and for rare disease therapy developers like his company.
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“You can’t overstate the importance of this act with respect to the impact it will have on people saying, ‘If we think we have something that’s worth pursuing here on the science side, now we have a much higher comfort level on the business side also,” Garr said. “I would think you will see a flood of genomic companies and testing. I think people will be much more responsive than they ever had been to that, now that they don’t have to worry about their insurance being canceled because they know.”
The healthcare law incorporated the Biologics Price Competition and Innovation (BPCI) Act of 2009, which mandates creation of an abbreviated approval pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed biological reference product.
Among companies interested in BPCI are Quintessence Biosciences, a developer of anti-cancer, protein-based therapeutics.
Laura E. Strong, Ph.D., Quintessence’s president and COO, told GEN BPCI’s 12-year data exclusivity period is especially welcome by her company, which envisions itself a reference drug developer for future biosimilars.
“One of the issues that’s really important when you think about investment in innovation in biotech and pharma is, What’s the return on investment going to be? Having a more certain marketplace is definitely an improvement,” Dr. Strong said.
Action on biosimilars, however, will have to await FDA approval of final guidances for implementing BPCI; the agency issued three draft guidances on February 9.
FDA isn’t the only Washington hurdle for biosimilars. Obama’s administration wants to shrink exclusivity to seven years, claiming it would save $4 billion over 10 years; Congressional committees have sided with industry. “Our expectation is that the administration would continue those efforts, and we believe that would be certainly problematic,” Todd Gillenwater, svp, public policy with the California Healthcare Institute, told GEN.
He said industry will also continue fighting the law’s Independent Payment Advisory Board focused on cutting Medicaid costs. Biopharma groups say quality of care would be sacrificed, adding the board of 15 unelected presidential appointees requires more oversight.
Industry is also waiting for the states to establish the law’s insurance exchanges. “States continue to feel a lot of budgetary pressure, and there are other factors that may contribute to them not being able to move forward as quickly as they’d like with implementation,” Christie Bloomquist, a partner in the Washington, D.C., office of Hogan Lovells, told GEN. One such factor surfaced in recent days, as officials in Iowa, Louisiana, Mississippi, South Carolina, Texas, and Wisconsin said they may join Florida, where Gov. Rick Scott said Sunday he would not permit Medicaid expansion. All seven states are led by Republicans.
While biopharmas chafe at some provisions, industry mostly favors the healthcare overhaul. But to see the biggest benefit, companies will have to balance their desire to grow their pipelines and advance drugs with the law’s likely reality that investors will limit already-scarce dollars to treatments showing the best results.
Another Twist on ADCs
Another Twist on ADCs
Researchers at Johns Hopkins University have developed a new twist on antibody-drug-conjugates (ADCs): a drug related to the plant poison thapsigargin, coupled to a peptide that binds to prostate-specific membrane antigen (PSMA), which is not really prostate-specific, but instead is expressed on endothelial cells in the microenvironment of many solid tumors. Thapsigargin is a poison that inhibits SERCA, a calcium pump which is critical for cells to maintain their membrane potential. Untargeted, the drug is far too toxic to use medically. But you can slow levitra price down this change by leading a stress free life and taking an anti-impotency drug. Drink plentiful water discount buy viagra and reduced the amount of sodium you take all through the day. Normal atmospheric pressure (14.7psi at sea level) outside the cylinder and near the pubic bone area will force blood to rush in to satisfy the differences between that pressure and the one inside the cylinder. buy cialis no prescription Thus by using this medication every man will be able to knock off impotence from their life. online cialis But the authors showed that by combining it with the PSMA targeting peptide, they were able to make a prodrug, G202, which achieved “substantial tumor regression against a panel of human cancer xenografts in vivo at doses that were minimally toxic to the host.” These results appeared in the June 28, 2012, issue of Science Translational Medicine. G202 is being developed by GenSpera Inc. The drug is currently in Phase I trials.
See the reprint click here…
* Man With Cancer Chases 50-In-50 Marathon Goal In Alaska
Man With Cancer Chases 50-In-50 Marathon Goal In Alaska
Kevins Wells has the story of a man who is battling cancer mile-by-mile and state-by-stat…
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Go to this link and click on the video. “Man with Cancer. . . .”
* Mayor’s Marathon Taking Place This Weekend
http://www.alaskapublic.org/
Mayor’s Marathon Taking Place This Weekend
Even no other High Quality Acai is good enough for the purposes they are intended for. (CRI-report) -Diabetes refers to a series of metabolic disorder syndrome such as sugars, proteins, fat, water and electrolyte that are triggered by islet dysfunction and insulin resistance, and high plasma acute phase protein levels for patients of ED. order cheap viagra Right now you need to be questioning what is pde5 and so how exactly does cheap cialis professional in erections by inhibiting pde5. Although there are 20 types tadalafil india of hoodia, only the hoodia gordonii variety is believed to contain the natural appetite suppressant. online viagra prescription It has a big impact on a man’s poignant well-being. By Wendi Jonassen, APRN – Anchorage | June 22, 2012 – 4:53 pm
The 39th Mayor’s Marathon held near summer solstice every year attracts thousands of visitors to Anchorage. This Saturday the organizers of the road race expect 4,300 runners to tackle the course through Anchorage, including one man with an extraordinary story.
* 71 Year Old Cancer Survivor Don Wright Has A Goal Of Running A Marathon In All 50 States
Read the full story and see video by clicking here.
71 Year Old Cancer Survivor Don Wright Has A Goal Of Running A Marathon In All 50 States
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71 year old cancer survivor Don Wright has a goal of running a marathon in all 50 states. So far he’s run in 44 states and he’ll make it 45 states next Saturday when he runs a marathon in Anchorage, Alaska. He runs for two charities Team Continuum and Tackle Cancer. Photojournalist John Gross has his story. To watch it click on the video box above.
Give hope to those with ALS
THE ATLANTA JOURNAL CONSTITUTION
Give hope to those with ALS
http://www.ajc.com/opinion/give-hope-to-those-1431799.html
By Ted Harada
8:02 p.m. Friday, May 4, 2012
I have a lot to live for: a beautiful family, friends and a life I love. Until a few short years ago, I also had hope.
All that changed in an instant. My future, my career, my hope of watching my three children grow up, attending their graduations, walking my daughters down the aisle, holding my grandchildren and growing old with my wife — all of that disappeared with two short sentences: “I’m sorry, you have ALS. There is no cure.”
However, you must know that the Internet store offers an encrypted checkout such tadalafil samples as VISA card payment. Besides, understanding your partner’s needs and cordial sale generic tadalafil communication with her should also help you a lot. As an herbal male impotence treatment the capsule is rated as one of the best herbal cheap cialis supplements for your drugs, you might be surprised to acknowledge that you will get that health care within way less in contrast to the 50 percent of the cost of Kamagra . Also, cheap Kamagra, which is cheap female viagra similar to a great extent. In 2010, I was diagnosed with ALS, or Lou Gehrig’s disease. I was 38. My left leg fatigued easily. I was short of breath, my energy tapped. I needed a cane to walk. Then came the barrage of tests, the results the same: There is no hope. You are without hope.
Then I heard about a clinical trial transplanting neural stem cells into the spinal cords of ALS patients. It was the first of its kind. The Food and Drug Administration approved it and I qualified. I was treated at Emory University Hospital in March 2011.
Since then, the deterioration from ALS has temporarily slowed. I even completed a 2 1/2-mile walk to defeat ALS. What a change. This is real progress. I have hope again. But it’s not enough. We need to have hope for everyone.
I am doing everything I can to focus research on a cure for ALS and other diseases. I have become a speaker, finding a new voice as my leg strength returned. I work with ALS Treat Us Now, a nonprofit dedicated to saving the lives of patients by gaining them access to potentially lifesaving drugs. We must also support organizations that are leading the charge with breakthrough treatments, such as Neuralstem Inc., the sponsor of the Emory trial.
And that’s not enough.
The FDA needs to speed approvals and encourage the research necessary to make meaningful progress. Two new recently introduced pieces of legislation would allow the FDA to move faster in approving therapies for life-threatening diseases. The Advancing Breakthrough Therapies for Patients Act, introduced by Sens. Michael Bennet (D-Colo.), Orrin Hatch (R-Utah) and Richard Burr (R-N.C.), and the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act, introduced by Sen. Kay Hagan (D-N.C.), would expedite development of new treatments and speed up the FDA approval process for patients who can’t afford to wait.
I have new hope that America’s best scientists will create breakthroughs. But we need to remove bureaucratic obstacles that also discourage biotech investors. According to James Greenwood, president of the Biotechnology Industry Organization, “61 percent of venture capitalists now cite FDA regulatory challenges as having the highest impact on their investment decisions, and 40 percent expect to decrease their investment in the development of new therapies.”
Hope is something that is meant to be shared. Those of us who can speak out must urge Congress to join us and pass these critical pieces of legislation. Hope is out there. We just need to make it real.
Ted Harada, a former manager for FedEx and DHL, is on the board of directors of the Georgia ALS Association. He lives in McDonough.