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Washington area business diary for week of Jan. 2

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Short takes on the week’s announcements and deals.

Pharmaceuticals

Rockville-based Neuralstem has received approval from the Food and Drug Administration to advance to Phase Ib in its ongoing clinical trial to test its neuroregenerative compound NSI-189 for the treatment of major depressive disorder.

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* A Miracle Drug Keeps This 70-Year-Old Cancer Patient Running Marathons

Don Still Going

http://gizmodo.com/5867859/a-miracle-drug-keeps-this-70+year+old-cance

Don Wright was diagnosed with myeloma—cancer in his blood cells and bone marrow—two weeks after running his first marathon. His doctor gave him a five-year survival estimate. Eight years later he has run 60 26.2-mile races in 41 states and takes just one pill per day to keep his cancer at bay.

“I feel wonderful,” Wright says. He and his family run the races together: his wife and daughter run half marathons while he does the whole shebang. His only complaint is a touch of runner’s knee every now and then.

Wright’s miracle drug is called pomalidomide, and it’s still in clinical trials. It’s one of several emerging therapies over the past decade that have doctors stunned and cautiously ecstatic about their effectiveness. Other drugs in this group include thalidomide (infamous for causing birth defects in the 60s) and lenalidomide, which are called immunomodulating agents. While not a cure, they could make treating cancer as relatively manageable as taking insulin for diabetes or a statin for high cholesterol.

Dr. Brian Durie, the co-founder and chairman of the International Myeloma Foundation, is amazed by Wright’s running stamina. “It’s mind boggling, for God’s sake. It’s amazing.”

The key, he says, is to stay on the treatment, just like taking insulin regularly to keep diabetes at bay. It’s a major and welcome shift from the comparatively shorter but heavy-hitting and damaging doses of chemotherapy and radiation that were the baseline treatments for myeloma 10 years ago. Most patients will take a lifetime of taking one pill per day over months of hair loss and severe nausea.

It helps in burning calories and improves the blood flow to the organ. levitra pills from canada slovak-republic.org for sale viagra In the majority of cases, the problem is due to erectile dysfunction. There are studies that show that cialis overnight far lesser side effects than its counterparts, lasts longer and is not proper. The increasing stress and improper diet causes discount generic cialis to produce some hormonal disorders in the body like diabetic problems. “These molecules are multifunctional,” Dr. Durie says. “They shut down pathways in the cancer cells and the micro-environment in the bone marrow.”

Nowadays, most newly-diagnosed patients try one of these novel drugs since they work so well for some people. The problem is, the treatments are unpredictable and work differently for everyone. That’s why Dr. Durie and his colleagues are taking samples of patients’ bone marrow and using genetic profiling to determine who will respond best to which drug.

First we sequence the whole genome, then we break it up into smaller sequences about 200 nucleotides long. Then you sequence those, and you end up with literally millions of these little pieces. You line those up and compare the malignant cells with the normal cells.

By comparing these super-detailed sequences of DNA, Durie hopes to one day determine who will respond best to each drug on the list of novel treatments for myeloma.

Meanwhile, Wright hopes to keep taking pomalidomide for as long as it keeps working for him. At 70, he’s beginning to slow down, but only slightly. His goal is to run a marathon in every state—he’ll rack up one more this weekend in Rehoboth Beach, Delaware. He has already won multiple marathons in his age group, his fastest race being 3:36. That’s twice as fast as my fastest marathon, which I ran when I was half Wright’s age. Clearly he loves running more than I ever did:

“I just cruise,” he says. “I coast.”

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* Clinical depression doesn’t go away when the holiday season ends

Clinical depression doesn’t go away when the holiday season ends

Posted: 12/12/2011 01:00:00 AM MST
Updated: 12/12/2011 05:06:05 PM MST

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By Sheba R. Wheeler
The Denver Post

Feeling blue? Seasonal sadness is fairly common, but clinical depression lasts beyond the holidays. (Jupiter Images)

This time of the year, you’d better be jolly … or else.

It seems like the unceasing celebrations began with the first bite of Thanksgiving turkey and won’t stop until the kiss on New Year’s Eve.

So why do so many people dread the winter season, muddle through the holidays, or feel isolated, sad or stressed when everybody else seems happy? And how do you know if what you are feeling is just the holiday blues or something more serious, such as clinical depression?

The key indicators are the duration and severity of the symptoms and whether they interfere with daily function, says Dr. Eugene DuBoff, assistant medical director at Radiant Research in Denver, which is conducting clinical trials on new antidepressants

The seasonal blues come and go but aren’t persistent and will clear up shortly after the holidays go away. A person won’t be magically happy, but will return to how he or she was feeling a few months prior, says DuBoff.

But clinical depression simultaneously affects the mind and body. Symptoms include loss of interest, feelings of guilt and inadequacy, a significant loss of energy, sleeping too much or too little, or eating too much or too little.

A depressed person has trouble concentrating. And symptoms will last for weeks on end, seriously hinder personal relationships and make it difficult to function at work or school, DuBoff says. He is recruiting patients for a clinical trial to evaluate amitifadine, a new medication for major depression that acts on three chemicals in the brain without the weight gain and decrease in sexual function often associated with other treatments.

“It’s important for people to know that many, many people feel a sense of sadness, loss and some depression during the holidays,” says DuBoff. “But the differences between the holiday blues and clinical depression are vast and based on duration, severity and interference with daily functioning. Imagine the difference between pancake batter versus molasses. Depression is all-consuming, and it drags you down.”

On top of the normal seasonal stresses on finances and time, the poor economy and job losses continue to plague many who are struggling to make their mortgages, utilities and car payments.

“People come into my office to talk about health issues when they are in fact suffering from anxiety and depression,” says Dr. Linda Petter, a family-practice physician in Tacoma, Wash. “I’m seeing people relapse and have depression symptoms that come back because of the combination of seasonal stress and the financial impact. Many people still don’t have a job and are really struggling.”

Some report feeling “blue,” “down in the dumps” or “out of sorts” because they are overwhelmed from gift buying and socializing. They dodge party invitations. Some are grieving loved ones lost, from romantic partners to parents or siblings who have died.

As Virginia Basye Carr’s children grew older and moved away from home, she said she realized holiday celebrations would never be the same. Getting divorced, exchanging her family home for a one-bedroom apartment and replacing a 6-foot Christmas tree cluttered with gifts with a 3-foot mini brought on holiday blues.

Now a Christian counselor, Carr wrote “Change the Way You Think,” released in November by Ambassador International. The Bible-based book offers readers tips on controlling their moods by being mindful of their thoughts.

Carr’s blues progressed into depression when she lost a job she loved. She felt hopeless and helpless. She lost interest in things that used to soothe and no friends could console her. Thoughts of suicide “were my constant companion,” Carr says.

“Any time someone is contemplating harming themselves, that’s not the blues anymore,” says Joan Hummel, a bereavement counselor for Porter and St. Anthony Hospice in Denver. “That kicks them into clinical depression, and they need to seek help immediately.”

How to handle the holidays

Whether someone is coping with a seasonal mood disturbance or clinical depression, both are treatable, and people can get better and recover, says Petter, the family doctor who also hosts a radio show.

Jaime Vinck, clinical director at Journey Healing Centers, drug and alcohol rehab programs in Arizona and Utah, suggests:

• Avoid alcohol, which will exacerbate any situational depression during consumption and the day after intake.

• Watch food intake. Sugar binges can create feelings of lethargy and crashes that mimic depression.

• Stay in the moment. Avoid thinking about the past or worrying about the future. True peace is found in the here and now.

• Pay attention to your feelings of sadness, and use them to make changes in the new year.

Is it depression?

If you are experiencing five or more of these warning signs every day for at least two weeks, see a doctor — it could be clinical depression:

• Suicidal thoughts: Unlike other symptoms that may be indicators of other conditions, this is the No. 1 sign of depression and calls for immediate treatment.

• Overeating or lack of appetite

• Fatigue

• Insomnia or sleeping too much

• Inability to concentrate

• Destructive risk taking

• Lack of interest in activities

• Low self-esteem and insecurity

• Irritability

• Impatience

• Poor judgment

• Obsessive thoughts

If it’s holiday doldrums

“If you try these tips and after a few weeks you aren’t seeing improvement, then go see a doctor,” says Virginia Basye Carr, counselor and author of “Change the Way You Think.” “But these can really make a difference for many people and turn their holiday around.”

Try over-the-counter remedies including St. John’s wort.

Take an omega 3 fatty acid supplmentfrom 2,000 to 4,000 miligrams a day. Or add more walnuts, soybeans, flaxseeds or fish to your diet.

Increase your vitamin D intake to 1,000 to 2,000 IUs daily. Or get a lightbox if exposure to sunshine is limited. The light mimics sunlight and can cause a biochemical change that lifts mood.

Pace yourself. Make a list, and don’t try to get everything done in one day.

Focusing on the basics can help control mood.Adults should get seven to nine hours of uninterrupted sleep nightly so the brain can relax, function better the next day and better handle daily stressors.

Do not skip meals. The body and brain need fuel to function properly.

Do aerobic exercises at least 30 minutes five to seven days a week. A workout dissipates stress, and it helps you think more clearly and sleep soundly.

Learn how to and when it’s appropriate to say “no,” to limit daily stressors.

Spend 30 minutes doing something you love (other than exercise). Giving back to yourself renews energy.

Posted on

* Human Factor: Running marathons while fighting cancer at 70

Click on the link below to view the video
http://www.cnn.com/video/#/video/health/2011/11/29/hf-don-wright-marathon.cnn
November 29, 2011

Human Factor: Running marathons while fighting cancer at 70

In the Human Factor, we profile survivors who have overcome the odds. Confronting a life obstacle – injury, illness or other hardship –- they tapped their inner strength and found resilience they didn’t know they possessed. This week we meet Don Wright, who developed a passion for running marathons later in life, right before getting diagnosed with cancer. His goal is to run 50 marathons in 50 states.

“I’ve made an appointment with an oncologist for you.” These are words that no one wants to hear from their doctor, ever. It was multiple myeloma, an incurable blood cancer with a median survival of about five years after diagnosis.

I had lost weight at Weight Watchers’, then started running, and had just run my first marathon. Myeloma attacks the bones, and a broken bone would stop my running, so I was determined to run the Boston Marathon before I lost the ability to do so. I qualified for Boston and then ran it, then a few more marathons here and there. I had no reasonable expectation of finishing all 50 states.

That was eight years ago. I’m now 70 years old and since the diagnosis I have run 60 marathons in 41 different states, including the Seattle Marathon last Sunday. After some treatments that didn’t stop it, the cancer has been stable for three and a half years on a novel investigational drug called pomalidomide, just a pill that I take once a day. I’m a beneficiary of modern innovation and research.

I have this incurable cancer, and my most pressing health problem is runners’ knee!
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My doctors are uniformly enthusiastic about the running as a way to strengthen my immune system and my bones. “We’re not sure why it works, but keep doing what you’re doing.”

We can’t know how long this treatment will continue to keep the cancer from growing, but for now, my family and I are relishing the extra time that I have been given, by traveling and doing these marathons together. They are a celebration of life!

I stand at the starting line and get choked up, thinking of the people I know who haven’t survived myeloma, and how lucky I am to be alive and able to run a marathon. I can’t wait to start the race. Even on a cold, rainy day in Seattle, I enjoyed every moment. As I run, I sometimes imagine that I’m just floating along, drifting past the scenery. I feel wonderful, and we’re going for all 50 states.

Since August I have also been running on behalf of Team Continuum, a charity started by a man with myeloma. It helps patients and their families meet their daily expenses while fighting cancer. Here’s how you can help:

– Click “like” on this Facebook page and a donor will contribute $5.00 at no cost to you: facebook.com/ERACECANCER.

– Go here if you would like to make your own donation directly to
TeamContinuum.net.

With my cancer I am very lucky to be able to run marathons, and I feel even more privileged to run them on behalf of other cancer patients.

Posted on

* Cancer patient runs marathons

Cancer patient runs marathons

Sanjay Gupta MD|Added on November 28, 2011

Dr. Sanjay Gupta talks to a cancer patient whose goal is to run a marathon in every state.
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http://www.cnn.com/video/#/video/health/2011/11/29/hf-don-wright-marathon.cnn

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Operation marks another step forward in stem cell research

Operation marks another step forward in stem cell research

http://www.cnn.com/2011/11/21/health/stem-cells-als/index.html?iref=allsearch

By Miriam Falco, CNN

updated 3:00 PM EST, Mon November 21, 2011

STORY HIGHLIGHTS

  • For the first time, stem cells are injected into the spinal cord in the neck
  • It is part of a trial to see if the procedure can be safely done
  • “I feel like we finally arrived,” says the surgeon who invented a key structure

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Atlanta (CNN) — A 50-year-old man from Trion, Georgia, is the first person to be injected with stem cells in the upper part of the spinal cord, making him yet another pioneer in the scientific quest to use stem cells to heal.

Richard Grosjean received the treatment Friday. He is part of an ongoing FDA-approved clinical trial that is testing the safety of injecting stem cells into the spinal cords of patients with amyotrophic lateral sclerosis, or ALS, also known as Lou Gehrig’s disease.

Grosjean was diagnosed a little over two years ago, his wife, Tracie, told CNN. He can still walk with a cane, but he has a lot of weakness on his left side and has trouble with his speech.

“I’m pretty much his voice for him,” Tracie Grosjean said.

Through his wife, Grosjean says “he has 100% confidence in Emory and Dr. (Jonathan) Glass and Dr. (Nicholas) Boulis and the good Lord that good things will come” from the trial.

While the Grosjeans know this procedure is likely to be more helpful to others in the future who have to deal with this “horrible disease,” they have hope and faith that some good will come of this for them, too. In addition to praising Emory University, Tracie also praises her husband’s employer, Mount Vernon Mills, which she says has “bent over backwards” to keep him employed throughout his illness giving him a sense of purpose.

The cause of ALS is unknown, but the disease is fatal because nerve cells, or neurons, in the brain and spinal cord needed to tell muscles to move, waste away or die. Early in the disease, patients have difficulty speaking and walking, both symptoms Grosjean now has. Eventually, the disease cuts off communication between the brain and chest muscles, so patients can no longer breathe.

Most people die from respiratory failure, according the National Institutes of Health, and most patients die within three to five years of diagnosis.

The team of researchers in this clinical trial is headed by University of Michigan neurologist Dr. Eva Feldman, who designed the trial; neurologist Glass, who is in charge of the clinical trial at Emory University in Atlanta, where patients are getting the injections; and Emory neurosurgeon Boulis, who invented the structure used to safely inject the stem cells into the patient.

In an operation than lasted about four hours, Grosjean received five injections into the cervical, or neck, area of his spinal cord, each delivering 100,000 cells. The cells came from Maryland-based biotech company Neuralstem, which is funding this clinical trial and devised a procedure to grow millions and millions of motor neuron cells from the donated spinal cord tissue of an 8-week-old aborted fetus.

These are not embryonic stem cells, like the ones used by California-based company Geron, which has injected cells grown from human embryonic stem cells into the spines of at least four patients with complete spinal cord injuries.

Embryonic stem cells have the ability to become any type of cell in the body. One week ago, Geron decided to stop their trial because it was too expensive to continue.

The cells in this ALS trial were taken from the spinal cord of the fetus, so they have already gone down the path of becoming nerve cells. Researchers are hoping to show that injecting neural stem cells — the precursors to nerve cells — into the spinal cord of ALS patients is safe.

Ultimately, the hope is that by injecting the cells into the neck, above the lungs, where the mostly deadly damage is done by ALS, these neural stem cells will reconnect communication from the brain to the muscles, keeping patients alive longer and maybe, one day, curing them.

But that is not the point of the trial at this time. At this point the goal is still to establish that injecting stem cells is safe for the patient, won’t cause more damage to the patient, and won’t lead to the patient reject the cells. Early data from the first 12 patients, who had injections in the lower back, shows this procedure is safe.

Injecting anything into the spinal cord is very dangerous because it can cause serious damage. To avoid injuring the spinal cord, which is always moving as the patient breathes, the needle delivering the stem cells has to move along with the body.

Boulis invented an apparatus that resembles a miniature oil rig mounted on to the patient’s spine. It moves with every breath and holds a super-fine needle through which to inject the stem cells. To prepare for these surgeries, Boulis and his fellow surgeons practiced mounting the apparatus on pigs, which are close in size to humans.

The first 12 patients in this clinical trial had the “rig” mounted on their lower back, giving surgeons a flatter surface to work with.

But the injection site on Grosjean is on the neck, posing a new challenge for Boulis.

“It didn’t fit exactly as I had envisioned it,” he said immediately after the surgery. “In fact, I ended up applying it much in the same way that I had applied it in pigs, as opposed to how I had envisioned it in humans, and that gave us nice solid fixation.”

Boulis screwed the structure to the spine on one side, but to the skull on the other side.

With the spinal cord exposed after removing part the spine and peeling back layers of muscle and membranes protecting the cord, the injections slowly began. They have to be slow — injecting the cells too fast alone can damage the cord or the cells can spill out, never having a chance to nestle into the spinal cord.

After the third injection went smoothly, Boulis paused to note what they were accomplishing at this moment. After the surgery he said, “it is a big milestone for us. … I think the biggest thing about this is that I feel like we finally arrived.”

That’s because Boulis and his colleagues have come a long way, through trial design; to testing the cells in mice to ensure they don’t cause tumors, which sometimes happens with stem cells; to inventing the needle-holding oil-rig-like apparatus; to practicing on many pigs; to perfecting how attach the device to patients.

“Finally we’re beginning to inject cells into the segments that control the diaphragm, and to the extent that we are able to do that safely … this is where we keep people breathing,” Boulis said.

And that’s ultimately what this clinical trial is about.

Glass described Friday’s surgery as being at the beginning of crossing an important threshold. “I think it’s a huge step forward. I don’t want anyone to think that we have a cure for this disease. We don’t. But we now have a whole other way to approach it, and that’s really what’s exciting and important.”

Feldman described the day as the most momentous in their pursuit of using stem cells in the treatment of ALS.

“I have spent over 25 years taking care of patients with ALS, and I feel today I can go back to them and give them hope,” she said.

Alan Trounson, president of the California Institute for Regenerative Medicine in San Francisco, agrees, calling the progress in this clinical trial a “big step forward.”

Every clinical trial that can show a stem cell procedure to be safe is important, he said.

“These are tough diseases,” Trounson said. He agreed that being able to safely inject stem cells into the cervical area of the spinal cord is an important step forward for patients with ALS and potentially other neurodegenerative diseases such as multiple sclerosis.

Grosjean, Glass and Boulis are quick to point out that they have to replicate this surgery in other patients. Two more patients will receive the same cell dosages in the near future in this part of the clinical trial.

After telling Tracie Grosjean how well the surgery went, Glass was excited and cautiously optimistic.

“We’re moving forward,” he said. “We don’t have a treatment yet, we don’t have cure yet and there’s no evidence yet even putting these stem cells on the spinal cord is going to either slow the disease or prevent progression or even make it better.”

Three days after the surgery, Boulis said the patient was doing well. Neurologically he is where he was before the surgery. His legs and arms are moving, confirming what was monitored throughout the entire surgery. The spinal cord was not damaged.

Tracie Grosjean said her husband is still in pain, which doctors say is expected given the surgery. But she said the doctors tell them he’s doing great and they hope be home in time for Thanksgiving.

© 2011 Cable News Network. Turner Broadcasting System, Inc. All Rights Reserved.

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After Geron, Stem Cells’ New Saviors

Newsweek

http://www.thedailybeast.com/articles/2011/11/18/after-geron-stem-cells-new-saviors.html

After Geron, Stem Cells’ New Saviors

The biotech Geron may have abandoned its famous effort to treat paralyzed patients with stem cells—but two rivals are swooping in to do groundbreaking trials, Sharon Begley reports. So far, their results are even more promising.

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When the biotech company Geron announced this week that it was halting its pioneering stem-cell program—whose centerpiece is a clinical trial in which four paralyzed patients with spinal-cord injuries were injected with cells derived from embryonic stem cells—the chief scientist at a rival firm had one thought: “I guess that leaves us holding the flag,” Robert Lanza of Advanced Cell Technology told me. “There’s a lot of weight on us to deliver now.”

The Geron study was famous for being the first to treat patients with cells taken from human embryos, and its premature end, due to financial concerns, may seem like a disappointing finale. Fortunately, at least two lesser-known firms are swooping in to continue similar groundbreaking research—perhaps with even more promise and practical applications—and with the potential to revolutionize medicine. One is forging ahead with an extraordinary new test today.

The better known of the two, ACT, has the only other Food and Drug Administration–approved clinical trials using embryonic stem cells, as Newsweek recently described: one trial is for patients with Stargardt’s macular dystrophy and one is for age-related macular degeneration. Both diseases cause blindness. (The studies are notable because Catholic nuns are among the patients, even though the Vatican has condemned stem-cell research.)

stem-cells-begley
Ted Harada, stem-cell patient

But there’s also Neuralstem Inc., which is in the midst of a clinical trial for ALS (amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease). Today, if all goes as planned, 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.

In ALS, motor neurons in the spinal cord and brain deteriorate to the point where, eventually, they can no longer signal muscles to move. As a result, patients become paralyzed and, when motor neurons controlling respiration die, unable to breathe; most die within three to five years of diagnosis, and only one quarter survive at least five years. There’s currently neither a treatment nor a cure for ALS.

Neuralstem, based in Rockville, Md., uses cells slightly older than the days-old embryonic stem cells Geron used, opting for “neural” stem cells. Unlike embryonic stem cells, which can differentiate into the 200-plus kinds of human cells, neural stem cells have already chosen their fate; they can become any of three kinds of cells in the central nervous system (neurons, astrocytes, or oligodendrocytes). Neuralstem obtained all the cells it has needed so far from an eight-week old fetus that was aborted in 2000.

The procedure has been attempted on 12 ALS patients so far, starting in January 2010. They received either five or 10 injections of 500,000 or 1 million neural stem cells, respectively, into the lower (lumbar) region of the spine, in a procedure developed and performed by neurosurgeon Nicholas Boulis of Emory University, under the direction of Emory neurologist Jonathan Glass. The patient lies on his belly, and Boulis makes an incision and removes two layers of bone covering the cable of nerves that is the spinal cord. Then, guided by an MRI that shows where the motor neurons are, Boulis injects the stem cells, which takes about two minutes.

Although the goal of this early trial is to determine whether the procedure is safe—which it seems to be, although two patients have since died of ALS—the scientists have also seen hints that the cells benefit the patients. Ted Harada, 39, was a manager at Shred-It, a mobile shredding service based near Atlanta, when he was diagnosed with ALS in 2010, and by the time he enrolled in the study he was able to walk only with the help of a cane. Climbing stairs was difficult, he recalls, and he was easily fatigued and often out of breath. He was unable to raise his left leg while sitting if someone pressed on it even lightly, and his left arm was also losing strength.

Since receiving 10 stem-cell injections last March, Harada has improved enough to complete Atlanta’s two-and-a-half mile Walk to Defeat ALS on Oct. 22. “I still have ALS, but I’m starting to see signs of hope,” said Harada.

Studies of lab animals suggest how the neural stem cells might be benefiting Harada and other patients. The cells remain where they are injected in the spine, says Karl Johe, chief scientific officer of Neuralstem, right beside a high concentration of the motor neurons that are being killed by ALS. There, although the stem cells cannot resurrect dead motor neurons, they can keep additional ones from dying, explains Johe: they produce protective molecules.

Protecting neurons only keeps ALS from getting worse, however—they don’t reverse it. One reason Harada regained movement and strength might have been that the injected stem cells also cause axons—the long tails on neurons that connect neuron to neuron as well as to muscle—to regrow. “The connection that the motor neuron makes to the muscle is the first thing that goes in ALS,” explained Glass, possibly because the neuron becomes too weak to support the long axon that connects to the muscle. “It might be that if you can rescue the cell body [with neural stem cells], you can rescue that connection,” said Glass.

Animal studies suggested just that, said Eva Feldman, director of the A. Alfred Taubman Medical Research Institute at the University of Michigan and an unpaid adviser to Neuralstem: “You can hypothesize that if the nerve cell is just about to give up the ghost, the stem cells preserve it and the axonal connection is restored, with the result that the patient has a restoration of function.”

Today, for the first time, Boulis is scheduled to inject neural stem cells not into the lower part of his patient’s spinal cord, to restore movement in the legs, but into the upper region, to target motor neurons that control respiration.

Neuralstem believes that neural stem cells could also treat spinal-cord injury—the condition Geron targeted—and Huntington’s disease, in which neurons in the brain are killed much as they are in ALS. The company has requested FDA permission to launch a spinal-cord injury trial.

‘Many of us were surprised Geron selected spinal-cord injury in the first place,’ said Lanza. ‘It didn’t really make a lot of sense, either commercially or biologically.’

ACT, too, “remains committed to embryonic stem2cell research,” said Lanza. “We have no intention of letting [Geron’s decision] interfere with our mission.” The company’s clinical trial, at UCLA, uses what are called retinal pigment epithelial cells, grown from embryonic stem cells, to treat two causes of blindness, Stargardt’s disease and macular degeneration. (Stem cells from a human embryo are grown in the lab, and after they differentiate into the kind of cell needed for the disease being targeted, they’re injected into patients.) “We’re moving full steam ahead,” said Lanza, making final arrangements for other sites to enroll patients. Although results have not been formally reported yet, the first patients—who received stem cell–derived treatment this summer—are doing well enough, Lanza said, that “both want us to treat their other eye.”

In contrast, it would have taken years for Geron to see whether the cells it had derived from embryonic stem cells helped spinal-cord patients regain movement. “Many of us were surprised Geron selected spinal-cord injury in the first place,” said Lanza. “It didn’t really make a lot of sense, either commercially or biologically. So it’s not too surprising they didn’t obtain any biological effect. Although treating spinal-cord injury has a kind of sex appeal, you have to take reality into account, including not only the market but the chances of success.”

 

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Could This Be the End of Embryonic Stem Cell Research?

Could This Be the End of Embryonic Stem Cell Research?

By Kristen Philipkoski

Nov 15, 2011 3:40 PM

A biotech company that after much turmoil and huge expense launched the first human embryonic stem cell clinical trial in the United States is getting out of the stem cell business.

Geron led the charge to push the U.S. government and society at large to allow use of embryonic stem cells. Scientists believed they could treat myriad diseases because of their ability to become any cell in the human body. But the company has accumulated losses of almost $300 million over the past four years and has halted its stem cell efforts. With few scientists pursuing stem cell research of the embryonic variety, many are wondering if commercial embryonic stem cell research will soon take its final breath.

The cells are controversial because human embryos are destroyed to obtain them. But the company persevered amidst years of public outcry and political punditry and in October 2011 launched the first-ever FDA-approved human trial to treat acute spinal cord injuries. Just four of the 10 approved patients have been treated with Geron’s cells, and now it looks like the other six won’t have their chance. A recently-launched Swiss trial run by Geron will also presumably be halted. The company has laid off 34 percent of its staff and will focus now on cancer treatments. Many patients who held out hope for a paralysis cure will be sorely disappointed.

Advanced Cell Technology is one of the only companies (Stem Cells is another) still using embryonic stem cells. It has human clinical trials active in macular dystrophy and macular degeneration.
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But other companies, like Neuralstem, are poised to pick up the slack using a different and less controversial type of stem cell. Neuralstem uses neural rather than embryonic stem cells, and has already seen remarkable success treating ALS (AKA Lou Gehrig’s disease) patients, which I wrote about here. Neural stem cells are not completely free of controversy: they are taken from a voluntarily aborted fetus. But embryos are not destroyed in order to obtain them. And Neuralstem’s technology allows them to proliferate all the cells they need from a single fetus.

“This was not a surprise to me,” Richard Garr, CEO of Neuralstem, said about the Geron news. “I think the writing was on the wall when Tom Okarma was either pushed out or left on his own. It was pretty clear the they were not interested in being a stem cell company at that point.”

Okarma was Gerons’s CEO for 13 years and was the public face of the company’s fight to use embryonic stem cells.

Meanwhile, Neuralstem has already treated 12 ALS patients, and doctors will treat number 13 on Friday. Garr believes his cells are easier to control and target than embryonic stem cells for treating neural diseases.

Next up for Neuralstem is a human trial testing their cells in chronic spinal cord patients. So we might be saying goodbye to Geron, but not to the hope of spinal cord injured folks getting out of their wheelchairs. [San Francisco Business Times]

Image: Shutterstock/Andrea Danti

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* Running with, not from, cancer

http://www.startribune.com/local/east/132203933.html

Running with, not from, cancer

Article by: TIM HARLOW ,  Sunday, October 23, 2011

Don Wright, 70, plans to run a marathon in all 50 states, a goal he set eight years ago after he was diagnosed with an incurable form of cancer.

Don Wright, 70 didn’t begin running until he was 62, when he was diagnosed with multiple myeloma. Since then he has run 54 marathons in 36 states. Wright ran a practice run near his Lake Elmo home.

Marathon runners know that the 26.2-mile races provide plenty of opportunities for humbling moments. For Don Wright, the first occurs when the horn goes off and he crosses the starting line.

For Wright, 70, each race is another step in his battle to ward off multiple myeloma, a cancer that has no cure and often manifests itself through bone or back pain. It’s also an opportunity to raise money to help other cancer patients pay their medical bills.

“I get very emotional at the start, almost weepy,” said Wright, of Lake Elmo. “As I’m drifting past the scenery, I think about how fortunate I am and how I’m sticking my finger in the eye of the cancer.”

Since he was diagnosed with myeloma eight years ago, Wright has logged more than 1,400 miles in completing 57 marathons in 38 states. He’s won awards for first-place finishes in his age group and clocked times that allowed him to qualify for the prestigious Boston Marathon.

It’s always a thrill to cross the finish line, Wright said, but his proudest accomplishment has been making life better for others.

In each race — including the Marine Corps Marathon in Washington, D.C., on Oct. 30 and his second New York City Marathon on Nov. 6 — Wright runs for Team Continuum, a nonprofit that provides financial assistance to help cover daily living expenses for cancer victims and their families who are saddled with medical bills. Donations can be made at www.startribune.com/a721.

“Running for a great organization like Team Continuum is a way for me to help others lead better lives with cancer,” he said.

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Wright has already beaten those odds, and even though the cancer could sideline him any day, he jokes that his two most immediate concerns are runner’s knee and a sports hernia.

Wright has been able to keep myeloma’s ill effects at bay by skipping traditional chemotherapy and instead taking the experimental drug Pomalidomide daily. He makes monthly trips to the Mayo Clinic in Rochester for checkups. Running is his best form of physical therapy.

“The weight-bearing actually helps preserve bone density,” said Dr. Martha Lacy, Wright’s physician at Mayo who has studied the illness for more than 15 years. “He’s got lots of stamina and his attitude is amazing. He is focused on being well. He’s quite a guy.”

Although he ran cross country in high school, Wright only dabbled in running over the next few decades until he rediscovered his “runner’s urge” when he was in his early 60s, the age when myeloma is most likely to occur. He ran and completed his first marathon — Grandma’s in Duluth — in 4:30:11 in 2003. Just days later, he was diagnosed with the cancer.

“I was shocked. I had no symptoms,” said Wright, a former innovator at Maplewood’s 3M Co. “I thought ‘I have to hurry before it’s too late to run Boston.'”

He achieved that goal in 2004, clocking in at 4:16:07, which led to the larger goal of completing at least one marathon in all 50 states. He’s made it to 41 so far, cheered on by his biggest fans: his wife, Ardis, and daughter, Sarah, who run with him during most of his events.

Wright’s remarkable achievements — physically and medically — are giving doctors hope that one day there will be a cure for myeloma. While they still do not know what causes it, treatments such as Pomalidomide are allowing victims to live longer and maintain a higher quality of life, Lacy said.

“We have been impressed with the drug,” said Lacy, who noted that Wright is among 225 patients who are in a study group which allowed him to be put on the experimental drug. . “It doesn’t work for everybody, but there has been a high response,” Lacy said.

It’s not a cure-all, however, and symptoms could arise at any time. Wright said he has three hot spots in his bones and that makes him a bit nervous.

“There is just no way to know,” he said. “I have no intentions of letting that happen, but I’ve had a good life if that happens.”

Tim Harlow • 651-925-5039 • Twitter: @timstrib