• "Brain injuries must inspire research push"

Lee Nystrom, chairman of the board, emeritus, of the NFL Alumni Association, spotlights Neuralstem in his op-ed call to the NFL to prevent and fund research to find cures for Chronic Traumatic Encephalopathy (CTE). Nystrom cites the tragic suicides of football greats such as Ray Easterling, Dave Duerson and Junior Seau who have been tied by many to traumatic injuries to the brain.

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• "Give hope to those with ALS"

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.”

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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.

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• "Stem Cell Injections in Lou Gehrig’s Disease can be Given Safely, New Research Shows; U-M ALS expert leads trial at Emory University"

ANN ARBOR, Mich., April 10, 2012 /PRNewswire-USNewswire/ -- The first published results from an early-stage clinical trial show that spinal cord stem cells can be delivered safely into the spines of patients with the condition commonly known as Lou Gehrig's disease, opening the door for further research on this innovative approach.

In a paper published online ahead of print publication in the peer-reviewed journal Stem Cells, a team from the University of Michigan, Emory University and study sponsor NeuralStem, Inc. report the results from 12 patients who took part in a study being conducted at Emory.

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• "New Hope for our toughest diseases"

As the saying goes, there is good news and there is bad news.

Here is the bad news: Right now, there are an estimated 5.4 million Americans suffering from Alzheimer’s disease, one million suffering from Parkinson’s, over five million who have a disease related to a traumatic brain injury, 265,000 with spinal cord injuries, 30,000 who have ALS (Lou Gehrig’s disease), and 129,000 who have brain cancer. Over 25 million Americans also suffer from diabetes – about 8.3% of the population – and the problem is growing.

After that, it’s hard to believe there is good news, but here it is: R & D breakthroughs are happening in science and biotechnology at a remarkable pace to deal with these diseases. Biotech companies are on the front lines to find cures for life-threatening diseases. There are currently 800 new treatments being developed for cancer by biotech companies, 300 for heart disease, 200 for diabetes and 100 for Alzheimer’s, according to the Biotechnology Industry Organization.

Some companies, such as the one I represent, Neuralstem, Inc., are using state-of-the-art stem cell research to attack diseases such as ALS, brain and spinal cord injuries, and down the road, Parkinson’s and Alzheimer’s.

What we need to do now is accelerate this research and speed up the development of new cures for those in desperate need.

There is new legislation, introduced by Senator Kay Hagen (D-N.C.), to expedite development and access to life-saving medicines by the U.S. Food and Drug Administration (FDA). The Transforming and Regulatory Environment to Accelerate Access to Treatments (TREAT) Act will help unleash and accelerate the biotech promise of developing new cures.

This legislation will enable the FDA to speed up the review and approval process and encourage more investment and innovation to attack diseases that are serious or life-threatening. While not all the diseases mentioned above would be covered by this legislation, the legislation provides a much needed jump start on a new approach at the FDA.

America landed a man on the moon in less than a decade and yet it takes 10-15 years to take a new drug from discovery to treating a patient. Given the pace of scientific change, America is held back and patients are suffering because of the long time lags. Investors and private funders are reluctant to invest with the regulatory barriers placed in their way.

According to James Greenwood, president of the Biotechnology Industry Organization, “Sixty-one percent of venture capitalists now cite FDA regulatory challenges as having the highest impact on their investment decisions, and 40% expect to decrease their investment in the development of new therapies.”

The approval process for many of these treatment efforts and drugs is simply unacceptably slow. The TREAT Act will speed it up and have a positive impact on these new breakthrough technologies.  Congress needs to pass it this year.

Our company, Neuralstem, has seen encouraging signs of a treatment effect transplanting our neural stem cells in the spinal chord of ALS patients. Our trial has included 14 patients thus far. Others have implanted stem cells in the eyes and also seen encouraging early signs for treating various types of macular degeneration.

There are potentially important and specific changes championed by this legislation. Most notable among them is a new “standard” that the FDA may adopt to help speed along approval of new therapies for diseases like ALS. The FDA is encouraged to consider surrogate markers of efficacy; and to allow faster approval. For instance, if Neuralstem were to show that we can keep our patients’ breathing function strong enough to stay off of artificial breathing machines for a significant time, we might not have to wait until the patients actually die, to prove that they lived longer, to offer the therapy.

If a company such as Neuralstem demonstrates the benefit of a treatment according to the new FDA standards proposed in the TREAT Act, the therapy can be offered sooner and it can begin benefitting patients sooner. In a disease like ALS, where on average patients die around 3 years from diagnosis, time is clearly of the essence.

The FDA simply must keep pace with the safe and effective development of new, innovative, scientific breakthroughs that can literally provide hope for those with life-threatening diseases. The old, bureaucratic ways simply won’t work in the 21st century.

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• Stem Cells: Plural Paths to Harnessing Pluripotency

Neuralstem’s Dr. Karl Johe shares insights on conditions needed to be met to activate neural stem cells pharmacologically, in order to be a viable strategy for such indications as major depressive disorder, Alzheimer’s disease, schizophrenia and post-traumatic stress disorder (PTSD), with Bioworld Insight’s science editor.

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