Acupuncture Day and NeuralStem and CDC ALS Registry Articles

I had a TMJ appointment on Friday to take some molds for a day guard to help with my teeth grinding during the day and a night guard to help keep my lower jaw forward to improve breathing and reduce clenching and grinding.  Unfortunately, my gag reflex was so bad that we couldn't take the molds.

Therefore, I had my first acupuncture treatment today to see if they can do anything to help with several issues - chronic sinus allergies, TMJ, and my ALS muscle spasms.  Never had acupuncture before, so was interested to see how it would go.  Because I've had chronic allergies for more than 20 years living in Central PA and worsening TMJ for several years, the doctor indicated it will take more than one treatment to see a marked improvement.  I did think that the ALS-induced muscle spasms were a little better.  She wanted me to come back Friday for a second treatment, but we'll be on our way to NC to see the Knudson clan.  Hopefully we can reduce the muscle spasms and get longer life out of the motor neurons in my limbs.

I have noticed more difficulty speaking clearly.  Kim has been having a harder time understanding me the past 2 weeks, so my speech must be getting worse quickly.  I really need to start investigating the Text to Speech apps for my iPad/iPhone.

Last night I made chicken parm, tonight I am making salsa.  Have a little more shopping to do before we leave Friday and pack Thursday night.

Hilary sent me the following press release on the Neuralstem ALS research project and the ALS Association released the results of the CDC's national ALS registry in the following article.

Final Patient Treated In Neuralstem Phase II ALS Stem Cell Trial

GERMANTOWN, Md., Aug. 4, 2014 /PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) announced that the final patient was treated in its Phase II trial using NSI-566 spinal cord-derived neural stem cells in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). The multicenter Phase II trial treated 15 ambulatory patients in five different dosing cohorts. The first 12 patients received injections in the cervical region of the spinal cord only, where the stem cells could help preserve breathing function, in escalating doses ranging from five injections of 200,000 cells per injection, to 20 injections of 400,000 cells each. The final three patients in the trial received both cervical and lumbar injections, for a total of 40 injections of 400,000 cells each, or a total of 16 million cells transplanted. In contrast, the final three patients in the Phase I trial received the maximum 15 injections of 100,000 cells each, for a total of 1.5 million cells. The trial will continue until six months past the final surgery, at which point the data will be evaluated.

"We are all extremely pleased to have completed the transplantations in this historic Phase II trial," said principal investigator, Dr. Eva Feldman, MD, PhD, Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at the University of Michigan Health System. "By early next year, we will have six-month follow up data on the last patients who received what we believe will be the maximum safe tolerated-dose for this therapy. We look forward to seeing what the data tell us about safety and efficacy of this approach. It is also worth noting that we will have completed this Phase II trial within a year, roughly.  I would like to thank Dr. Parag Patil,  and my collaborators at Emory, Drs. John Glass and Nick Boulis, and at Mass General, Drs. Merit Cudkowicz and Larry Borges, for helping us reach this goal." Dr. Feldman is an unpaid consultant to Neuralstem.

"The completion of Phase II of this important clinical research program is a major milestone, demonstrating that patients can tolerate the transplantation of high doses of cells and multiple spinal cord injections," said site principal investigator,  Jonathan D. Glass, MD, Director of the Emory ALS Center. "From both a clinical and scientific perspective, I think we are now ready to move forward toward a true therapeutic trial to test the efficacy of this surgical approach for slowing the course of ALS."

"We would like to express our thanks to all of the doctors and medical staff who made this possible, as well as the patients and their families. Without their bravery, none of this would have happened," said Karl Johe, PhD, Neuralstem's Chairman of the Board and Chief Scientific Officer.  "With this landmark trial, the first to transplant stem cells in this volume and through so many injections along the length of the human spinal cord, we hope to establish the dose that is both safe and which may be optimal for treatment.  We are excited about the collection and analysis of the final data and look forward to advancing to our next trial."

About Neuralstem
Neuralstem's patented technology enables the production of neural stem cells of the brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glial cells. Neuralstem's NSI-566 spinal cord-derived stem cell therapy Phase II clinical trials for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, concluded final surgeries in July 2014. Neuralstem has been awarded orphan status designation by the FDA for its ALS cell therapy.

In addition to ALS, the company is also targeting major central nervous system conditions with its NSI-566 cell therapy platform, including spinal cord injury and ischemic stroke. The company has received approvals from the FDA and the Institutional Review Board of University of California, San Diego, to commence a Phase I safety trial in chronic spinal cord injury.

Neuralstem also maintains the ability to generate stable human neural stem cell lines suitable for systematic screening of large chemical libraries. Through this proprietary screening technology, Neuralstem has discovered and patented compounds that may stimulate the brain's capacity to generate neurons, possibly reversing pathologies associated with certain central nervous system conditions. The company has completed Phase Ia and Ib trials evaluating NSI-189, its first neurogenic small molecule product candidate, for the treatment of major depressive disorder (MDD), and is expecting to launch a Phase II NSI-189/MDD study in 2015. Additional indications might include traumatic brain injury (TBI), Alzheimer's disease, and post-traumatic stress disorder (PTSD).
For more information, please visit www.neuralstem.com or connect with us on Twitter, Facebook and LinkedIn

Cautionary Statement Regarding Forward Looking Information:
This news release may contain forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of Neuralstem's technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem's periodic reports, including the annual report on Form 10-K for the year ended December 31, 2013 and Form 10Q, for the period ended March 31, 2014.

Logo - http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO
SOURCE Neuralstem, Inc.

For further information: Planet Communications - Media Relations: Deanne Eagle, 917.837.5866; MDC Group - Investor Relations: Susan Roush, 747.222.7012; David Castaneda, 414.351.9758

- See more at: http://investor.neuralstem.com/2014-08-04-Final-Patient-Treated-In-Neuralstem-Phase-II-ALS-Stem-Cell-Trial#Closed



Also, from the ALS Association...

ATSDR Reports First Data Set from the National ALS Registry

 Washington, D.C. (July 24, 2014) — Today, the Agency for Toxic Substances and Disease Registry (ATSDR), a sister agency to the U.S. Centers for Disease Control and Prevention (CDC), reported the first data set from the National ALS Registry, a nationwide research project established by Congress to identify cases of amyotrophic lateral sclerosis (ALS) from throughout the United States and collect vital information leading to the cause, treatment and cure of this fatal neurodegenerative disease.

The report was published in the CDC’s Morbidity and Mortality Weekly Report and includes information collected through national administrative databases (Medicare, Medicaid, Veterans Administration) and from self-reporting by people with ALS. Among the report’s findings:

• Between October 19, 2010 and December 31, 2011, the ALS Registry identified 12,187 people living with ALS in the United States, which means about 4 people out of every 100,000 live with ALS;
• The disease was more common among males, whites, non-Hispanics, and people aged 60 - 69;
• White men and women are about twice as likely to develop the disease as black men and women; and
• The disease is more common in men than women, with a ratio of men to women of 1.56.
• The report represents the first ever population based estimate of the number of people living with ALS in the United States and included information collected during the ALS Registry’s first year of operation, from 2010 - 2011. 

“This initial report is an important milestone for the National ALS Registry and adds to our knowledge of the disease,” said Barbara Newhouse, President and CEO of The ALS Association. “But this is just the beginning; the first step in what is a long-term research project that not only can tell us how many people have ALS, but more importantly, why they have it.  Further enrollment of people living with ALS is critical.”

In addition to identifying the number of cases of ALS throughout the United States, today’s report included preliminary information about risk factor data collected by the registry, including military service, the occupations of those living with ALS as well as smoking and alcohol consumption.  The ATSDR is expected to report their findings once analysis is complete, and this information may help the scientific community learn more about what causes ALS.

The report also noted enhancements that have been made to the ALS Registry, including the creation of a research notification tool to inform people with ALS about research studies in which they may be eligible to participate as well as a feasibility study investigating the creation of a national ALS biorepository.   

“A national biorepository that collects tissue samples from registry participants and links those samples to data already collected by the registry would provide the scientific community a powerful new resource to advance research,” said Lucie Bruijn, Ph.D., MBA, Chief Scientist for The ALS Association.  “Whether it’s the biorepository, the risk factor surveys, or the research notification tool, the registry holds great promise, and we can realize that promise if people with ALS continue to enroll.”   

The ALS Association is working closely with ATSDR and other ALS organizations to raise awareness of the National ALS Registry in communities across the U.S. and to help people with ALS enroll in the registry. To learn more about the National ALS Registry, including how to enroll, please visit the registry page of The ALS Association’s website, http://registry.alsa.org/ or the ATSDR’s ALS Registry website at www.cdc.gov/als. 

ATSDR’s full report is available here: http://www.cdc.gov/mmwr/pdf/ss/ss6307.pdf

About The ALS Association

The ALS Association is the only national non-profit organization fighting Lou Gehrig’s Disease on every front.  By leading the way in global research, providing assistance for people with ALS through a nationwide network of chapters, coordinating multidisciplinary care through certified clinical care centers, and fostering government partnerships, The Association builds hope and enhances quality of life while aggressively searching for new treatments and a cure.  For more information about The ALS Association, visit our website at www.alsa.org.