GERMANTOWN, Md., March 16, 2015 /PRNewswire/ -- Neuralstem, Inc. (NYSE MKT: CUR) (the "Company" or "Neuralstem") today reported its financial results for the fourth quarter and year ended December 31, 2014.

"Neuralstem has progressed into a clinical development stage company focused on the central nervous system (CNS)," said Richard Garr, Neuralstem President and CEO. "During 2014 we added two established industry leaders as Independent Directors, Catherine Angell Sohn, Pharm.D. and Sandford Drexel Smith. Dr. Sohn is the former Senior Vice President of Business Development and Strategic Alliance, GSK Consumer Healthcare, at GlaxoSmithKline. Mr. Smith is the former Executive Vice President of Genzyme Corporation. The Company moved forward two lead clinical assets: our small molecule neurogenic drug candidate NSI-189 and our spinal derived neural stem cell therapeutic candidate NSI-566. We established and/or grew clinical research programs with leading investigators at Emory University, University of California, San Diego (UCSD), University of Michigan and Massachusetts General Hospital. Our investigators published and presented proof of principle data in both lead assets as highlighted below. In 2015, we plan to begin clinical development of our NSI-189 small molecule drug in a second indication for the treatment of cognitive deficit from schizophrenia, and we plan to initiate a Phase II clinical trial for the ongoing development program for the treatment of major depressive disorder (MDD). The cell therapy programs in amyotrophic lateral sclerosis (ALS), chronic spinal cord injury (cSCI) and stroke will also move forward. We expect this to be another important year continuing our development and progress across both platforms."

2014 Clinical Program and Business Highlights

Neurogenic Small Molecule Platform Clinical Development

Cell Therapy Platform Clinical Development

NSI-566 spinal cord-derived stem cell therapy under development for the treatment of ALS

NSI-566 spinal cord-derived cell therapy under development for the treatment of cSCI

NSI-566 spinal cord derived stem cell therapy under development for the treatment of motor deficits in stroke

NSI-532.IGF second generation gene engineered cell therapy

2014 Business Highlights

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Neuralstem Reports Fiscal 2014 Fourth Quarter Financial And Year-End Business Results

MIAMI (PRWEB) March 17, 2015

GlobalStemCellsGroup.com has announced plans to participate in the 25th annual Argentine Congress of Aesthetic Medicine April 9 and 10 2015. More than 1,000 physicians from around the world will descend on Buenos Aires for the conference to learn and share new findings in aesthetic medicine.

Following the congress, Global Stem Cells Group and Estanislao Janowski, M.D., a plastic surgeon specializing in stem cell application in aesthetic and cosmetic medicine will conduct an intensive, hands-on course on stem cell harvesting, isolation and re-integration, to be held April 11. Janowski, a GSCG faculty member and long-time collaborator is the owner and president of Bioplastica, an aesthetic surgical center featuring the latest stem cell applications in cosmetic and anti-aging medicine.

This will be the third year Global Stem Cells Group participates in the conference, hosted by the Argentina Society of Aesthetic Medicine (SOARME). A soon-to-be-named GSCG faculty member will also deliver a keynote speech to congress attendees.

The international event, which will be held at the Catholic University of Argentina in Buenos Aires, will feature acclaimed stem cell aesthetic practitioners from Argentina and the U.S. SOAME is a member of the Argentine Medical Association (A.M.A.) and of the International Union of Aesthetic Medicine (U.I.M.E.). SOAME has the scientific support of the John F. Kennedy University in Buenos Aires and a host of national and international scientific organizations.

For more information visit the Global Stem Cells Group website, email bnovas(at)regenestem(dot)com, or call 305-224-1858.

About the Global Stem Cells Group:

Global Stem Cells Group, Inc. is the parent company of six wholly owned operating companies dedicated entirely to stem cell research, training, products and solutions. Founded in 2012, the company combines dedicated researchers, physician and patient educators and solution providers with the shared goal of meeting the growing worldwide need for leading edge stem cell treatments and solutions.

With a singular focus on this exciting new area of medical research, Global Stem Cells Group and its subsidiaries are uniquely positioned to become global leaders in cellular medicine.

Global Stem Cells Groups corporate mission is to make the promise of stem cell medicine a reality for patients around the world. With each of GSCGs six operating companies focused on a separate research-based mission, the result is a global network of state-of-the-art stem cell treatments.

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Global Stem Cells Group to Participate in the 25th Argentine Congress of Aesthetic Medicine in Buenos Aires April 9-10 ...

Jeremy #39;s Stem cell therapy journey
This is a video about stem cells and stem cell therapy. Created by #39;Vivienne Armstrong #39;.-- Created using PowToon -- Free sign up at http://www.powtoon.com/join -- Create animated videos and...

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Jeremy's Stem cell therapy journey - Video

Dr. Nathan Newman - Stem Cell Therapy and Regenerative Medicine
Dr. Nathan Newman is a Board Certified Dermatologist, a Cosmetic Surgeon, and a pioneer in stem cell therapy and Regenerative Medicine. He is world-renowned for his ground-breaking Stem Cell...

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Dr. Nathan Newman - Stem Cell Therapy and Regenerative Medicine - Video

Orange, California (PRWEB) March 17, 2015

The top stem cell therapy clinics in California, Telehealth, are now offering treatment for nonhealing wounds at three locations. The stem cell therapy for wound healing is being offered by Board Certified doctors at three separate locations in Orange, La Jolla and Upland. Call (888) 828-4575 for more information and scheduling.

Patients with diabetes, neuropathy and autoimmune disorders often find it difficult to heal even minor wounds. This may lead to diabetic ulcers and infections in the soft tissue and/or bone. At times, even the most rigorous conventional wound care fails to heal wounds sufficiently.

At Telehealth, stem cell therapy for nonhealing wounds has been showing exceptional results. Wounds that had basically been unresponsive to traditional methods have displayed quick results with healing when the procedures are performed. The regenerative medicine treatments involve either bone marrow derived stem cells or amniotic derived stem cells. Additional, PRP therapy is included in the treatment at times when necessary.

Along with helping to heal difficult wounds, stem cell therapy is also available for degenerative arthritis, chronic tendonitis, rotator cuff tears, ligament injuries, migraines and much more. Treatments are offered in Orange, Upland and a new La Jolla location by Board Certified doctors with extensive experience.

Most treatments are partially covered by insurance, which helps considerably to keep cost down. Call (888) 828-4575 for more information and scheduling.

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Stem Cell Therapy Now Being Offered for NonHealing Wounds at Telehealth's Three Regenerative Medicine Clinics

Beverly Hills, California (PRWEB) March 17, 2015

Beverly Hills Orthopedic Institute is now offering stem cell procedures for the nonoperative treatment of shoulder labral tears. The procedures are outpatient, low risk, and very effective at helping patients avoid the need for surgery. Call Beverly Hills Orthopedic Institute at (310) 247-0466 for more information and scheduling.

Injuries to the shoulder may involve rotator cuff tendonitis, tears or labral injury. Stem cell therapy is typically effective for all of these conditions, and Dr. Raj has been having significant success with labral tears. Conventional treatment for labral tears is often unsuccessful, as they typically do not have sufficient blood supply.

Treatment with regenerative medicine offers the potential to avoid surgery and heal the tissues. The stem cell therapy includes either bone marrow or amniotic derived treatment. Both of these are outpatient and very low risk. Small studies have shown the effectiveness of stem cell treatment for joint arthritis, tendonitis, tendon tears, cartilage defects and labral tears.

The treating physician, Dr. Raj, is a Double Board Certified orthopedic surgeon Beverly Hills trusts, and excels in treating all kinds of sports injuries and arthritic conditions. He also serves as a Medical Correspondent for ABC News, along with receiving numerous LA TOP DOC and Top Doctors Southern California Awards.

To receive the best stem cell therapy in Los Angeles and Beverly Hills, call the Institute today at (310) 247-0466.

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Beverly Hills Orthopedic Institute Now Offering Stem Cell Therapy for Nonoperative Shoulder Labral Tears

A TEENAGER'S quest to find a bone marrow match and beat his leukaemia has inspired school friends to go on to save the lives of two perfect strangers.

Jack Coen and Joe Rowbottom, both 18, were at Bradford Grammar School when fellow pupil Alex Anstess, now 16, was first diagnosed with Acute Myeloid Leukaemia in 2012.

After hearing a talk in school about registering on the Anthony Nolan Bone Marrow register, they - and others - signed up and both of them have gone on to successfully donate stem cells.

Jack, from Ilkley, who donated in October last year after being found to be a perfect match for a patient needing a bone marrow transplant, said: I just thought if you have the opportunity to save someones life then why not? If I was in that position, Id want someone to do it for me.

"On the day, I thought about the other person receiving my stem cells and hoped I could give them more Christmases with their family. If I never make another good decision for the rest of my life, I have at least made one good and worthwhile decision by donating."

And Joe, from Yeadon, who donated his stem cells last month, said: It was so easy to spit in a tube and sign up. It was weird to think a stranger was dependent on me and yet its such a small thing to do. It was actually surprising something so simple could save someones life. Knowing Alex spurred me on to donate because I knew what the person was going through. Its great to see Alex back at school and proves the donor register does work.

Although Alex, of Cullingworth, had gone into remission after his 2012 diagnosis, the cancer returned in July last year and doctors broke the news that his life depended on a bone marrow transplant. It was The Anthony Nolan Trust that found him a perfect match and he had the procedure in September last year, helping him on the road to recovery.

His mum, Sue, said: I cannot describe the feeling of seeing that little bag of stem cells come in for Alex. We waited a long time for that moment and Ill never forget the relief we felt. Were so thankful to the donor who literally saved his life. Its absolutely brilliant that Jack and Joe have gone on to donate and help another family like ours."

Bradford Grammar headteacher Kevin Riley said: The school motto is Hoc Age which we usually translate as Just do it. What a wonderful example Jack and Joe are of that determination to help others. Im proud of them and the other students who have responded to the appeal.

If you are aged 16-30 and in good health you too can sign up to the Anthony Nolan register at anthonynolan.org. To find out more about the Register & Be a Lifesaver programme, email registerandbe@AnthonyNolan.org or call 0207 284 8213.

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Teenager's quest to beat leukaemia inspires school friends to donate stem cells to help people in need

Stem cells are special cells that can turn into any kind of cells in the body. They serve as a repair system for the body. There are two main types of human stem cells: embryonic stem cells and adult stem cells.

Embryonic stem cells are cells that come from an unborn baby (embryo). Those are NOT the cells that are used for this product.LUMINESCEformulation uses technology derived from the study of Adult Stem Cells.

Stem cells communicate with tissue cells to induce repair. They produce many different growth factors and "communication" chemicals to do this.Dr Nathan Newmanhas been able to take stem cells in the lab, and separate them from the solution that holds the growth factors. This media is the foundation of theLUMINESCEproduct.

What is the relationship between growth factors and the stem cell technology?

The patent-pending technology ofLUMINESCEprovides for the delivery of key growth factors found in natural skin. As we age, the production of these growth factors within skin is reduced, and leads to wrinkling and thinning of the skin. By re-introducing these factors through the daily application ofLUMINESCE, damaged skin cells may be repaired, and skin tissue re-generated.

Stem cells are cells that have the ability to grow into any kind of cell in the body, and they rely on special signals to tell them what cells they will ultimately become. If you know the stem cell language, then you could communicate to the cells.

In this way, you could have stem cells that become new young skin cells, rebuild collagen, and deliver a new younger looking skin.

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Stem Cells, Skin Care and Dr Newman | Skin Care

Steve Perrin, Ph.D., CEO and CSO, discusses why iPS technology is ready for drug discovery for today's ALS patients. Click here to learn why Steve believes TDI is uniquely suited to implement this technology in ALS research.

Fernando Vieira, M.D., director of research operations, discusses how iPS technology can be used to model sporadic ALS, help to identify sub-types of ALS patients and accelerate drug development as part of a comprehensive translational research program at ALS TDI.

Jessie St. Martin, associate scientist, talks about induced pluripotent stem cells (iPS cells) and their importance in ALS research. Jessie, a recent addition to the translational research team, will play an integral part in developing this program at ALS TDI. Click here to learn more about iPS cells.

Jenny Dwyer, board member, explains why your support of the iPS program at ALS TDI may have the ability to rapidly accelerate treatments for today's patients. Jenny was a longtime ALS caregiver of her husband, Pat. Together, they were advocates for ALS research. Click here to listen to her message.

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Invest in iPS @ TDI | ALS Therapy Development Institute

Nova Cells Institute treatment Report, stem cell therapy, 562-916-3410
Nova Cells Institute stem cell treatment report shows success with spina bifida, lewy body dementia, cancer patients and more - visit http://www.novacellsinstitute.com to learn more.

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Nova Cells Institute treatment Report, stem cell therapy, 562-916-3410 - Video

Orthopedic Stem Cell Therapy - Queens, New York
Benjamin Bieber MD of #CrossBayPMR in Howard Beach, New York has had great success with #stemcell therapy using your own fat cells. Avoid invasive #jointreplacement surgery and get back to...

By: Cross Bay Physical Medicine and Rehabilitation, P.C.

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Orthopedic Stem Cell Therapy - Queens, New York - Video

The New Botox: Stem Cell Therapy Cream Reviews
http://buildingabrandonline.com/buildabrandwithjamalspikes/what-is-jeunesse/ The New Botox: Stem Cell Therapy Cream Reviews Stem cell therapy is the use of stem cells to treat or prevent a...

By: Jamal Spikes

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The New Botox: Stem Cell Therapy Cream Reviews - Video

Fauza D: Amniotic fluid and placental stem cells.

Best Pract Res Clin Obstet Gynaecol 2004, 18:877-891. PubMedAbstract | PublisherFullText

Parolini O, Alviano F, Bagnara GP, Bilic G, Bhring HJ, Evangelista M, Hennerbichler S, Liu B, Magatti M, Mao N, Miki T, Marongiu F, Nakajima H, Nikaido T, Portmann-Lanz CB, Sankar V, Soncini M, Stadler G, Surbek D, Takahashi TA, Redl H, Sakuragawa N, Wolbank S, Zeisberger S, Zisch A, Strom SC: Concise review: isolation and characterization of cells from human term placenta: outcome of the first international workshop on placenta derived stem cells.

Stem Cells 2008, 26:300-311. PubMedAbstract | PublisherFullText

Pozzobon M, Ghionzoli M, De Coppi P: ES, iPS, MSC, and AFS cells. Stem cells exploitation for Pediatric Surgery: current research and perspective.

Pediatr Surg Int 2010, 26:3-10. PubMedAbstract | PublisherFullText

Miki T, Marongiu F, Dorko K, Ellis EC, Strom SC: Isolation of amniotic epithelial stem cells.

Curr Protoc Stem Cell Biol 2010, Chapter 1:Unit 1E 3. PubMedAbstract | PublisherFullText

Miki T, Strom SC: Amnion-derived pluripotent/multipotent stem cells.

Stem Cell Rev 2006, 2:133-142. PubMedAbstract | PublisherFullText

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Stem Cell Research & Therapy | Full text | Amnion-derived ...

Importance Most patients with relapsing-remitting (RR) multiple sclerosis (MS) who receive approved disease-modifying therapies experience breakthrough disease and accumulate neurologic disability. High-dose immunosuppressive therapy (HDIT) with autologous hematopoietic cell transplant (HCT) may, in contrast, induce sustained remissions in early MS.

Objective To evaluate the safety, efficacy, and durability of MS disease stabilization through 3 years after HDIT/HCT.

Design, Setting, and Participants Hematopoietic Cell Transplantation for Relapsing-Remitting Multiple Sclerosis (HALT-MS) is an ongoing, multicenter, single-arm, phase 2 clinical trial of HDIT/HCT for patients with RRMS who experienced relapses with loss of neurologic function while receiving disease-modifying therapies during the 18 months before enrolling. Participants are evaluated through 5 years after HCT. This report is a prespecified, 3-year interim analysis of the trial. Thirty-six patients with RRMS from referral centers were screened; 25 were enrolled.

Interventions Autologous peripheral blood stem cell grafts were CD34+ selected; the participants then received high-dose treatment with carmustine, etoposide, cytarabine, and melphalan as well as rabbit antithymocyte globulin before autologous HCT.

Main Outcomes and Measures The primary end point of HALT-MS is event-free survival defined as survival without death or disease activity from any one of the following outcomes: (1) confirmed loss of neurologic function, (2) clinical relapse, or (3) new lesions observed on magnetic resonance imaging. Toxic effects are reported using National Cancer Institute Common Terminology Criteria for Adverse Events.

Results Grafts were collected from 25 patients, and 24 of these individuals received HDIT/HCT. The median follow-up period was 186 weeks (interquartile range, 176-250) weeks). Overall event-free survival was 78.4% (90% CI, 60.1%-89.0%) at 3 years. Progression-free survival and clinical relapse-free survival were 90.9% (90% CI, 73.7%-97.1%) and 86.3% (90% CI, 68.1%-94.5%), respectively, at 3 years. Adverse events were consistent with expected toxic effects associated with HDIT/HCT, and no acute treatment-related neurologic adverse events were observed. Improvements were noted in neurologic disability, quality-of-life, and functional scores.

Conclusions and Relevance At 3 years, HDIT/HCT without maintenance therapy was effective for inducing sustained remission of active RRMS and was associated with improvements in neurologic function. Treatment was associated with few serious early complications or unexpected adverse events.

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High-Dose Immunosuppressive Therapy and Autologous ...

Miracle stem cell therapy reverses multiple sclerosis
Latest research on stem cell therapy in curing MS.

By: Dulci Hill

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Miracle stem cell therapy reverses multiple sclerosis - Video

Former Homeland Star David Harewood Has Written An Online Article Urging Black U.k. Residents To Sign Up To The Stem Cell Donor Register.

The actor has teamed up with stem cell charity Anthony Nolan and the African-Caribbean Leukaemia Trust (ACLT) to launch an appeal encouraging young, black Brits to donate bone marrow so leukaemia sufferers in ethnic minorities have a better chance of receiving pioneering stem cell treatment.

Harewood has written an online article for Independent.co.uk in which he details the stem cell donation process for the African-Caribbean community, and encourages them to take part.

He writes, "The black population is badly underrepresented on the bone marrow register compiled by the blood cancer charity Anthony Nolan. In fact, there are 30 times more white people than African-Caribbean people willing to donate their stem cells in this country.

"The result of this? If you're black and have leukaemia then you have less than a 20 per cent chance of finding the best possible match when your last hope of survival is a lifesaving transplant from a stranger. We are literally dying, not because a matching donor isn't out there somewhere - but because that person never joined the register.

"This isn't right, and it urgently needs to change. It's horrible to think that if my daughters needed a transplant they would be at a disadvantage because there aren't enough black and mixed race donors on the register."

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David Harewood Launches Appeal For Black Stem Cell Donors

Hip and shoulder arthritis six months after bone marrow stem cell therapy by Harry Adelson ND
Mareen describes her outcome six months after her bone marrow stem cell treatment by Harry Adelson ND for arthritis of her hip and shoulder http://www.docereclinics.com.

By: Harry Adelson, N.D.

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Hip and shoulder arthritis six months after bone marrow stem cell therapy by Harry Adelson ND - Video

Posted: Thursday, March 12, 2015 7:08 PM

UCLA stem-cell researchers have shown that a novel stem-cell gene therapy method could one day provide a one-time, lasting treatment for the most common inherited blood disorder in the U.S. sickle cell disease. Publishedin the journal Blood, the study outlines a method that corrects the mutated gene that causes sickle cell disease and shows, for the first time, the gene correction method leads to the production of normal red blood cells. The study was directed by renowned stem cell researcher and UCLA Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research member, Dr. Donald Kohn.

People with sickle cell disease are born with a mutation in their beta-globin gene, which is responsible for delivering oxygen to the body through blood circulation. The mutation causes blood stem cellswhich are made in the bone marrowto produce distorted and rigid red blood cells that resemble a crescent or sickle shape. Consequently, the abnormally shaped red blood cells do not move smoothly through blood vessels, resulting in insufficient oxygen supply to vital organs. Anyone can be born with sickle cell disease, but it occurs more frequently in African Americans and Hispanic Americans.

The stem-cell gene therapy method described in the study seeks to directly correct the mutation in the beta-globin gene so bone marrow stem cells then produce normal, circular-shaped blood cells that do not sickle. The fascinating gene correction technique used specially engineered enzymes, called zinc-finger nucleases, tocut out the mutated genetic code and replace it with a corrected version that repairs the beta-globin mutation.

For the study, bone marrow stem cells donated by people with the sickle cell gene mutation were treated in the laboratory with the zinc-finger nucleases enzyme cutting method.Kohn and his team then demonstrated in mouse models that thecorrected bone-marrow stem cells have the capability to replicate successfully. The research showed that the method holds the potential to permanently treat the disease if a higher level of correction is achieved.

This is a very exciting result,said Dr. Kohn, professor of pediatrics atUCLAs David Geffen School of Medicine, professor of microbiology, immunology and molecular genetics in Life Sciences at UCLA, member of the UCLA Childrens Discovery and Innovation Institute at Mattel Childrens Hospital and senior author on the study. It suggests the future direction for treating genetic diseases will be by correcting the specific mutation in a patients genetic code. Since sickle cell disease was the first human genetic disease where we understood the fundamental gene defect,and since everyone with sickle cell has the exact same mutation in the beta-globin gene, it is a great target for this gene correction method.

To make the cut in the genetic code, Dr. Kohn and his team used zinc-finger nucleases engineered by Sangamo BioSciences, Inc., in Richmond. The enzymes can be designed to recognize a specific and targeted point in the genetic code. For the study, scientists at Sangamo BioSciences engineered the enzymes to create a cut at the site of the mutated genetic code that causes sickle cell disease. This break triggered a natural process of repair in the cell and at the same time, a molecule containing the correct genetic code was inserted to replace the mutated code.

The next steps in this research will involve improving the efficiency of the mutation correction process and performing pre-clinical studies to demonstrate that the method is effective and safe enough to move to clinical trials.

Symptoms of sickle cell disease usually begin in early childhood and include a low number of red blood cells (anemia), repeated infections and periodic episodes of pain. People with sickle cell disease typically have a shortened lifespan of just 36-40 years of age. The disease impacts more than 250,000 new patients worldwide each year. The only cure currently available for sickle cell disease is a transplant of bone marrow stem cells from a matched sibling, but matches are rare or can result in rejection of the transplanted cells.

This is a promising first step in showing that gene correction has the potential to help patients with sickle cell disease, said Megan Hoban, a senior graduate student in microbiology, immunology and molecular genetics and first author on the study. The study data provide the foundational evidence that the method is viable.

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UCLA Research Shows Promising Method For Correcting Genetic Code To Treat Sickle Cell Disease

BOSTON (TheStreet) --A question about Neuralstem (CUR - Get Report) and its stem-cell therapy for ALS kicks off this week's Biotech Stock Mailbag.

Steve writes, "If 47% of the people responded well and their progression of the disease slowed considerably, then I see this as a huge success for a disease with no cure. I don't have ALS or know anyone that does, but if I had it, I would immediately want the treatment knowing that there is a 47% chance that I will respond positively to it and it would DRASTICALLY slow the progression of the disease. Wouldn't you agree, or am I missing the point somewhere?"

Eight of the 15 (53%) ALS patients enrolled in the study saw their ALSFRS scores fall from an average of 40 to 14 over nine months. This is a rapid decline in muscle function and suggests NSI-566 accelerates the progression of ALS.

If you believe 47% of patients in the Neuralstem study benefit from NSI-566, you can't ignore the 53% of patients who fare far worse and may actually be harmed by the stem cell therapy.

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Biotech Stock Mailbag: Neuralstem, Genfit, Intercept, Amarin

GERMANTOWN, MD, March 12, 2015 -- Neuralstem, Inc. (NYSE MKT: CUR) announced top line data from the Phase II trial of NSI-566 spinal cord-derived neural stem cells under development for the treatment of amyotrophic lateral sclerosis (ALS). The study met primary safety endpoints. The maximum tolerated dose of 16 million transplanted cells and the surgery was well tolerated.

Secondary efficacy endpoints at nine months post-surgery indicate a 47% response rate to the stem cell treatment, as measured by either near-zero slope of decline or positive slope of ALSFRS score in seven out of 15 patients and by either a near-zero decline, or positive strengthening, of grip strength in seven out of 15 patients. Grip strength is an indicator of direct muscle strength of the lower arm. ALSFRS is a standard clinical test used to evaluate the functional status of ALS patients. The average ALSFRS score for responders at 9 months after treatment was 37. Non-responders scored an average of 14. These scores represent 93%, versus 35%, of the baseline score retained, respectively, by the responders versus non-responders at 9 months, which is a statistically significant difference. As measured by an average slope of decline of ALSFRS, responders' disease progression was -0.007 point per day, while non-responders' disease progression was -0.1 per day, which was again statistically significant. Lung function as measured by Seated Vital Capacity shows that responder patients remained within 94% of their starting scores, versus 71% for non-responder patients. The trial met its primary safety endpoints. Both the surgery and cells were well-tolerated, with one patient experiencing a surgical serious adverse event.

"In this study, cervical intervention was both safe and well-tolerated with up to 8 million cells in 20 bilateral injections," said Karl Johe, PhD, Neuralstem Chief Scientific Officer. "The study also demonstrated biological activity of the cells and stabilization of disease progression in a subset of patients. As in the first trial, there were both responders and non-responders within the same cohort, from patients whose general pre-surgical presentation is fairly similar. However, we believe that through the individual muscle group measurements, we may now be able to differentiate the responders from the non-responders.

"Our therapy involves transplanting NSI-566 cells directly into specific segments of the cord where the cells integrate into the host motor neurons. The cells surround, protect and nurture the patient's remaining motor neurons in those various cord segments. The approximate strength of those remaining motor neuron pools can be measured indirectly through muscle testing of the appropriate areas, such as in the grip strength tests. We believe these types of endpoints, measuring muscle strength, will allow us to effectively predict patients that will respond to treatment, adding a sensitive measure of the therapeutic effects after treatment. Testing this hypothesis will be one of the primary goals of our next trial." The full data is being compiled into a manuscript for publication.

"We believe the top-line data are encouraging," said 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, and an unpaid consultant to Neuralstem. "We were able to dose up to 16 million cells in 40 injections, which we believe to be the maximum tolerated dose. As in the first trial, the top-line data show disease stabilization in a subgroup of patients. Perhaps equally as important, we believe the top-line data may support a method of differentiating responders from non-responders, which we believe will support our efforts as we move into the next, larger controlled trial expected to begin this summer."

"The top-line data look very positive and encouraging. If this proportion of patients doing well after treatment can be corroborated in future therapeutic trials, it will be better than any response seen in any previous ALS trials," said site principal investigator, Jonathan D. Glass, MD, Director of the Emory ALS Center. "Elucidating which factors define a patient who may have a therapeutic response to the stem cell treatment will be the next key challenge. We are hopeful that a set of predictive algorithms can be established to help pre-select the responders in our future trials."

"We were very excited to participate as a site in this clinical trial," said Merit Cudkowicz, MD, Chief of Neurology, Massachusetts General Hospital and Co-Chair of the Northeast ALS Consortium (NEALS). "We are hopeful with respect to the top-line results and we need to move swiftly and safely forward to confirm the responder effect and identify people who might benefit from this treatment approach."

The open-label, dose-escalating trial treated 15 ambulatory patients, divided into 5 dosing cohorts, at three centers, Emory University Hospital in Atlanta, Georgia, the ALS Clinic at the University of Michigan Health System, in Ann Arbor, Michigan, and Massachusetts General Hospital in Boston, Massachusetts, and under the direction of principal investigator (PI), 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. Dosing increased from 1 million to 8 million cells in the cervical region of the spinal cord. The final trial cohort also received an additional 8 million cells in the lumbar region of the spinal cord.

The company anticipates commencing a later-stage, multicenter trial of NSI-566 for treatment of ALS in 2015. Neuralstem has received orphan designation by the FDA for NSI-566 in ALS.

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Neuralstem announces topline results of Phase II ALS trial