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Neuralstem CEO to Present at the World Stem Cells and Regenerative Medicine Congress in London

Posted: May 22, 2012 at 10:10 am

ROCKVILLE, Md., May 21, 2012 /PRNewswire/ --Neuralstem, Inc. (NYSE MKT: CUR) announced that Richard Garr, CEO and President, will present at the World Stem Cells & Regenerative Medicine Congress in London (http://www.terrapinn.com/2012/stemcells/index.stm) on Tuesday, May 22nd at 12:30 PM. Mr. Garr's presentation, "Stem Cell Applications for Neurodegenerative Disorders," will review Neuralstem's cellular therapy trial in ALS, its neurogenic small molecule trial in major depressive disorder (MDD), and provide an overview on plans to expand the cellular therapy program.

(Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO )

About Neuralstem

Neuralstem's patented technology enables the ability to produce neural stem cells of the human 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 glia. Neuralstem is in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, and has been awarded orphan status designation by the FDA.

In addition to ALS, the company is also targeting major central nervous system conditions with its cell therapy platform, including spinal cord injury, ischemic spastic paraplegia and chronic stroke. The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I safety trial in chronic spinal cord injury.

Neuralstem also has the ability to generate stable human neural stem cell lines suitable for the 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 new neurons, possibly reversing the pathologies of some central nervous system conditions. The company has received approval from the FDA to conduct a Phase Ib safety trial evaluating NSI-189, its first neurogenic small molecule compound, for the treatment of major depressive disorder (MDD). Additional indications could include CTE (chronic traumatic encephalopathy), Alzheimer's disease, anxiety, and memory disorders.

For more information, please visit http://www.neuralstem.com or connect with us on Twitter and Facebook.

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, 2011 and the Form 10-Q for the period ended March 30, 2012.

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Neuralstem CEO to Present at the World Stem Cells and Regenerative Medicine Congress in London

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World's First Stem Cell Drug From Osiris: Approved

Posted: May 22, 2012 at 10:10 am

Editor's Choice Main Category: Pediatrics / Children's Health Also Included In: Stem Cell Research Article Date: 21 May 2012 - 0:00 PDT

Current ratings for: 'World's First Stem Cell Drug From Osiris: Approved'

4.75 (4 votes)

The decision is a historic one, as it's both the first stem cell drug going into formal use, as well as the first treatment for GvHD. The disease is a devastating breakdown occurring after a bone marrow transplant and kills around 80% of children affected, often within a matter of weeks.

Andrew Daly, M.D., Clinical Associate Professor, Department of Medicine and Oncology at the University of Calgary, Canada and Principal Investigator in the phase 3 clinical program for Prochymal confirmed :

The approval process for Prochymal was implemented under Health Canada's Notice of Compliance with conditions (NOC/c) pathway. The basis of the procedure allows a new drug to come onto the market where there are unmet medical needs. The approval is granted with the provision that the drug has demonstrated risk / reward benefits in previous clinical trials and that the manufacturer agrees to undertake additional confirmatory clinical testing.

C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris confirmed his' companies happiness at being able to help conquer the disease :

Where children with GvHD are not responding to treatment with steroids, which is presumably most of them, the use of Prochymal will now be authorized. Health Canada based it's approval on previous clinical studies of the drug, in which 64% of patients showed results; the survival rate compared to historical data was drastically improved, even in patients with severe cases. Additional clinical evaluation of Prochymal now will be undertaken, including enrolling patients in a registry to discover any long term effects.

Joanne Kurtzberg, MD, Head of the Pediatric Bone Marrow Transplant Program at Duke University and Lead Investigator for Prochymal

Osiris has 48 patents protecting Prochymal, and Health Canada's have agreed to provide Prochymal with regulatory exclusivity within their territory. Canada affords eight years of exclusivity to Innovative Drugs, such as Prochymal, with an additional six-month extension because it addresses a pediatric disease. Parents, doctors and shareholders can all rest easy.

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World's First Stem Cell Drug From Osiris: Approved

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Family hangs hope on stem cells

Posted: May 22, 2012 at 10:10 am

Indian clinic's stem cell therapy real?

STORY HIGHLIGHTS

For more of CNN correspondent Drew Griffin's investigation of India's experimental embryonic stem cell therapy, watch "CNN Presents: Selling a Miracle," at 8 and 11 p.m. ET Sunday on CNN.

New Delhi (CNN) -- Cash Burnaman, a 6-year-old South Carolina boy, has traveled with his parents to India seeking treatment for a rare genetic condition that has left him developmentally disabled. You might think this was a hopeful mission until you learn that an overwhelming number of medical experts insist the treatment will have zero effect.

Cash is mute. He walks with the aid of braces. To battle his incurable condition, which is so rare it doesn't have a name, Cash has had to take an artificial growth hormone for most of his life.

His divorced parents, Josh Burnaman and Stephanie Krolick, are so driven by their hope and desperation to help Cash they've journeyed to the other side of the globe and paid tens of thousands of dollars to have Cash undergo experimental injections of human embryonic stem cells.

The family is among a growing number of Americans seeking the treatment in India -- some at a clinic in the heart of New Delhi called NuTech Mediworld run by Dr. Geeta Shroff, a retired obstetrician and self-taught embryonic stem cell practitioner.

Shroff first treated Cash -- who presents symptoms similar to Down Syndrome -- in 2010. "I am helping improve their quality of life," Shroff told CNN.

After five weeks of treatment, Cash and his parents returned home to the U.S.

That's when Cash began walking with the aid of braces for the first time.

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Family hangs hope on stem cells

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Nature Neuroscience Study Shows Unique Scientific Support for Potential New Myelin Repair Treatment for Multiple …

Posted: May 21, 2012 at 3:13 am

SARATOGA, Calif.--(BUSINESS WIRE)--

The Myelin Repair Foundation (MRF) today announced the results of a new peer-reviewed research study published in Nature Neuroscience that demonstrates functional improvement in immune response modulation and myelin repair with factors derived from mesenchymal stem cell (MSC) treatment in animal models of multiple sclerosis (MS). Funded by the Myelin Repair Foundation, this research conducted by Case Western Reserve University scientists showed positive results with human mesenchymal stem cells in animal models of MS by not only successfully blocking the autoimmune MS response, but also repairing myelin, demonstrating an innovative potential myelin repair treatment for MS.

Multiple sclerosis is a disease of the immune system that attacks the myelin, causing exposed nerves or lesions which block brain signals, causing loss of motor skills, coordination and cognitive ability. Compared to the controls, this research study showed fewer and smaller lesions found on the nerves in the MSC treatment group. MSCs were found to block the formation of scar tissue by suppressing the autoimmune response, which would otherwise cause permanent damage to the nerves. Furthermore, the research showed that MSC treatment also repaired myelin, enhancing myelin regeneration of the damaged axon and the rewrapping of the myelin around the axon in animal models of MS. One treatment of MSCs provided long-term protection of the recurring disease.

Led by Myelin Repair Foundation Principal Investigator and Vice President for Research & Technology Management at Case Western Reserve Universitys Dr. Robert Miller, this study documents a new promising pathway for treating multiple sclerosis that blocks the autoimmune response and reverses the myelin damage in animal models of MS. The human MSCs used in this study were culled from adult stem cells derived from the bone marrow.

We are thrilled with the publication of this important research study that examines a new pathway to treat multiple sclerosis, one that reverses the damage of the disease, said Dr. Robert Miller. Since we were just beginning to understand how MSCs provide myelin repair for lesions, with the Myelin Repair Foundations support, we continue to deepen our knowledge of exploring the next generation of MS treatments that stimulate healing, rather than symptom suppression of the disease.

We pride ourselves on supporting best-in-class scientists devoted to find new ways to treat multiple sclerosis, advancing highly innovative research projects that otherwise would not have moved forward, said Scott Johnson, president of the Myelin Repair Foundation. The success of Case Western Reserve Universitys study and recognition in this prestigious journal furthers our goal to identify new pathways to treat multiple sclerosis by supporting a multi-disciplinary team of the best researchers in the field.

About the Myelin Repair Foundation

The Myelin Repair Foundation (MRF) (http://www.myelinrepair.org) is a Silicon Valley-based, non-profit research organization focused on accelerating the discovery and development of myelin repair therapeutics for multiple sclerosis. Its Accelerated Research Collaboration (ARC) model is designed to optimize the entire process of medical research, drug development and the delivery of patient treatments.

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World's First Stem Cell Drug From Osiris : Approved!

Posted: May 21, 2012 at 3:13 am

Editor's Choice Main Category: Pediatrics / Children's Health Also Included In: Stem Cell Research Article Date: 20 May 2012 - 11:00 PDT

Current ratings for: 'World's First Stem Cell Drug From Osiris : Approved!'

5 (1 votes)

The decision is a historic one, as it's both the first stem cell drug going into formal use, as well as the first treatment for GvHD. The disease is a devastating breakdown occurring after a bone marrow transplant and kills around 80% of children affected, often within a matter of weeks.

Andrew Daly, M.D., Clinical Associate Professor, Department of Medicine and Oncology at the University of Calgary, Canada and Principal Investigator in the phase 3 clinical program for Prochymal confirmed :

The approval process for Prochymal was implemented under Health Canada's Notice of Compliance with conditions (NOC/c) pathway. The basis of the procedure allows a new drug to come onto the market where there are unmet medical needs. The approval is granted with the provision that the drug has demonstrated risk / reward benefits in previous clinical trials and that the manufacturer agrees to undertake additional confirmatory clinical testing.

C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris confirmed his' companies happiness at being able to help conquer the disease :

Where children with GvHD are not responding to treatment with steroids, which is presumably most of them, the use of Prochymal will now be authorized. Health Canada based it's approval on previous clinical studies of the drug, in which 64% of patients showed results; the survival rate compared to historical data was drastically improved, even in patients with severe cases. Additional clinical evaluation of Prochymal now will be undertaken, including enrolling patients in a registry to discover any long term effects.

Joanne Kurtzberg, MD, Head of the Pediatric Bone Marrow Transplant Program at Duke University and Lead Investigator for Prochymal

Osiris has 48 patents protecting Prochymal, and Health Canada's have agreed to provide Prochymal with regulatory exclusivity within their territory. Canada affords eight years of exclusivity to Innovative Drugs, such as Prochymal, with an additional six-month extension because it addresses a pediatric disease. Parents, doctors and shareholders can all rest easy.

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World's First Stem Cell Drug From Osiris : Approved!

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Heart Disease, Diabetes, Depression a Deadly Mix

Posted: May 20, 2012 at 3:57 pm

(HealthDay News) --
Heart disease, diabetes and depression can be a lethal triple-play -- boosting
a patient's death risk by 20 percent to 30 percent, new research shows.

"We do not know what this increased risk is due to, but it could either be
that depression influences crucial aspects of self-care behaviors needed to
manage diabetes or that a more severe disease process is reflected in more
depressive symptoms," said lead researcher Anastasia Georgiades, a
research associate in the department of psychiatry and behavioral science at Duke
University in Durham, N.C.

Georgiades was expected to present the findings Friday at the American
Psychosomatic Society annual meeting in Budapest, Hungary.

In their study, the Duke team followed 933 heart patients for more than four
years. During that time, there were 135 deaths among patients with type 2
diabetes and/or depression, the researchers found.

Among patients with moderate-to-severe symptoms of depression who were also
diabetics, the researchers observed a significant 30 percent greater risk of
dying over the four-year period compared with patients with either depression
alone or diabetes alone. Read more…

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Bipolar Kids May Focus on Different Facial Features

Posted: May 20, 2012 at 3:57 pm

(HealthDay News) --
Children with bipolar disorder and a similar condition called severe mood
dysregulation spend less time looking at the eyes when trying to identify
facial features, compared to children without the psychiatric disorders,
researchers say.

This new study finding may help explain why children with bipolar disorder and
severe mood dysregulation have difficulty determining other people's emotional
expressions, said the U.S. National Institute of Mental Health investigators.

The researchers tracked the eye movements of children with and without
psychiatric disorders as they viewed faces with different emotional
expressions, such as happy, sad, fearful and angry. In general, the children
spent more time looking at the eyes, the facial feature that conveys the most
information about emotion. Read more…

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Cell-based Cancer Immunotherapies. Some metrics..

Posted: May 20, 2012 at 3:57 pm

Tweet 


Whatever one makes of Dendreon's challenges in bringing Provenge to market and then its ups and downs in the market, the whole affair has brought a much bigger spotlight to cancer immunotherapies and cell-based immunotherapies in particular.

This is true on all fronts.  Cancer immunotherapy conferences are popping up everywhere.  A growing number of of analysts are now covering a growing number of companies in the space with coverage ranging from bearishly critical to ebullient bullishness. Some venture capital firms are now loosening their purse strings for immunotherapy plays and both pharma venture funds and business development departments are now spending an increasing amount of time actively monitoring and exploring potential plays in the sector.



One of the best annual industry summaries of what is happening in the sector is sponsored by MD Becker Partners through its annual Cancer Immunotherapy: A Long Awaited Reality conference held each in New York, this year on October 4 and select video replays it hosts on its YouTube channel.

Some Segment Metrics
As part of our ongoing industry intelligence and consulting services we actively track the activity and progress of industry-sponsored clinical trials of all cell therapies in addition to the products already on the market.  Here's how our data stacks up regarding the cell-based immunotherapies segment of the sector:
Commercial:
  • Dendreon's Provenge
    • Autologous immunotherapy for prostate cancer (1 monthly dose for 3 months)
    • Efficacy: prolongs survival
    • Markets: only the United States (approved April 2010)
    • Next markets: submitted the marketing authorisation application to the EMA (European Medicines Agency) in early 2012 and hopes to introduce Provenge in the European market in 2013
    • 2011 Revenue $290,000
    • Projected 2012 Revenue: ~$380,000

Phase III or II/III:

Phase II or I/II

  • 50 industry-sponsored clinical trials of cell-based immunotherapies actively recruiting, active no longer recruiting, active not yet recruiting, or anticipated to commence yet in 2012
    • ~10 of these are expected to have readouts yet this year
    • Trial sites in US, Canada, UK, continental Europe, Israel, South Korea, India, Australia
    • Expected enrollment of 3,500+
Investment:

The following are notable cash infusions into the sector for 2012 to-date:
  • Bellicum Pharmaceuticals.  $20M series B. 
  • CellMedica. $15M grant from CPRIT in Texas.
  • Argos Therapeutcs. $25M Series D.
  • Northwest Bio.  $5.5M grant from German gov't Saxony Development Bank

Hope this is useful.

--

This post has been brought to you by your friends at CTG.  All cell therapy. All the time. 🙂  

-- Lee @celltherapy

p.s.  As always we welcome your feedback, comments, and corrections.  












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Painful Decisions Coming Up at Stem Cell Agency

Posted: May 20, 2012 at 3:57 pm


The
Sacramento Bee today ran a piece by yours truly in its California
Forum section.

Here
is an excerpt. You can find the entire article here.

"They're
talking about pain at the $3 billion California stem
cell agency. And mortality. But not the end of life as you and I know
it.

"They're
talking about the pain that comes from cutting off millions of
dollars for scientists. They're talking about what will happen when
the state stops borrowing money to finance stem
cell research –
a final-breath moment that arrives in about five years....

"CIRM's
changing priorities create 'stark tension,' said one board
member, Michael Friedman, CEO of the City of Hope in the Los Angeles
area, in January. 'We're going to have to make some really
painful and difficult decisions,' he told directors.

"CIRM's
success – or lack of it – will play a critical role in its future
finances, whether they are based on another bond measure or private
support."

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

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San Diego Biotech Firm Appeals Rejection of Cancer Stem Cell Grant

Posted: May 20, 2012 at 3:57 pm


A San Diego biotech firm, Eclipse
Therapeutics, whose multimillion dollar grant application was
rejected by reviewers at the California stem cell agency, is asking
the agency's board to overturn the decision next Thursday.
Eclipse, a spinoff from
Biogen Idec, said it is reducing its request from $3.5 million
because it has raised $2 million since it applied for the grant six
months ago. However, its appeal did not state specifically how much
it was now requesting from CIRM. The research involves cancer stem cells.
The company's appeal said that
during the period following submission of its application, it has accomplished all of the activities that CIRM had identified
as the first milestone in the research project. Eclipse also said it
has accomplished a number of activities in milestones two and three.
The firm said that it is now accelerating its IND filing by one year.
Eclipse was formed in March 2011 with
$2 million in seed funding from City Hill Ventures, also of San
Diego, according to a Bioworld article by Marie Powers. The
co-founders are Peter Chu, now president of Eclipse, and Christopher
Reyes, chief scientific officer. Chu and Reyes ran Biogen Idec's
cancer stem cell program. They are also the applicants for the CIRM
grant.
Their appeal carried a routine cover
letter to the CIRM board from CIRM President Alan Trounson. He made
no comment on the worthiness of the request. On
an earlier appeal from Stuart Lipton of Sanford-Burnham, Trounson's
cover letter said Lipton's letter was "without merit."
Eclipse said its proposal received a
scientific score of 58 out of 100 from CIRM reviewers. CIRM, however, has not released the company's score. Two other proposals with scores of 53
were approved by reviewers.
For several years, CIRM has been
sharply criticized for its failure to fund businesses in a
significant way. It is currently moving to engage them more closely.
If Eclipse's appeal is successful, it will be one of less than 20
business to be funded without a nonprofit partner. Businesses have
received only about 4 percent of CIRM's $1.3 billion in awards to 494enterprises.
Appeals from rejected applicants
are included in the agenda material presented to the CIRM board, but
the board does not have to act on them or discuss them. Researchers
can also appear before the board to make a case.

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