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Dennis Steindler Application: Excerpt from Review Summary

Posted: September 9, 2012 at 3:57 pm


The CIRM summary of the review on the
$6.7 million grant to recruit Florida scientist Dennis Steindler to
the Parkinson's Institute in California carried a strong minority report. However, the review itself drew fire this morning from some CIRM board members.
They included patient advocate Jeff Sheehy, co-vice chair of the grant review group, who supported approval of the grant. He noted that the low score reflected two extreme opinions. He said some of the reviewers were doing their research on the Parkinson's Institute on the Internet during the actual review.  Sheehy said that was not a "good way" to perform a review and reflected a "major short-coming." 
Here is an excerpt from the review.

"In summary, this is an
application from an established leader in NSC biology to pursue
research focused on disease mechanisms in PD. Strengths of the
proposal include the quality of the PI, the focus of the project on
an interesting hypothesis, and the leadership in basic science that
the candidate would bring to the applicant institution. Weaknesses
included deficiencies in the research plan, the limited track-record
of the PI in PD research and an institutional environment lacking
adequate support for basic science investigations."

The summary continued, 

"During programmatic discussion some GWG (grant review group) members cited a need to broaden stem cell leadership not only at the
large universities but also at the smaller institutions as well. They
felt that the candidate's recruitment would strengthen the applicant
institution and provide leadership and strength in basic research.
The need for increased research focused on Parkinson's Disease was
also cited by some reviewers. A motion to recommend the application
for funding carried with a majority vote. Because more than 35% of
GWG members opposed the motion, opponents have exercised their right
to have that position reported to the ICOC. The consensus statement
from this group is as follows: 'Despite the facts that the
applicant has many excellent attributes, that Parkinson's disease is
a key area of interest, and that the applicant institution may
deserve additional consideration, our opinion is that the application
clearly falls short in several critical scientific areas that
outweigh the programmatic concerns and do not justify a
recommendation for funding. We believe that the people of California
depend upon us to make recommendations based on our scientific
expertise, for outcomes that are most likely to impact medicine and
the health and treatment of their citizens. We believe that their
money can be better spent.'"

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CIRM Board Eyes Florida Researcher for $6.7 Million Grant

Posted: September 9, 2012 at 3:57 pm


The board of the California stem cell agency is discussing a proposal to award $6.7 million to recruit a Florida scientist to the Parkinson's Institute in Sunnyvale, Ca.

The scientist is Dennis Steindler of the University of Florida. The recruitment award received a score of 57, although the scores ranged from 30 to 75.  Jeff Sheehy, a member of the grant review group and CIRM board member, said the score reflected two extremely divergent positions by two reviewers.

The board has awarded four grants in its recruitment round over the past couple of years, but this is the first extended discussion of an award recommended by reviewers. It is also the first to have a representative of the applicant institution speaking publicly for the grant.

CIRM directors have now moved into executive session to discuss matters they prefer to air in private.

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Two Additional Appeals Rejected in Disease Team Round

Posted: September 9, 2012 at 3:57 pm


The governing board of the California stem cell agency last night rejected appeals by two applicants -- OncoMed Pharmaceuticals of Redwood City and Albert Wong of Stanford -- in the $200 million disease team round.

Both petitions generated little discussion. You can find more on their petitions here and here.

The board also approved changes in its intellectual property and grant administration rules. Both proposals will now enter the state's official administrative law process for more comment and possible change.

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StemCells, Inc., Hails $40 Million in Awards from California Stem Cell Agency

Posted: September 9, 2012 at 3:57 pm


StemCells, Inc., was quick this morning
with a press release about winning a $20 million award last night from the
California stem cell agency.

The publicly traded, Newark, Ca., firm
also pointed out that the CIRM board in July awarded another $20
million to the business.
The news release hailed the awards as
validating its science and business. Martin McGlynn, who personally
appeared before the CIRM board last night, said,

 "CIRM's approval of two
awards to StemCells illustrates the tremendous promise of
our neural stem cell technology and the high degree of confidence in
the world class team of scientists and clinicians who will be working
to translate this technology into potential treatments and cures for
these devastating diseases." 

On the Alzheimer's award last night,
McGlynn said,

 "With the recent spate of late-stage clinical
failures in Alzheimer's disease, it is clear that the field could
benefit from alternative approaches to lessen the huge burden on
families, caregivers and our healthcare system.

He continued,

"Our recently reported preclinical
data, which showed that our neural stem cells restored memory and
enhanced synaptic function in two animal models relevant to
Alzheimer's disease, shows our approach has promise. We greatly
appreciate the support from CIRM, which should help us accelerate our
efforts to test our HuCNS-SC cells in Alzheimer's disease."

The news release did not note that the
board has required that the firm must show proof that it has access
to $20 million in matching funds prior to receiving cash from the
agency on the Alzheimer's grant. The California Stem Cell Report is
asking CIRM whether that requirement extends to the earlier grant as
well.
One of the analysts who follows the
company released a special report on the firm this morning. Stephen
Dunn of LifeTech Capital said,

 “We are reiterating our strong
speculative buy with a price target of $4.50 as StemCells Inc.
continues to distinguishing themselves as one of the most advanced
players in the stem cell space.”

At the time of this writing, the firm's
stock was trading at $2.20 up seven cents. Its 52 week high is $2.67
and its 52 week low is 59 cents.  

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StemCells, Inc., Wins Another $20 Million From California Stem Cell Agency

Posted: September 9, 2012 at 3:57 pm


Following a second impassioned pitch by its former chairman, Robert Klein, the governing board of the California stem cell agency approved a $20 million award to a financially strapped biotech firm, StemCells, Inc., of Newark, Ca.

Approval came on a 7-5 vote with the condition that the company demonstrate it has access to $20 million in matching funds prior to funding.  It is the second $20 million award that the company has received in the disease team round, which now totals $214 million. Another disease team application has been tabled and will not be considered until October.

The current CIRM chairman, J.T. Thomas, a Los Angeles bond financier, asked for the financial proof because he said some concerns were expressed during an executive session that CIRM would now "account for such a large part of the assets of the company." Martin McGlynn, CEO of StemCells, Inc., also told the board that the company might have to drop its Alzheimer's research if it did not receive the CIRM award.

The StemCells, Inc., application was rejected twice by reviewers. The original rejection came before the July meeting at which Klein first appeared (see here and here). The proposal was then sent back for re-review, during which it was rejected again.

However, the 29-member board narrowly approved the application following discussion tonight and following its rejection of another Alzheimer's research proposal from USC. Both applicants produced a number of witnesses, including patients, on behalf of their appeals.

The re-review on the StemCells, Inc., application said in reference to a statement by Klein to board in July,

“The reviewers did not feel there was compelling data for neuron migration in the submitted manuscript. This is the manuscript specifically referenced at the ICOC (CIRM governing board) meeting (in July) that prompted the call for additional analysis. The manuscript is not yet accepted, it is 'potentially acceptable' but requires 'major revisions' according to the journal editor note. In addition, however, the studies in this manuscript used mouse NSCs, not the human NSCs proposed for the disease team award....”

In July, Klein said, “....(W)e have brand-new data that demonstrates and totally contradicts the key weakness on which it was downgraded.” 

A footnote: The CIRM staff said that as a result of two StemCells application, a proposal is being prepared to limit applications to one per entity in later rounds.

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Stem cells from blood may banish wrinkles

Posted: September 9, 2012 at 10:10 am

The ability of the body to produce this elastic material slows down with age because the number of these fibroblasts decrease.

By introducing large numbers of stem cells into the right place, we are increasing the ability of the body to produce this material. It is still in its early stages but we hope to begin phase one trials within the next 12 months.

Until recently, anyone hoping to get rid of their wrinkles had to rely on cosmetic treatments that injected synthetic collagen under the skin as a filler to remove the lines.

Botox has now become popular for cosmetic treatments, where a neurotoxin from the bacteria Clostridium botulinum is injected to immobilise the muscles that can cause wrinkles.

Fibroblast cells produce collagen and help maintain the skins structural integrity.

Pharmacells, which will be conducting its first clinical trial with a clinic in Hong Kong, uses a technique to purify an unspecialised type of cell, known as blastocyst-like stem cells, which can develop into many different types of tissues in the body.

It will be the first therapy to use this type of cell and the company also hopes to develop new techniques to treat diseases such as heart disease and osteoarthritis.

Rajiv Grover, a plastic surgeon and president elect of the British Association of Aesthetic Plastic Surgeons, said it could be five to 10 years before stem cell treatments for wrinkles were widely available.

It is an exciting prospect as the science of stem cells will influence plastic surgery and cosmetic medicine significantly in the future, he said.

There is some evidence stem cells, when injected, can improve skin quality, but until you have had studies that look at the long-term effect and the safety, you cannot be sure.

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Gloria Arroyo to have stem cell treatment Monday

Posted: September 8, 2012 at 3:11 am

Former President and now Pampanga Rep. Gloria Macapagal-Arroyo will undergo stem cell therapy on Monday with an alternative medicine doctor.

Arroyo, in a post on her Twitter account Saturday morning, said Monday's session will be her fourth intravenous treatment.

"This Monday I will have my fourth stem cell intravenous treatment with my alternative medicine doctor," she said.

Also she said, "It's cultured stem cell and much more modest in price than the one coming from sheep or one's own body."

But she did not elaborate on how much the treatment will cost.

Stem cell therapy is type of intervention strategy that introduces new adult stem cells into damaged tissue in order to treat disease or injury.

Earlier this week, Arroyo said she continues to search for alternative solutions to an anatomic problem that prompted her to be rushed to a government hospital last month.

Arroyo said she had seen at least two "alternative medicine practitioners," and has initiated communication with a "neurocervical spine purist."

She said she also had her thrice-weekly therapy at the Veterans Memorial Medical Center (VMMC) in Quezon City Thursday.

Arroyo underwent treatment last August for an anatomic problem that caused her to choke on her food.

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Verastem to Present on Focal Adhesion Kinase Program at the 11th International Conference of the International …

Posted: September 7, 2012 at 7:21 pm

CAMBRIDGE, Mass.--(BUSINESS WIRE)--

Verastem, Inc., (VSTM) a biopharmaceutical company focused on discovering and developing drugs to treat breast and other cancers by targeting cancer stem cells, announced the presentation of data at theInternational Conference of the International Mesothelioma Interest Group being heldSeptember 11 15, 2012, inBoston, MA.

Verastemwill present data on the targeted inhibition of Focal Adhesion Kinase (FAK) in mesothelioma. Approximately 50% of patients with mesothelioma harbor a specific genetic lesion in the gene Neurofibromatosis Type 2 (NF2), which results in the loss of the protein Merlin and increased sensitivity to FAK inhibition.

In Merlin-negative mesothelioma, we have demonstrated that the proportion of cancer stem cells increases in response to treatment with the standard of care agent pemetrexed, said Jonathan Pachter, Ph.D., Verastem Vice President and Head of Research. In striking contrast, we have found that these cancer stem cells are particularly sensitive to targeted FAK inhibition. This translational research provides valuable information for the design of our upcoming clinical trials.

The schedule for theVerastemposter presentation is as follows:

Date:Wednesday, September 12, 2012, 11:30 AM 12:30 PM (ET) Poster Title:FAK inhibitor VS-4718 preferentially attenuates cell growth of malignant mesotheliomas with NF2 mutation: role of cancer stem cells Abstract Number:407 Location:Harborview Ballroom at the Seaport Hotel and World Trade Center in Boston, MA Session: Novel Therapeutics

AboutVerastem, Inc.

Verastem, Inc.(VSTM) is a biopharmaceutical company focused on discovering and developing drugs to treat breast and other cancers by targeting cancer stem cells. Cancer stem cells are an underlying cause of tumor recurrence and metastasis. For more information please visitwww.verastem.com.

Forward-looking statements:

This press release includes forward-looking statements about the Companys strategy, future plans and prospects, including statements regarding the development of the Companys compounds and the Companys FAK and diagnostic programs generally. The words anticipate, believe, estimate, expect, intend, may, plan, predict, project, target, potential, will, would, could, should, continue, and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include the risks that the preclinical testing of the Companys compounds may not be predictive of the success of later clinical trials, that the Company will be unable to successfully complete the clinical development of its compounds, including VS-6063 and VS-4718, that the development of the Companys compounds will take longer or cost more than planned, and that the Companys compounds will not receive regulatory approval or become commercially successful products. Other risks and uncertainties include those identified under the heading Risk Factors in the Companys Annual Report on Form 10-K for the year ended December 31, 2011 and in any subsequent SEC filings. The forward-looking statements contained in this presentation reflect the Companys current views with respect to future events, and the Company does not undertake and specifically disclaims any obligation to update any forward-looking statements.

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Cedars-Sinai Heart Institute awarded $1.3 million to study cardiac stem cells

Posted: September 7, 2012 at 7:21 pm

Public release date: 6-Sep-2012 [ | E-mail | Share ]

Contact: Sally Stewart Sally.stewart@cshs.org 310-248-6566 Cedars-Sinai Medical Center

LOS ANGELES Sept. 6, 2012 A team of Cedars-Sinai Heart Institute stem cell researchers today was awarded a $1.3 million grant from the California Institute of Regenerative Medicine to continue study of an experimental stem cell therapy that treats heart attack patients with heart-derived cells. Earlier this year, data from the first clinical trial of the stem cell treatment showed the therapy helped damaged hearts regrow healthy muscle.

To date, this cell therapy, developed by Eduardo Marbn, MD, PhD, director of the Cedars-Sinai Heart Institute and Mark S. Siegel Family Professor, is the only treatment shown to regenerate the injured human heart. In this therapy, human heart tissue is used to grow specialized heart stem cells, which then are injected back into the patient's heart. The new research will focus on understanding the cellular mechanisms that have produced favorable outcomes.

"We have seen encouraging results in patients with this treatment, and it has the potential to revolutionize how we treat heart attack patients," Marbn said. "This further study will allow us to better understand how it works, which we hope will lead us to even more stem-cell based treatments for the heart."

During a heart attack, clots form suddenly on top of cholesterol-laden plaques, which block the flow of blood to the heart muscle. This causes living heart tissue to die and be replaced by a scar. The larger the scar, the higher the chance of death or disability from the heart attack.

Conventional treatments aim to limit the initial injury by opening the clogged artery and prevent further harm with medications. Regenerative therapy aims to regrow healthy heart muscle and dissolve the heart tissue -- an approach that, according to a study by Marbn published in The Lancet, led to an average 50 percent reduction in scar size.

Early study by Cedars-Sinai researchers indicates that much of the benefit in the experimental therapy is due to an indirect effect of the transplanted cardiac-derived cells. These cells seem to stimulate proliferation of the surrounding undamaged heart cells -- a previously unrecognized means of cardiac regeneration in response to cell therapy.

"This is vital basic science work that we believe will ultimately open pathways to new treatments in the fight against heart disease, the leading cause of premature death and disability," Marbn said.

The process to grow the cardiac-derived stem cells involved in the study was developed by Marbn when he was on the faculty of Johns Hopkins University. The university has filed for a patent on that intellectual property, and has licensed it to a company in which Dr. Marbn has a financial interest.

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CIRM Funds Six UC San Diego Stem Cell Researchers

Posted: September 7, 2012 at 7:21 pm

Newswise The governing board of the California Institute for Regenerative Medicine (CIRM) has announced that six investigators from the University of California, San Diego Stem Cell Research program have received a total of more than $7 million in the latest round of CIRM funding. This brings UC San Diegos total to more than $128 million in CIRM funding since the first awards in 2006.

UC San Diego scientists funded by the newly announced CIRM Basic Biology Awards IV include Maike Sander, MD, professor of Pediatrics and Cellular and Molecular Medicine; Miles Wilkinson, PhD, professor, Division of Reproductive Endocrinology; Gene Yeo, PhD, MBA, assistant professor with the Department of Cellular and Molecular Medicine and the Institute for Genomic Medicine; George L. Sen, PhD, assistant professor of cellular and molecular medicine; David Traver, PhD, associate professor with the Department of Cellular and Molecular Medicine and Ananda Goldrath, PhD, associate professor in the Division of Biological Sciences.

Sander was awarded nearly $1.4 million for her proposal to define and characterize the key transcription factors necessary to promote maturation of human embryonic stem cell (hESC)-derived pancreatic progenitors into mature insulin-secreting beta cells. The loss of pancreatic beta cells in type 1 diabetes results in the absence of insulin secreted by the pancreas. The goal of this work is to enable scientists to one day produce an unlimited source of transplantable beta-cells for patients with diabetes.

Wilkinsons grant of $1.36 million will allow his lab to develop and test induced pluripotent stem cells (iPS cells) from patients with genetic mutations in a component of the pathway that results in intellectual disabilities. Many of these patients also have autism, attention-deficit disorders or schizophrenia. Directed towards understanding fundamental mechanisms by which all stem cells are maintained, his research has the potential to impact non-psychiatric disorders as well.

A grant of almost $1.4 million will fund Yeos research to help decode the mechanisms that underlie the single most frequent genetic mutation found to contribute to neurodegenerative diseases amyotrophic lateral sclerosis (ALS or Lou Gehrigs disease) and frontotemporal dementia (FTD). Yeo will generate iPSCs and differentiated motor neurons derived from patients with these mutations, then use genome-wide technologies to analyze these and normal cells and test strategies to rescue mutation-induced defects in iPSC-derived motor neurons.

Sen received a grant of just over $1 million to investigate how tissue specific stem and progenitor cells exist to replenish both healthy, normal tissue and for regeneration from a wound. Disease and aging deplete stem and progenitor cells, impeding the bodys ability to regenerate itself. Sens work aims to better understand the mechanisms of self-renewal and differentiation in epidermal (skin) stem cells. Imbalanced growth and differentiation of epidermal cells can lead to a variety of human skin disorders, including psoriasis and cancer.

Traver, who was awarded a CIRM grant of more than $1.3 million in collaboration with Thierry Jaffredo of the Universit Pierre et Marie Curie in Paris, studies hematopoietic stem cells. HSCs are rare, multipotent stem cells that give rise to all blood cell types, including red blood and immune cells. Travers lab investigates the genes and signaling pathways used by vertebrate embryos to create the first HSCs. An understanding of this developmental process has implications for producing restorative stem cell-based therapies for diseases like leukemia and congenital blood disorders. Currently, medical treatments using HSCs are hampered by cell shortages and finding compatible matches between donors and recipients.

Goldraths $1.16 million grant will help develop strategies to induce immunological tolerance to hESC-derived tissues and cells. Immune-mediated rejection of hESC-derived tissues remains a significant barrier to the promise of regenerative therapies. She proposes a novel approach to promote long-term acceptance of hESC-derived tissues by exploring the molecular pathways and immune cell types that mediate the induction of immune tolerance and pursuing additional targets that halt rejection of tissue grafts derived from these stem cells. If successful, this would increase the potential reach of cellular therapies by decreasing the undesirable side effects of generalized immune suppression.

The CIRM Basic Biology Awards are designed to fund investigations into the basic mechanisms underlying stem cell biology, cellular plasticity, and cellular differentiation. These awards will also fund the development and use human stem cell based models for exploring disease. According to CIRM, studies supported by these awards will form the foundation for future translational and clinical advances, enabling the realization of the full potential of human stem cells and reprogrammed cells for therapies and as tools for biomedical innovation.

CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure provided $3 billion in funding for stem cell research at California universities and research institutions and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities.

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