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Category Archives: Stem Cell Therapy

Stem cell therapies for multiple sclerosis, other myelin disorders expected soon

Posted: October 28, 2012 at 6:40 am

ScienceDaily (Oct. 25, 2012) When the era of regenerative medicine dawned more than three decades ago, the potential to replenish populations of cells destroyed by disease was seen by many as the next medical revolution. However, what followed turned out not to be a sprint to the clinic, but rather a long tedious slog carried out in labs across the globe required to master the complexity of stem cells and then pair their capabilities and attributes with specific diseases.

In a review article appearing October 25 in the journal Science, University of Rochester Medical Center scientists Steve Goldman, M.D., Ph.D., Maiken Nedergaard, Ph.D., and Martha Windrem, Ph.D., contend that researchers are now on the threshold of human application of stem cell therapies for a class of neurological diseases known as myelin disorders -- a long list of diseases that include conditions such as multiple sclerosis, white matter stroke, cerebral palsy, certain dementias, and rare but fatal childhood disorders called pediatric leukodystrophies.

"Stem cell biology has progressed in many ways over the last decade, and many potential opportunities for clinical translation have arisen," said Goldman. "In particular, for diseases of the central nervous system, which have proven difficult to treat because of the brain's great cellular complexity, we postulated that the simplest cell types might provide us the best opportunities for cell therapy."

The common factor in myelin disorders is a cell called the oligodendrocyte. These cells arise, or are created, by another cell found in the central nervous system called the glial progenitor cell. Both oligodendrocytes and their "sister cells" -- called astrocytes -- share this same parent and serve critical support functions in the central nervous systems.

Oligodendrocytes produce myelin, a fatty substance that insulates the fibrous connections between nerve cells that are responsible for transmitting signals throughout the body. When myelin-producing cells are lost or damaged in conditions such as multiple sclerosis and spinal cord injury, signals traveling between nerves are weakened or even lost. Astrocytes also play an essential role in the brain. Long overlooked and underappreciated, it is now understood that astrocytes are critical to the health and signaling function of oligodendrocytes as well as neurons.

Glial progenitor cells and their offspring represent a promising target for stem cell therapies, because -- unlike other cells in the central nervous system -- they are relatively homogeneous and more readily manipulated and transplanted. In the case of oligodendrocytes, multiple animal studies have shown that, once transplanted, these cells will disperse and begin to repair or "remyelinate" damaged areas.

"Glial cell dysfunction accounts for a broad spectrum of diseases, some of which -- like the white matter degeneration of aging -- are far more prevalent than we previously realized," said Goldman. "Yet glial progenitor cells are relatively easy to work with, especially since we don't have to worry about re-establishing precise point to point connections as we must with neurons. This gives us hope that we may begin to treat diseases of glia by direct transplantation of competent progenitor cells."

Scientists have reached this point, according to the authors, because of a number of key advances. Better imaging technologies -- namely advanced MRI scanners -- now provide greater insight and clarity into the specific damage caused in the central nervous system by myelin disorders. These technologies also enable scientists to precisely follow the results of their work.

Even more importantly, researchers have overcome numerous obstacles and made significant strides in their ability to manipulate and handle these cells. Goldman's lab in particular has been a pioneer in understanding the precise chemical signals necessary to coax stem cells into making glial progenitor cells, as well as those needed to "instruct" these cells to make oligodendrocytes or astrocytes. His lab has been able to produce these cells from a number of different sources -- including "reprogramming" skin cells, a technology that has the advantage of genetically matching transplanted cells to the donor. They have also developed techniques to sort these cells based on unique identifying markers, a critical step that ensures the purity of the cells used in transplantation, lowering the risk for tumor formation.

Nedergaard's lab has studied the integration of these cells into existing neural networks, and well as in imaging their structure and function in the adult nervous system. Together, the two labs have developed models of both human neural activity and disease based on animals transplanted with glial progenitor cells, which will enable human neural cells to be evaluated in the context of the live adult brain -- as opposed to a test tube. This work has already opened new avenues in both modeling and potentially treating human glial disease.

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Stem cell therapies for multiple sclerosis, other myelin disorders expected soon

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ViaCyte Receives $10.1 Million Strategic Partnership Award from CIRM to Continue Development of Diabetes Therapy

Posted: October 28, 2012 at 6:40 am

SAN DIEGO, Oct. 26, 2012 /PRNewswire/ --ViaCyte, Inc., a leading regenerative medicine company developing a transformative cell therapy for treatment of diabetes, announced today that it has received a $10.1 million Strategic Partnership Award from the California Institute for Regenerative Medicine (CIRM).

(Logo: http://photos.prnewswire.com/prnh/20121026/LA00871LOGO-a)

(Logo: http://photos.prnewswire.com/prnh/20121026/LA00871LOGO-b)

ViaCyte's innovative stem cell-based therapy for diabetes has been supported by several previous rounds of funding from CIRM, including a $20 million Disease Team Award in 2009. This support has directly aided the development of VC-01, a regenerative medicine, combination product consisting of pancreatic beta cell progenitors encapsulated in a durable macroencapsulation device. When implanted under the skin of a patient with diabetes, VC-01 is expected to produce insulin and other factors which should safely and effectively control their disease. In its review of ViaCyte's application, CIRM's Grants Working Group characterized the Company's proposed therapy as the "holy grail" of diabetes treatments.

ViaCyte recently held a successful Pre-IND meeting with the United States Food and Drug Administration (FDA) and is on track to file an Investigational New Drug (IND) Application and initiate clinical evaluation of VC-01 in 2014. The Strategic Partnership Award from CIRM will be used to support these efforts, reflecting CIRM's commitment to following promising science through the progressive stages of product development.

"We are very grateful for the assistance that we are receiving from CIRM to advance our promising technology", stated Dr. Paul Laikind, President and CEO of ViaCyte. "Today's grant allows us to continue our efforts on behalf of the California taxpayers to break new ground with our stem cell-based product that has the potential to essentially cure patients with type 1 diabetes and provide a powerful new treatment for those with type 2 disease as well."

Approval of the award came from CIRM's governing board, the Independent Citizens Oversight Committee (ICOC), with advisement from the Scientific and Medical Research Funding Working Group. "ViaCyte has made good on their initial Disease Team award from CIRM, including a successful Pre-IND FDA meeting, and as a consequence, CIRM and the ICOC are glad to have the opportunity to continue funding ViaCyte's efforts to provide this product to patients with diabetes in California and the rest of the world," said Dr. Alan Trounson, President of CIRM.

About ViaCyte

ViaCyte is a private company focused on developing a novel cell therapy for the treatment of diabetes. The Company's technology is based on the production of pancreatic beta cell progenitors derived from human pluripotent stem cells. These cells are implanted using a durable and retrievable encapsulation device. Once implanted and matured, these cells secrete insulin and other regulatory factors in response to blood glucose levels. ViaCyte's goal is long term insulin independence without immune suppression, and without risk of hypoglycemia and other diabetes-related complications.

ViaCyte is headquartered in San Diego, California with additional operations in Athens, Georgia. The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF.

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ViaCyte Receives $10.1 Million Strategic Partnership Award from CIRM to Continue Development of Diabetes Therapy

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BioTime Makes Bid for Geron’s Stem Cell Assets

Posted: October 21, 2012 at 7:59 am


Biotime, Inc., and two men who were
leading players in history of Geron Corp. today made a surprise,
public bid for the stem cell assets of their former firm.

Michael West
West photo
Tom Okarma
AP file photo
The men are Michael West and Thomas
Okarma. West founded Geron in 1990 and was its first CEO. West is
now CEO of Biotime. Okarma was CEO of Geron from 1999 to 2011.
Okarma joined Biotime on Sept. 28 to lead its acquistion efforts.
Both Geron, based in Menlo Park, Ca., and Biotime, based in Alameda,
Ca., are publicly traded.
West and Okarma sent an open letter this morning to Geron shareholders and issued a press release making
a pitch for the Geron's stem cell assets. Geron jettisoned its hESC
program nearly a year ago and closed its clinical trial program for
spinal injuries. The move shocked the California stem cell agency,
which just a few months earlier had signed an agreement to loan the
firm $25 million to help fund the clinical trial. The portion of the
loan that was distributed was repaid with interest.
At the time, Geron said it would try to
sell off the hESC program, but no buyers have surfaced publicly.
Personnel in the program have been laid off or found employment
elsewhere.
The West-Okarma letter to shareholders
said that under the deal,

“Geron would transfer its stem cell
assets to BAC(a new subsidiary of Biotime headed by Okarma), in
exchange for which you along with the other Geron shareholders would
receive shares of BAC common stock representing approximately 21.4%
of the outstanding BAC capital stock. BioTime would contribute to BAC
the following assets in exchange for the balance of outstanding BAC
capital stock:

  • “$40 million in BioTime common
    shares;
  • “Warrants to purchase BioTime
    common shares (“BioTime Warrants”);
  • “Rights to certain stem cell
    assets of BioTime, and shares of two BioTime subsidiaries engaged in
    the development of therapeutic products from stem cells.”
The letter asked Geron shareholders to
write the firm's board of directors to urge them to approve the
offer.
Geron had no immediate response to the
proposal. Asked for comment, Kevin McCormack, spokesman for the
California stem cell agency, said the deal “had nothing to do with
us.” However, in the past, CIRM has indicated that it could find a
way to transfer the loan to an entity that would continue spinal
injury clinical trial. CIRM President Alan Trounson was also involved
at one point in trying to assist in a deal.
Geron's shares rose 12 cents to $1.54
today while Biotime's shares lost four cents to $3.95.
Here are links to the two news stories
that have appeared so far on the proposed deal: Associated Press, Marketwatch.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/v1bas6eGZF0/biotime-makes-bid-for-gerons-stem-cell.html

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California Stem Cell Agency Boosting Disease Team Program to $543 Million

Posted: October 21, 2012 at 7:59 am


Directors of the California stem cell
agency are set to give away $20 million next Thursday and authorize
a handsome addition to their signature disease team effort, bringing
its total to $543 million.

It is all part of the $3 billion
agency's push to develop therapies prior to running out of money for
new grants in 2017.
The $20 million is expected to go to
the first two winners in the agency's new strategic partnership
program. CIRM says the effort is aimed at
creating “incentives and processes that will: (i) enhance the
likelihood that CIRM funded projects will obtain funding for Phase
III clinical trials (e.g. follow-on financing), (ii) provide a source
of co-funding in the earlier stages of clinical development, and
(iii) enable CIRM funded projects to access expertise within
pharmaceutical and large biotechnology partners in the areas of
discovery, preclinical, regulatory, clinical trial design and
manufacturing process development.”
CIRM reviewed six applications with two winning approval. The agency's governing board is expected to ratify the decision next week. None of the applicants have been identified by the agency, which routinely withholds that information prior to
board action even when applicants have identified themselves.
Addition of a new $100 million
disease team round will come on top of the second, $213 million disease
team awards approved last this summer. The first round, awarded in
2009, totaled $230 million.  The size of the new round could be altered by CIRM directors prior to approval. Also before the board is a $40 million
proposal to expand the industry-friendly strategic partnership effort
into a second round.
The thrust of the disease team effort
is to speed the process of establishing clinical trials and to finance
efforts that might founder in what the biotech industry calls a
valley of death – a high risk financial location, so to speak,
where conventional financiers fear to tread.
The new disease team round will require
“co-funding” from applicants but the agency did not specify what
it means by the term. The matter of matching funds has become an issue in awards to StemCells, Inc., of Newark, Ca., in this summer's
disease team round.
Next week's agenda additionally
contains a plan to tighten review of proposed research budgets in
grant applications, making it clear that CIRM staff will be
negotiating such matters even after the board approves grants and
loans.
So far no researchers have testified in
public on the budget plan although it could well have a significant
impact on their future efforts.
Additional matters will discussed as
well at the meeting in Burlingame, which also has a teleconference
location in La Jolla that will be open to the public. The address
and additional material can be found on the agenda.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/1gFmBSDEYCU/california-stem-cell-agency-boosting.html

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Los Angeles Times: StemCells, Inc., Award ‘Redolent of Cronyism’

Posted: October 21, 2012 at 7:59 am


The Los Angeles Times this
morning carried a column about the “charmed relationship” between
StemCells, Inc., its “powerful friends” and the $3 billion
California stem cell agency.

The article was written by
Pulitzer prize winner and author Michael Hiltzik, who has been
critical of the agency in the past. The piece was the first in the major
mainstream media about a $20 million award to StemCells, Inc., that was approved in September by the agency's board. The bottom line of the
article? The award was “redolent of cronyism.”
Hiltzik noted that
StemCells, Inc., now ranks as the leading corporate recipient of cash
from the agency with $40 million approved during the last few months.
But he focused primarily
on September's $20 million award, which was approved despite being
rejected twice by grant reviewers – “a particularly
impressive” performance, according to Hiltzik. It was the first
time that the board has approved an award that was rejected twice by
reviewers.
Hiltzik wrote,

“What was the company's
secret? StemCells says it's addressing 'a serious unmet medical need'
in Alzheimer's research. But it doesn't hurt that the company also
had powerful friends going to bat for it, including two guys who were
instrumental in getting CIRM off the ground in the first place.”

The two are Robert Klein,
who led the ballot campaign that created the agency and became its
first chairman, and Irv Weissman of Stanford, who co-founded
StemCells, Inc., and sits on its board. Weissman, an internationally
known stem cell researcher, also was an important supporter of the
campaign, raising millions of dollars and appearing in TV ads. Klein,
who left the agency last year, appeared twice before the CIRM board
this summer to lobby his former colleagues on behalf of Weissman's
company. It was Klein's first appearance before the board on behalf
of a specific application.
The Times piece continued,

“But private enterprise
is new territory for CIRM, which has steered almost all its grants
thus far to nonprofit institutions. Those efforts haven't been
trouble-free: With some 90% of the agency's grants having gone to
institutions with representatives on its board, the agency has long
been vulnerable to charges of conflicts of interest. The last thing
it needed was to show a similar flaw in its dealings with private
companies too.”

Hiltzik wrote,

“(Weissman) has also
been a leading beneficiary of CIRM funding, listed as the principal
researcher on three grants worth a total of $24.5 million. The agency
also contributed $43.6 million toward the construction of his
institute's glittering $200-million research building on the Stanford
campus.”

CIRM board approval of the
$20 million for StemCells, Inc., came on 7-5 vote that also required
the firm to prove that it had a promised $20 million in matching
funds prior to distribution of state cash.
Hiltzik continued,

“The problem is that
StemCells doesn't have $20 million in spare funds. Its quarterly
report for the period ended June 30 listed about $10.4
million in liquid assets, and shows it's burning about $5 million per
quarter. Its prospects of raising significant cash from investors
are, shall we say, conjectural.

“As it happens, within
days of the board's vote, the
firm downplayed any pledge 'to raise a specific amount of
money in a particular period of time.' The idea that CIRM 'is
requiring us to raise $20 million in matching funds' is a
'misimpression,' it said. Indeed, it suggested that it might count
its existing spending on salaries and other 'infrastructure and
overhead' as part of the match. StemCells declined my request that it
expand on its statement. 

“CIRM spokesman Kevin
McCormack says the agency is currently scrutinizing StemCells'
finances 'to see what it is they have and whether it meets the
requirements and expectations of the board.' The goal is to set
'terms and conditions that provide maximum protection for taxpayer
dollars.' He says, 'If we can't agree on a plan, the award will
not be funded.'"

Hiltzik wrote,

“The agency shouldn't be
deciding on the spot what does or doesn't qualify as matching funds.
It should have clear guidelines in advance.

“Nor should the board
overturn the judgment of its scientific review panels without
clear-cut reasons....The record suggests that the handling of the
StemCells appeal was at best haphazard and at worst redolent of
cronyism.” 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/6qvBfSLP3RE/los-angeles-times-stemcells-inc-award.html

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Researcher Alert: Stem Cell Agency to Take Up Grant Appeal Restrictions

Posted: October 21, 2012 at 7:59 am


The move by the $3 billion California
stem cell agency to curtail its free-wheeling grant appeal process
will undergo its first public hearing next week.

The proposals will mean that scientists
whose applications are rejected by reviewers will have fewer avenues
to pursue to overturn those decisions. The changes could take effect
as early as next year.
The move comes in the wake of a record
number of appeals this summer that left the board complaining about
“arm-twisting,” lobbying and “emotionally charged presentations.”
Among other things, the new "guidelines" attempt to define
criteria for re-review – “additional analysis” – of
applications involved in appeals, also called “extraordinary
petitions.” The plan states that re-review should occur only in
the case of a material dispute of fact or material new information.
(See the end of this item for agency's proposed definitions.)
In addition to alterations in the
appeal process, the CIRM directors' Application Review Task Force
will take up questions involving “ex parte communications.” The
agenda for the Oct. 24 meeting did not contain any additional
information on the issue but it likely deals with lobbying efforts on
grants outside of public meetings of the agency. We understand that
such efforts surfaced last summer involving the $$214 million disease
team round and Robert Klein, the former chairman of the stem cell
agency.
Klein appeared twice publicly before
the board on one, $20 million application by StemCells, Inc., the
first time a former governing board member has publicly lobbied his former
colleagues on an application. The application was rejected twice by reviewers – once
on the initial review and again later on a re-review – but it was
ultimately approved by directors in September on a 7-5 vote.
The board has long been troubled with
its appeal process but last summer's events brought the matter to a
new head. The issue is difficult to deal with because state law
allows anyone to address the CIRM governing board on any subject when
it meets. That includes applicants who can ask the board to approve
grants for any reason whatsoever, not withstanding CIRM rules. The board can also approve a grant
for virtually any reason although it has generally relied on
scientific scores from reviewers.
The proposals to restrict appeals are
designed to make it clear to scientists whose applications are
rejected by reviewers that the board is not going to look with favor
on those who depart from the normal appeals procedure.
While the board almost never has
overturned a positive decision by reviewers, in nearly every round it  approves some applications that have been rejected by reviewers. That has
occurred as the result of appeals and as the result of motions by
board members that did not result from public appeals.
Ten of the 29 board members are classified as patient advocates and often feel they must advance the cause of the
diseases that they have been involved with. Sometimes that means
seeking approval of applications with low scientific scores.
Here is how agency proposes to define
“material dispute of fact:”

“A material dispute of fact should
meet five criteria:(1) An applicant disputes the accuracy of a
statement in the review summary;(2) the disputed fact was significant
in the scoring or recommendation of the GWG(grant review group); (3) the dispute pertains
to an objectively verifiable fact, rather than a matter of scientific
judgment or opinion;(4) the discrepancy was not addressed through the
Supplemental Information Process and cannot be resolved at the
meeting at which the application is being considered; and
(5) resolution of the dispute could affect the outcome of the board’s
funding decision."

Here is how the agency proposes to
define “material new information:”

“New information should: (1)be
verifiable through external sources; (2) have arisen since the
Grants Working Group(grant review group) meeting at which the application
was considered; (3) respond directly to a specific criticism or
question identified in the Grants Working Group’s review; and (4)
be submitted as part of an extraordinary petition filed five business
days before the board meeting at which the application is
being considered."

Next week's hearing is scheduled for
Children's Hospital in Oakland with a teleconference location at UC
Irvine. Addresses can be found on the agenda.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/6sbxGqQJ77Y/researcher-alert-stem-cell-agency-to.html

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BioTime Makes Bid for Geron's Stem Cell Assets

Posted: October 21, 2012 at 7:57 am


Biotime, Inc., and two men who were
leading players in history of Geron Corp. today made a surprise,
public bid for the stem cell assets of their former firm.

Michael West
West photo
Tom Okarma
AP file photo
The men are Michael West and Thomas
Okarma. West founded Geron in 1990 and was its first CEO. West is
now CEO of Biotime. Okarma was CEO of Geron from 1999 to 2011.
Okarma joined Biotime on Sept. 28 to lead its acquistion efforts.
Both Geron, based in Menlo Park, Ca., and Biotime, based in Alameda,
Ca., are publicly traded.
West and Okarma sent an open letter this morning to Geron shareholders and issued a press release making
a pitch for the Geron's stem cell assets. Geron jettisoned its hESC
program nearly a year ago and closed its clinical trial program for
spinal injuries. The move shocked the California stem cell agency,
which just a few months earlier had signed an agreement to loan the
firm $25 million to help fund the clinical trial. The portion of the
loan that was distributed was repaid with interest.
At the time, Geron said it would try to
sell off the hESC program, but no buyers have surfaced publicly.
Personnel in the program have been laid off or found employment
elsewhere.
The West-Okarma letter to shareholders
said that under the deal,

“Geron would transfer its stem cell
assets to BAC(a new subsidiary of Biotime headed by Okarma), in
exchange for which you along with the other Geron shareholders would
receive shares of BAC common stock representing approximately 21.4%
of the outstanding BAC capital stock. BioTime would contribute to BAC
the following assets in exchange for the balance of outstanding BAC
capital stock:

  • “$40 million in BioTime common
    shares;
  • “Warrants to purchase BioTime
    common shares (“BioTime Warrants”);
  • “Rights to certain stem cell
    assets of BioTime, and shares of two BioTime subsidiaries engaged in
    the development of therapeutic products from stem cells.”
The letter asked Geron shareholders to
write the firm's board of directors to urge them to approve the
offer.
Geron had no immediate response to the
proposal. Asked for comment, Kevin McCormack, spokesman for the
California stem cell agency, said the deal “had nothing to do with
us.” However, in the past, CIRM has indicated that it could find a
way to transfer the loan to an entity that would continue spinal
injury clinical trial. CIRM President Alan Trounson was also involved
at one point in trying to assist in a deal.
Geron's shares rose 12 cents to $1.54
today while Biotime's shares lost four cents to $3.95.
Here are links to the two news stories
that have appeared so far on the proposed deal: Associated Press, Marketwatch.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/v1bas6eGZF0/biotime-makes-bid-for-gerons-stem-cell.html

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Los Angeles Times: StemCells, Inc., Award 'Redolent of Cronyism'

Posted: October 21, 2012 at 7:57 am


The Los Angeles Times this
morning carried a column about the “charmed relationship” between
StemCells, Inc., its “powerful friends” and the $3 billion
California stem cell agency.

The article was written by
Pulitzer prize winner and author Michael Hiltzik, who has been
critical of the agency in the past. The piece was the first in the major
mainstream media about a $20 million award to StemCells, Inc., that was approved in September by the agency's board. The bottom line of the
article? The award was “redolent of cronyism.”
Hiltzik noted that
StemCells, Inc., now ranks as the leading corporate recipient of cash
from the agency with $40 million approved during the last few months.
But he focused primarily
on September's $20 million award, which was approved despite being
rejected twice by grant reviewers – “a particularly
impressive” performance, according to Hiltzik. It was the first
time that the board has approved an award that was rejected twice by
reviewers.
Hiltzik wrote,

“What was the company's
secret? StemCells says it's addressing 'a serious unmet medical need'
in Alzheimer's research. But it doesn't hurt that the company also
had powerful friends going to bat for it, including two guys who were
instrumental in getting CIRM off the ground in the first place.”

The two are Robert Klein,
who led the ballot campaign that created the agency and became its
first chairman, and Irv Weissman of Stanford, who co-founded
StemCells, Inc., and sits on its board. Weissman, an internationally
known stem cell researcher, also was an important supporter of the
campaign, raising millions of dollars and appearing in TV ads. Klein,
who left the agency last year, appeared twice before the CIRM board
this summer to lobby his former colleagues on behalf of Weissman's
company. It was Klein's first appearance before the board on behalf
of a specific application.
The Times piece continued,

“But private enterprise
is new territory for CIRM, which has steered almost all its grants
thus far to nonprofit institutions. Those efforts haven't been
trouble-free: With some 90% of the agency's grants having gone to
institutions with representatives on its board, the agency has long
been vulnerable to charges of conflicts of interest. The last thing
it needed was to show a similar flaw in its dealings with private
companies too.”

Hiltzik wrote,

“(Weissman) has also
been a leading beneficiary of CIRM funding, listed as the principal
researcher on three grants worth a total of $24.5 million. The agency
also contributed $43.6 million toward the construction of his
institute's glittering $200-million research building on the Stanford
campus.”

CIRM board approval of the
$20 million for StemCells, Inc., came on 7-5 vote that also required
the firm to prove that it had a promised $20 million in matching
funds prior to distribution of state cash.
Hiltzik continued,

“The problem is that
StemCells doesn't have $20 million in spare funds. Its quarterly
report for the period ended June 30 listed about $10.4
million in liquid assets, and shows it's burning about $5 million per
quarter. Its prospects of raising significant cash from investors
are, shall we say, conjectural.

“As it happens, within
days of the board's vote, the
firm downplayed any pledge 'to raise a specific amount of
money in a particular period of time.' The idea that CIRM 'is
requiring us to raise $20 million in matching funds' is a
'misimpression,' it said. Indeed, it suggested that it might count
its existing spending on salaries and other 'infrastructure and
overhead' as part of the match. StemCells declined my request that it
expand on its statement. 

“CIRM spokesman Kevin
McCormack says the agency is currently scrutinizing StemCells'
finances 'to see what it is they have and whether it meets the
requirements and expectations of the board.' The goal is to set
'terms and conditions that provide maximum protection for taxpayer
dollars.' He says, 'If we can't agree on a plan, the award will
not be funded.'"

Hiltzik wrote,

“The agency shouldn't be
deciding on the spot what does or doesn't qualify as matching funds.
It should have clear guidelines in advance.

“Nor should the board
overturn the judgment of its scientific review panels without
clear-cut reasons....The record suggests that the handling of the
StemCells appeal was at best haphazard and at worst redolent of
cronyism.” 

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/6qvBfSLP3RE/los-angeles-times-stemcells-inc-award.html

Posted in Stem Cells, Stem Cell Therapy | Comments Off on Los Angeles Times: StemCells, Inc., Award 'Redolent of Cronyism'

California Stem Cell Agency Boosting Disease Team Program to $543 Million

Posted: October 21, 2012 at 7:57 am


Directors of the California stem cell
agency are set to give away $20 million next Thursday and authorize
a handsome addition to their signature disease team effort, bringing
its total to $543 million.

It is all part of the $3 billion
agency's push to develop therapies prior to running out of money for
new grants in 2017.
The $20 million is expected to go to
the first two winners in the agency's new strategic partnership
program. CIRM says the effort is aimed at
creating “incentives and processes that will: (i) enhance the
likelihood that CIRM funded projects will obtain funding for Phase
III clinical trials (e.g. follow-on financing), (ii) provide a source
of co-funding in the earlier stages of clinical development, and
(iii) enable CIRM funded projects to access expertise within
pharmaceutical and large biotechnology partners in the areas of
discovery, preclinical, regulatory, clinical trial design and
manufacturing process development.”
CIRM reviewed six applications with two winning approval. The agency's governing board is expected to ratify the decision next week. None of the applicants have been identified by the agency, which routinely withholds that information prior to
board action even when applicants have identified themselves.
Addition of a new $100 million
disease team round will come on top of the second, $213 million disease
team awards approved last this summer. The first round, awarded in
2009, totaled $230 million.  The size of the new round could be altered by CIRM directors prior to approval. Also before the board is a $40 million
proposal to expand the industry-friendly strategic partnership effort
into a second round.
The thrust of the disease team effort
is to speed the process of establishing clinical trials and to finance
efforts that might founder in what the biotech industry calls a
valley of death – a high risk financial location, so to speak,
where conventional financiers fear to tread.
The new disease team round will require
“co-funding” from applicants but the agency did not specify what
it means by the term. The matter of matching funds has become an issue in awards to StemCells, Inc., of Newark, Ca., in this summer's
disease team round.
Next week's agenda additionally
contains a plan to tighten review of proposed research budgets in
grant applications, making it clear that CIRM staff will be
negotiating such matters even after the board approves grants and
loans.
So far no researchers have testified in
public on the budget plan although it could well have a significant
impact on their future efforts.
Additional matters will discussed as
well at the meeting in Burlingame, which also has a teleconference
location in La Jolla that will be open to the public. The address
and additional material can be found on the agenda.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/1gFmBSDEYCU/california-stem-cell-agency-boosting.html

Posted in Stem Cells, Stem Cell Therapy | Comments Off on California Stem Cell Agency Boosting Disease Team Program to $543 Million

Researcher Alert: Stem Cell Agency to Take Up Grant Appeal Restrictions

Posted: October 21, 2012 at 7:57 am


The move by the $3 billion California
stem cell agency to curtail its free-wheeling grant appeal process
will undergo its first public hearing next week.

The proposals will mean that scientists
whose applications are rejected by reviewers will have fewer avenues
to pursue to overturn those decisions. The changes could take effect
as early as next year.
The move comes in the wake of a record
number of appeals this summer that left the board complaining about
“arm-twisting,” lobbying and “emotionally charged presentations.”
Among other things, the new "guidelines" attempt to define
criteria for re-review – “additional analysis” – of
applications involved in appeals, also called “extraordinary
petitions.” The plan states that re-review should occur only in
the case of a material dispute of fact or material new information.
(See the end of this item for agency's proposed definitions.)
In addition to alterations in the
appeal process, the CIRM directors' Application Review Task Force
will take up questions involving “ex parte communications.” The
agenda for the Oct. 24 meeting did not contain any additional
information on the issue but it likely deals with lobbying efforts on
grants outside of public meetings of the agency. We understand that
such efforts surfaced last summer involving the $$214 million disease
team round and Robert Klein, the former chairman of the stem cell
agency.
Klein appeared twice publicly before
the board on one, $20 million application by StemCells, Inc., the
first time a former governing board member has publicly lobbied his former
colleagues on an application. The application was rejected twice by reviewers – once
on the initial review and again later on a re-review – but it was
ultimately approved by directors in September on a 7-5 vote.
The board has long been troubled with
its appeal process but last summer's events brought the matter to a
new head. The issue is difficult to deal with because state law
allows anyone to address the CIRM governing board on any subject when
it meets. That includes applicants who can ask the board to approve
grants for any reason whatsoever, not withstanding CIRM rules. The board can also approve a grant
for virtually any reason although it has generally relied on
scientific scores from reviewers.
The proposals to restrict appeals are
designed to make it clear to scientists whose applications are
rejected by reviewers that the board is not going to look with favor
on those who depart from the normal appeals procedure.
While the board almost never has
overturned a positive decision by reviewers, in nearly every round it  approves some applications that have been rejected by reviewers. That has
occurred as the result of appeals and as the result of motions by
board members that did not result from public appeals.
Ten of the 29 board members are classified as patient advocates and often feel they must advance the cause of the
diseases that they have been involved with. Sometimes that means
seeking approval of applications with low scientific scores.
Here is how agency proposes to define
“material dispute of fact:”

“A material dispute of fact should
meet five criteria:(1) An applicant disputes the accuracy of a
statement in the review summary;(2) the disputed fact was significant
in the scoring or recommendation of the GWG(grant review group); (3) the dispute pertains
to an objectively verifiable fact, rather than a matter of scientific
judgment or opinion;(4) the discrepancy was not addressed through the
Supplemental Information Process and cannot be resolved at the
meeting at which the application is being considered; and
(5) resolution of the dispute could affect the outcome of the board’s
funding decision."

Here is how the agency proposes to
define “material new information:”

“New information should: (1)be
verifiable through external sources; (2) have arisen since the
Grants Working Group(grant review group) meeting at which the application
was considered; (3) respond directly to a specific criticism or
question identified in the Grants Working Group’s review; and (4)
be submitted as part of an extraordinary petition filed five business
days before the board meeting at which the application is
being considered."

Next week's hearing is scheduled for
Children's Hospital in Oakland with a teleconference location at UC
Irvine. Addresses can be found on the agenda.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/6sbxGqQJ77Y/researcher-alert-stem-cell-agency-to.html

Posted in Stem Cells, Stem Cell Therapy | Comments Off on Researcher Alert: Stem Cell Agency to Take Up Grant Appeal Restrictions

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