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Category Archives: Stem Cell Therapy

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

Posted: September 9, 2012 at 3:58 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 3:58 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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StemCells, Inc., Gunning for Another $10 Million from California Stem Cell Agency

Posted: September 9, 2012 at 3:57 pm


Fresh from winning $40 million from the
California stem cell agency, StemCells, Inc., is shooting for
another, $10 million award from the state research effort.

The latest proposal comes as the
publicly traded firm also faces the task of raising $40 million that it
has promised the agency to match the earlier awards. That figure
could well rise to $50 million given the new application.
Martin McGlynn, CEO of the
well-connected Newark, Ca., firm, disclosed StemCells, Inc.'s,
latest proposal in an article by Catherine Shaffer in BioWorld. She
wrote,

“Already looking ahead, StemCells has
set its sights on one more CIRM initiative designed to fund early
stage clinical trials over a four-year period. StemCells has applied
for that grant, worth up to $10 million, to fund a Phase II trial in
PMD(Pelizaeus-Merzbacher disease).”

The article did not disclose the timing on the new application.
StemCells, Inc.'s lobbying efforts with the stem cell agency were vigorously aided by the former chairman of the $3 billion
California stem cell agency, Robert Klein (see here and here). And Wednesday evening, the company convinced
the state agency's board to overturn two successive reviewer rejections of a
$20 million proposal for Alzheimer's research. The vote was 7-5.
Klein's efforts came in a record-breaking round of appeals and emotional presentations by patient advocates, which triggered complaints from the board this week about "arm-twisting" and politicking. 
StemCells, Inc., was founded by the
eminent Stanford stem cell researcher Irv Weissman, who helped to
raise millions for the ballot initiative that created the stem cell
agency. He additionally appeared in in the campaign's TV advertising.
The campaign was headed by Klein, who ultimately raised $35 million
to convince voters to create the agency. Weissman is currently on the board
of the StemCells, Inc. His wife is executive vice president.
In July, the stem cell agency board
approved the first $20 million award to the firm for research involving spinal injury.
McGlynn told BioWorld,

"We're the only company that has
programs going on in all three regions of the central nervous system:
the brain, the spinal cord and the eye."

Not discussed in the BioWorld article
was a requirement, imposed by the CIRM board, that StemCells, Inc.,
show it can deliver $20 million in matching funds on the Alzheimer's
award before receiving any state funds. CIRM said no such board
requirement existed on the spinal award, but the firm has promised to
match the $20 million on that award as well.
BioWorld described the awards as
grants. In fact, they are loans. But under the terms of the loans, if
the research is not successfully commercialized, it will be
forgiven.  

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Arm-twisting and Emotion: Stem Cell Directors Move to Reform Appeals on Multimillon Dollar Grants

Posted: September 9, 2012 at 3:57 pm


Frustrated with politicking,
“arm-twisting,” lobbying and “emotionally charged
presentations,” the governing board of the $3 billion California
stem cell agency today approved short-term changes in its grant
appeal process and ordered up a study to prepare long-term reforms.

The moves followed a prolonged series of appeals on grant applications that began in July and continued through today,
setting records for the number of appeals and generating hours of
sometimes tearful and emotion-laden presentations from members of the
public.
The board adopted changes in the appeal process for its next few meetings that are aimed at curbing its
free-wheeling nature and making it more understandable to the public
and applicants. The board also directed creation of a panel to make
recommendations by the end of the year for more wide-ranging reforms.
Directors of the agency were clearly
not happy with the appeal process this summer. However, it has been a
problem since 2008 when Bert Lubin, now a director of the stem cell
agency and CEO of Childrens Hospital of Oakland, Ca., was the first applicant to make a public pitch before the board to overturn
reviewer rejection of his application.
One director, UCLA medical school dean,
Gerald Levey, said at the time,

"I don't think we can run a board
this way. If we do, it would be chaos." 

Today, CIRM Director Carmen Puliafito,
dean of the USC School of Medicine, said that “lots of lobbying”
was going over the last couple of months. He predicted there will
more lobbying and “more politicking.” Puliafito said,

“On big money grants, people will be
calling their friends.”

The name of former board chairman,
Robert Klein, was not mentioned during this afternoon's discussion.
But Klein vigorously and successfully backed an appeal (see here,
here and here) by StemCells, Inc., of Newark, Ca., for a $20 million
application that had been rejected twice by reviewers. Last night the
board approved the award on a 7-5 vote. It was the first time the
board has approved an award that was rejected twice by its reviewers.
Director Jeff Sheehy, co-vice chairman
of the review group and a communications manager at UC San Francisco,
said the agency is dealing with “big money grants” that are
“incredibly complex.” He also referred to “certain arm-twisting
by certain individuals.”
Several board members made references
to appearances by persons who have diseases or conditions that might
be affected by CIRM-financed research. Director Duane Roth, head of
CONNECT, a San Diego business development organization, said the
board is making decisions in “an emotionally charged setting.”
Other issues cited by directors include
the integrity of review process, fairness, consistency, shifting
appeals procedures, transparency and board discipline on appeals.

James Harrison, outside counsel to the board, said the board's action today includes "eliminating the reference to unpublished data in the discussion of 'material new information," imposing a 3-page limit on other correspondence, explaining that applicants should have seven business days from the time the (grants review group) recommendation is made available to them to file an (extraordinary petition), and posting all of the information regarding these policies in one place on CIRM’s website."

For a list of articles and CIRM
documents dealing with the appeal process, see here.

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California Stem Cell Agency Okays $38 Million for Basic Research

Posted: September 9, 2012 at 3:57 pm


Directors of the California stem cell agency today approved about $38 million for research into basic biology, including two appeals by researchers on applications initially rejected by reviewers.

The governing board turned down five appeals in the round, which attracted 357 applications in its "pre-app" process, 64 of which were invited to apply. Reviewers approved 25 applications.

The following appeals in the biology round were approved:

  • $1.3 million, Deborah Lieu of UC Davis. (Review summary here, appeal here.) 764
  • $1.4 million, Yanhong Shi  of the City of Hope. (See review summary here and appeal here.)

The board also approved another application that was rejected by reviewers based on a recommendation by CIRM President Alan Trounson.  It is very unusual for the board to approve rejected applications based on staff recommendations following a review. Trounson described the grant addressed a major bottleneck in stem cell science.

 The California stem cell agency is expected to post a press release shortly with the names of all recipients. The agency usually withholds names of applicants until the the board formally acts.
(An earlier version of this item reported that the board approved $37 million in grants.)

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Florida Researcher Wins $6.7 Million Grant to Come to Golden State

Posted: September 9, 2012 at 3:57 pm


Dennis Steindler
UF Photo

The governing board of the California stem cell agency this morning approved a $6.7 million grant to recruit Dennis Steindler of the University of Florida to the Parkinson's Institute in Sunnyvale, Ca.

The grant was approved immediately following a 45-minute executive session with no further debate. (For more on this, see here, here and here.)

Steindler later told the California Stem Cell Report he would begin work in California as soon as possible.

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Board Concludes Private Session on Recruitment Grant

Posted: September 9, 2012 at 3:57 pm


The governing board of the California stem cell agency has just concluded a 45 minute executive session on a $6.7 million grant to recruit a Florida scientist to the Parkinson's Institute in Sunnyvale, Ca.

It was the longest executive session ever on a recruitment grant, which are usually approved routinely with little serious discussion.

The board is now resuming discussion of the matter(see here and here.)

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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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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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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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