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Category Archives: Stem Cell Therapy

Two More Disease Team Applications Sent Back for More Review


Directors of the California stem cell agency today referred two additional research applications for $37 million in disease team funding back to reviewers for further consideration.

Both were the subjects of appeals by researchers whose proposals were rejected by grant reviewers.

One was from Timothy Hoey of OncoMed Pharmaceuticals in Redwood City, who sought $20 million.  The other was from Henry Klassen of UC Irvine, who sought $17 million. (See here and here for their appeals.)

The  board began the day by directing staff to come back to the board in early September. But with the large number of grants to be reassessed, it was acknowledged some might not be acted on until the board's meeting in late October.

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Harvard’s McMahon on His Way to USC


Andy McMahon
Harvard photo

The governing board of the California stem cell agency this afternoon approved a $5.7 million grant to lure a Harvard researcher to the University of Southern California in Los Angeles.

The scientist is Andrew McMahon, who serves on the executive committee of the Harvard Stem Cell Institute. CIRM officials said McMahon is ready to begin his work immediately at USC.

McMahon won stellar reviews from CIRM's grant reviewers who said he was an “exceptional scientist and one of the leading young developmental biologists.” Reviewers gave his proposal a score of 90 and, in summary, said,

“Major strengths include the candidate's exceptional productivity and contributions to the fields of mammalian embryology and kidney development, the significance and potential of the research program, the PI's proven leadership capabilities, and the outstanding institutional commitment.”

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Stem Cell Directors Approve $151 Million to Commercialize Stem Cell Research


Directors of the California stem cell
agency today approved $151 million in research awards aimed at
commercializing stem cell research and pushing therapies into
clinical treatment.



Patients and researchers cheered when the action was announced. 


The awards of up to $20 million each
were ratified by CIRM's governing board, which added two to the
six applications approved by reviewers. The 
original
six
 totalled $113 million. Directors budgeted $243 million
for today's round.



Five of the applications involving
appeals were sent back by the board for more review.
(See 
here, here and here.)
They will be considered again in early September or October.

The awards are the
second largest research round
 in CIRM's history,
surpassed only by an another, earlier $211 million “disease team”
round. The latest effort is aimed at bringing
proposed clinical trials to the FDA for approval or possibly starting
trials within four years.
 That deadline coincides roughly
with the date when CIRM is scheduled to run out of cash unless new
funding sources are developed.
CIRM is currently exploring seeking
private financing. It could also ask voters to approve another state
bond issue. (Bonds currently provide the only real source of cash for
CIRM.)  In either case, the agency needs strong, positive
results from its grantees to support a bid for continued funding.
Today's action came after nine out of
the 15  applicants who were rejected by reviewers appealed the
 negative decisions. Two of the appeals were successful at today's meeting. It is a
good bet that at least some of those referred for more review
will be ratified by the board in September. 
The appeals were based on a variety of
issues, ranging from technical science questions to inconsistencies
in CIRM's research approaches and mistakes by reviewers.
The outpouring
of appeals
 was the largest in CIRM history in terms of the
percentage of applicants seeking to overturn reviewer decisions.
The round also marked
another first
 in terms of the total initially approved by
reviewers. On occasion in the past, reviewers have not approved
enough awards to consume all the funds budgeted by the CIRM board.
But never before has the amount fallen so far short.
Most of the awards went to enterprises
connected to persons on 29-member CIRM governing board, continuing a
trend that has existed throughout CIRM's history. Board members with
conflicts, however, are not allowed to vote or participate in the
The full list of the winners and the
CIRM press release can be found here.

(Editor's note: This item was updated from an earlier version and the figures increased as the CIRM board added another grant and took additional action.)

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StemCells, Inc., and Capricor Stave Off Rejection from Stem Cell Agency


Two California stem cell firms today
won a reprieve from rejection in their bids for $40 million in
funding from the California stem cell agency.

They are StemCells, Inc., of Newark
and Capricor, Inc. of Beverly Hills. StemCells was founded by
Stanford researcher Irv Weissman. Capricor was formed to
commercialize research at Cedars of Sinai that had been previously
financed in part by the state's $3 billion enterprise. Frank
Litvack
, who unsuccessfully vied for the chairmanship of the stem
cell agency in June 2011, is the recently appointed executive
chairman of Capricor.
The CIRM board sent the firms' bids back for more scientific review based on
their appeals of reviewers' negative decisions as well as testimony
at the board meeting today. The board will take up the applications, which seek $20 million each, again in early September.

Robert Klein, who was the first
chairman of the stem cell agency, appeared before his old board as a
member of the public on behalf of the StemCells appeal. He said new
evidence will be published soon in a scientific journal that supports
the StemCells approach. Klein also said that he was personally
involved in three CIRM grant reviews in which scientists affirmed the
company's approach. (Here are links to the appeal and to grant reviewer comments.)
The other application also involved new
information. Litvack, former CEO of Conor Medsystem, told the board
the firm has made considerable progress since CIRM's closed-door
review of applications last April, both in terms of management and
science. The firm's appeal said Litvack's appointment is part of the
management improvements at the firm.
Sherry Lansing, a member of the CIRM
board and former CEO of a Hollywood film studio, enthusiastically
recalled a presentation last year before the board about the results
of the initial research. She the firm has solved the problems cited by reviewers. She said,

“We have a fiduciary responsibility
to select the best science.”

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$18 Million Cedars Sinai ALS Proposal Headed for Approval


The California stem cell agency today
cleared the way for approval of
an $18 million grant to develop a new
cell-based therapy for treatment of ALS.

The agency's governing board moved the
application into a category that is expected to approved later today.
The action came on an appeal by
researcher Clive Svendsen of Cedars Sinai. Also supporting the
application were a number of persons with ALS.

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Rejected Grants May Be Sent Back for More Review


California stem cell agency chairman J.T. Thomas has raised the possibility of sending some of the disease team applications back for additional review if the board feels that is necessary to consider new information and resolve scientific disputes. 

Thomas discussed such a move at the beginning of the discussion of the $243 million disease team round. Nine out of 15 rejected applicants have appealed to the full board.  Some have presented new information. Others have disputed the scientific work of reviewers. 
The board used such a referral process for one application in the past. That grant was ultimately approved.

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