StemCell Therapy

Looking for a good job at an
enterprise that is on the cutting edge of biotechnology?

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

During the last few months, the $3 billion California stem cell
agency, which is approaching its eight-year anniversary, has chalked up a
number of important firsts.

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

StemCells, Inc., said yesterday that it
will come up with the $40 million needed to match loans from the California
stem cell agency through “existing infrastructure and overhead”
and will not be issuing stocks or warrants to the agency.

“We have incurred significant
operating losses since inception. We expect to incur additional
operating losses over the foreseeable future. We have very limited
liquidity and capital resources and must obtain significant
additional capital and other resources in order to provide funding
for our product development efforts....”

Martin McGlynn StemCells, Inc., Photo

“To be clear, we do not interpret the
diligence requirement as an obligation to raise a specific amount of
money in a particular period of time, and we wish to correct the
misstatements made by some uninformed third parties that the ICOC is
requiring us to raise $20 million in matching funds. In
point of fact, we expect that a substantial amount of our
contribution towards these projects will come from existing
infrastructure and overhead, salaries for our existing personnel, and
other contributions in kind. Furthermore, we will soon be
reviewing the budgets for both projects in detail with CIRM
staff. Because each disease team budget was prepared on a
stand-alone basis, we expect to see significant economies and
efficiencies now that the company has in fact been awarded funding
for both.”

"Under this particular CIRM
program (RFA 10-05), funding for companies will be in the form of
unsecured, non-recourse, interest-bearing, term loans, which will be
forgivable in the event the funded research fails to result in a
commercialized product. On the other hand, should the product be
successfully commercialized, CIRM would earn milestone payments
depending on how successful the product becomes. Because CIRM
shares the downside risk, and could participate handsomely on the
upside, the structure makes the loan about as close to 'equity' as one could, without having to dilute existing shareholders in order
to gain access to significant amounts of capital.  The company
will not issue stock, warrants or other equity to CIRM in connection
with these awards. 

"Of course, we realize that CIRM
prefers that applicants from industry provide evidence of their
ability to secure whatever additional funds may be needed to complete
any CIRM-funded project, in this case the filing of an IND for each
indication. This is stated in the text of RFA 10-05 itself and
was repeated in various comments by CIRM staff during the application
process. When making the second award on September 5, the
ICOC naturally recognized the sizeable commitment it was making
to StemCells, so it instructed CIRM staff to satisfy themselves
of the company's ability to access the capital needed to fund the
project, namely the Alzheimer's program through to the filing of the
IND.”

"Finally, I can confirm that in
June of this year the Company applied for up to $10
million under CIRM's Strategic Partnership I program
(RFA 12-05). Unlike the disease team awards under RFA
10-05, if companies are approved for funding under RFA 12-05, they
may elect to take such funding in the form of a grant, not a
loan. Our application under RFA 12-05 is for a controlled Phase
II clinical trial of HuCNS-SC cells in Pelizaeus-Merzbacher disease
(PMD), a rare myelination disorder. StemCells completed a Phase
I study in PMD in February 2012 and in April announced that
all of the patients from that study showed evidence of cell-derived
myelination and three of the four patients in the study showed
measurable gains in motor and/or cognitive function.”

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

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.

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

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

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

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.

“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).”

"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."

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

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.)

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

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.

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

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.)

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

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.

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

"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."

"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.'"

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

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.

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

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

 "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." 

 "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.

"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."

 “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.”

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

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 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....”

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.

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

The chairs are shifting a tad on the
governing board of the $3 billion California stem cell agency as a
French immigrant is added, a Latino leaves and a veteran patient
advocate is reappointed.

Anne-Marie Duliege Affymax Photo

State Controller John Chiang appointed
Duliege to the CIRM post, saying, 

“Dr. Duliege brings
first-hand knowledge of what is required to take a drug from research
phase through FDA approval.”

David Serrano Sewell CIRM Photo

Serrano Sewell, who has also served on
the CIRM board since its inception, is apparently resigning to accept
an appointment to the board that regulates
California physicians. Apparently – because the stem cell agency
has not confirmed that he is leaving, although this morning it placed a resolution honoring him on the agenda for next week's meeting.  That almost invariably means a board member is departing.

Jeff Sheehy CIRM Photo

Sheehy was reappointed recently by
state Senate President Pro Tem Darrell Steinberg. Sheehy is a
communications manager at UC San Francisco and a nationally known
HIV/AIDS advocate. He is co-chairman of CIRM's Science Subcommittee
and vice chairman of the grants review group. Sheehy leads the
discussion of grant applications when they come before the full board
in public session.

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

A robust discussion has arisen
concerning Bob Klein and his appearance last month before the
governing board of the $3 billion California stem cell agency, a body
that he once chaired and an enterprise that he once oversaw.

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

Four researchers are appealing
rejection of their proposals to win millions of dollars from the
California stem cell agency just as the agency is moving to curb such
reconsideration efforts by scientists.

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

The $3 billion California stem cell
agency on Tuesday released details of proposed, major changes in how
scientists are allowed to appeal decisions when their
applications for millions of dollars are rejected by grant reviewers.

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

“So a project that was really going
to go into patients was essentially triaged.”

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

Researchers from the University of
Southern California are making a pitch to overturn rejection of their
$20 million grant application by reviewers in one of the signature
commercialization rounds of the California stem cell agency.

“We are submitting the petition at
this time as we are new to the CIRM ICOC(governing board) process and after listening
to the July 26 ICOC meeting deliberations now understand that the
petition process allows the ICOC to further consider our proposal.
We noted that the proposal scored one point above ours and another
two points below ours, each utilized the extraordinary petition
strategy to gain ICOC review which resulted in funding approval in
the former, and reconsideration in the latter instance.”

“I'm not really quire sure that all
of the applicants clearly understood that they could come back to us
to address the criticisms(of reviewers).”

Concerns about whether all applicants fully understand the appeal process have surfaced on a number of occasions over the last several years. The CIRM board, however, is generally reluctant to overturn negative recommendations by reviewers. It also almost never reverses positive recommendations.

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

Directors of the California stem cell
agency next week are expected to make unspecified changes in how
scientists can appeal denials of their applications for millions of
dollars in research grants.

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

“I wanted to comment on this piece
from the perspective of another patient advocate.  While I think
you know that I did not always agree with Bob Klein during his tenure
on the ICOC(the agency's governing board), I would strongly defend
his right to appear and give his opinions to the Board.  He is a
private citizen now, albeit one with considerable experience and
expertise, and I think his greatest vested interest in this case
stems (you should pardon the expression) from being the child of a
parent with Alzheimers.  As you point out, some eyebrows may be
raised, and I can imagine that some board members might be swayed in
either direction by his testimony, but  he is a passionate and
committed advocate, and he has the right to advocate before us.”

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