California Stem Cell Agency Okays $38 Million for Basic Research

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.)

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

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.

Board Concludes Private Session on Recruitment Grant

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.)

Dennis Steindler Application: Excerpt from Review Summary

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.'"

CIRM Board Eyes Florida Researcher for $6.7 Million Grant

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.

Two Additional Appeals Rejected in Disease Team Round

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.

Operator Error by Blog ! CIRM Audiocast Up

The audiocast for the meeting this morning of the governing board of the California stem cell agency is now up. Be sure to use the correct code to sign in(there are two different ones). This writer did not and initially received yesterday's audiocast.

The board is currently discussing the "bolt-on" changes re grants.

CIRM Governing Board Meeting: Audiocast Problems

Today's meeting of the governing board of the $3 billion California stem cell agency should be getting underway shortly. For those of you interested in the live Internet audiocast, the voice you are now hearing on that service is that of CIRM President Alan Trounson. The audiocast is a repeat from the beginning of yesterday's session. We have queried the agency about the status of the audiocast, which is performed by ATT.

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

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.  

CIRM Board Adjourns

The governing board of the California stem cell agency adjourned at 9:56 p.m. PDT today and will reconvene tomorrow morning at 9 a.m. PDT. The California Stem Cell Report will provide coverage of the daylong meeting then. No further items are expected this evening.

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

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.

CIRM Executive Session on StemCells, Inc., Appeal

The governing board of the California stem cell agency is meeting in executive session to consider proprietary information on an appeal by StemCells, Inc., following a second public pitch by the agency's former chairman, Robert Klein, on behalf of the financially strapped business.

Martin McGlynn, CEO of the publicly traded firm, indicated to the board that it may have to drop its Alzheimer's research program if it does not receive the $20 million from CIRM.

 The board's executive session followed rejection of another Alzheimer's related application, this one from researchers at USC.

USC Loses Appeal on $20 Million Proposal

Directors of the California stem cell agency this evening rejected an application for a $20 million research grant to a team at the University of the Southern California. 

The team, led by Roberta Diaz Brinton, filed an appeal last month in the $200 million disease team round, which first came up for consideration in July. CIRM staff pointed out that normally such appeals are considered at the time the round is first considered by the board.

The vote was split on the application, but actual tally was not announced by the agency following the vote. (Later, at the request of the California Stem Cell Report, a board spokesman said the vote was 4-10 on the 29-member board.)

Brinton and other investigators spoke to the board along with several patient advocates.

(An earlier version of this item did not contain the 4-10 vote.)

UCLA's Nelson and Miceli Win $6 Million from California Stem Cell Agency

Directors of the California stem cell agency today approved a $6 million research grant for Stanley F. Nelson and M. Carrie Miceli  of UCLA, who appealed a negative decision  by grant reviewers on its earlier $20 million request.

Following a re-review of the proposal, a special CIRM panel recommended the lower amount and conversion of the proposal to an early translational grant instead of a disease team. The UCLA team will be asked to send a revised proposal to CIRM prior to funding.

Nelson told the board that he was "okay" with the revision and said his team would be back later for more funding for a larger project.

UC Irvine's Klassen Wins $17.3 Million from California Stem Cell Agency

Directors of the California stem cell agency this evening approved a $17.3 million grant to Henry Klassen of UC Irvine following a re-review of the application in the agency's disease team round. The action came with no debate.

Capricor Wins $20 Million from California Stem Cell Agency

Directors of the California stem cell agency this evening approved an award of up to $20 million to Capricor, Inc., of Los Angeles, rejecting a negative decision on the application by agency reviewers.

Approval of the application came after a re-review triggered by Capricor's appeal in July. The governing board also declined to impose a staff-recommended condition dealing with the patient cohort.

Discussion of Disease Team Appeals Begins

The CIRM board is beginning the discussion of the appeals on disease team appeals. Thomas is reviewing the procedure for re-reviews of the applications.

Busy Agenda Tonight for CIRM Directors

CIRM Chairman J.T. Thomas just announced that he is going to try act tonight on most of the items on the agenda. Exceptions will be the basic biology grant, recruitment grant and resolutions, which will be taken up tomorrow. Discussion is now underway on the grants administration policy changes.

Routine Reports Being Heard at CIRM Directors Meeting

CIRM directors are now hearing routine financial and other reports from CIRM staff, including President Alan Trounson. The grant appeals have not yet been taken up.

CIRM Directors Meeting Begins

Directors of the $3 billion California stem cell agency have begun their meeting. However, the audiocast was down until just 20 minutes after the hour.