Showing posts with label ankasa. Show all posts
Showing posts with label ankasa. Show all posts

Thursday, March 21, 2019

Down to its Last $67 Million: California Stem Cell Agency Awards $4 Million to Improve Bone Healing


A look at the the spinal affliction targeted by CIRM-backed research. Video by NuVasiveInc

OAKLAND, Ca. -- California's state stem cell agency is down to its last $67.3 million following a decision today to back research to enhance bone healing in elderly patients who undergo spinal surgery.

The $4 million award went to Ankasa Regenerative  Therapeutics following little discussion among members of the governing board of the $3 billion California Institute for Regenerative Medicine or CIRM, as the stem cell agency is known. 

Ankasa, which has locations in La Jolla and South San Francisco, is supporting the award with a matching amount of $1 million. Sandy Madigan, CEO of Ankasa, told the California Stem Cell Report that his firm has raised $19 million in venture capital. Its only current potential product, he said, is tied to the CIRM-backed research, which the agency has previously funded with $8.6 million. 

(See here and here for more on the Ankasa work.)

CIRM said at today's meeting that the award leaves the agency with $67.3 million for research for the remainder of the year. It has budgeted a total of $93 million for clinical stage awards this year.

The stem cell agency was created in 2004 with $3 billion in funding. It expects to run out of cash for new awards later this year. CIRM is seeking to raise $220 million privately to tide it over until November 2020, when it hopes voters will approve another $5 billion in funding through the use of state bonds. 

CIRM board Chairman Jonathan Thomas did not report at the meeting today on the status of the private fundraising effort. 

The only significant source of cash for the agency is the $3 billion in bonds approved by voters in 2004 via the ballot initiative process. The 2020 effort would also involve a ballot initiative. 

The deadline for filing such a measure is Aug. 19. That would set the stage for actually gathering the 585,407 valid  signatures needed to qualify for placement on the ballot. 

Today's award was approved Feb. 28 behind closed doors by the agency's out-of-state reviewers, who sent it to the CIRM board for routine ratification. 

The six-page, CIRM summary of the review said the proposal (CLIN1-11256) addresses "the need for a spinal fusion material that can increase the chance for a solid bony union in the lumbar spine." The review said, "There are other products on the market that fulfill this need but have safety concerns that have been raised in the past."

Jill Helms, chief scientific officer of Ankasa and a professor at Stanford University, led the research backed by CIRM. 

The review summary said the proposed treatment could have application in other areas as well. It is likely to be some years before the procedure would be widely available. Today's award supports efforts by Ankasa to gain federal approval to begin clinical trials.

See here for the CIRM press release on the award. 

Monday, December 05, 2016

California Approves $15 Million for Stem Cell Research Ranging from Arthritis to Alzheimer's, But Not Without a "Hair-Cut"

Highlights
Snafu in November
Ankasa whacked
Across-the-board cuts rejected

After a hiccup last month, the California stem cell agency today coughed up $15 million for a quartet of researchers looking into Alzheimer's disease, cartilage repair, arthritis and sickle cell disease, but not before lopping off a big chunk of one proposal.

Action by the governing board of the $3 billion agency came after a snafu at its Nov. 17 meeting. The proposals, all previously approved by the agency's reviewers, hit a roadblock when the budgeted cash was not enough to fund all four. The session last month also stalled as a result of quorum problems and research priorities.

Normally applications approved by reviewers during their closed-door sessions slip through the later public meetings of the agency board with no discussion. But this time around, reviewers approved the four applications, but gave one of the researchers a sizable, financial "hair cut."

Despite concerns about fairness and imposing new conditions on applicants, the board stripped $1.6 million from a $3.7 million application to develop a stem cell therapy for osteoarthritis by Ankasa Regenerative Therapeutics of La Jolla.

The action came after the lead researcher, Jill Helms of Stanford, said her company would make up the shortfall.  She made the comment after being told she could re-submit the application, which was the last to come up for a vote. She indicated that she would prefer to pursue that route rather attempting a problematic and "onerous" re-application with a new set of reviewers early next year.

The other three applications were approved with full funding after a motion to cut all four by about 10 percent failed on a 1-9 vote with one board member abstaining. Board members used the term "hair cut" to describe the reductions, which the applicants would have to make up.

Helms' application was the only one in this round from a business. The others came from non-profit institutions.

Randy Mills, president of the California Institute of Regenerative Medicine or CIRM as the stem cell agency is formally known, opposed the 10 percent cuts on all four awards. He said he and his staff did not want to see programs cut "on the fly." He said applicants were not told that they would have to come up with matching funds when they originally applied.

The other three researchers winning awards are Yadong Huang of the Gladstone Institutes, $6 million for Alzheimer's;  Mark Walters of Children's Hospital, Oakland, $4.5 million for sickle cell, and Denis Evseenko of USC, $2.5 million for cartilage repair.

All the awards went to researchers or institutions that have links to persons who sit on the 29-member board. Overall, about 90 percent of the money awarded by CIRM since 2004 has gone to institutions with ties to past or present board members. While board members set rules for funding and the scope of awards, they are not allowed, however, to vote on specific applications from institutions with which they are connected.  

Summaries of reviewers comments, scores and more can be found on this document from CIRM, which is based in Oakland.  Here is a link to the CIRM press release.

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