Wednesday, July 18, 2012

UC Davis Researchers Score Big in $113 Million Stem Cell Award Round

Scientists at the University of California at Davis are set to win nearly half of $113 million expected to be awarded next week by the California stem cell agency as it pushes aggressively to turn research into marketplace cures.

Directors of the $3 billion agency are virtually certain to approve awards to three researchers at UC Davis, which operates its medical school and other research facilities in nearby Sacramento. The other three expected winners are from UCLA, Stanford and StemCells, Inc., of Newark, Ca., a publicly traded firm.

The $113 million round is 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 is close to the time 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.

The CIRM board is scheduled to approve the latest awards one week from tomorrow at a public meeting in Burlingame in the San Francisco area. The agency's policy is to withhold the identities of applicants and winners until after formal board action. The California Stem Cell Report, however, has pieced together their identities from public records.

Here are the winners and links to the grant review summaries, listed in order of the CIRM scientific scores:
  • Vicki Wheelock, UC Davis, $19 million, for development of a genetically modified cell therapy for Huntington's disease, an inherited neurodegenerative disorder. Scientific score 87.
  • Antoni Ribas, UCLA, $20 million, for genetic reprogramming of cells to fight cancer. Scientific score 84.
  • Nancy Lane, UC Davis, $20 million, for development of a small molecule to promote bone growth for the treatment of osteoporosis. Scientific score 80.
  • John Laird, UC Davis, $14.2 million, for development of mesenchymal stem cells genetically modified for treatment of critical limb ischemia, which restricts blood flow in the lower leg and can lead to amputation. Scientific score 79.
  • StemCells, Inc., (principal investigator not yet known), $20 million, for development of human neural stem cells to treat chronic cervical spinal cord injury. The company, founded by Stanford scientist Irv Weissman, who serves on its board, said earlier this year that it had filed two applications in this round, one of which dealt with cervical cord spinal injury. No other applicants filed a proposal for such research. Scientific score 79.
  • Robert Robbins, Stanford, $20 million, development of a human embryonic stem cell treatment for end-stage heart failure. Scientific score 68.
In the case of businesses, the awards come in the form of loans. Grants go to nonprofits. One of the reasons behind the varying mechanisms is the difference in CIRM's intellectual property rules for businesses and nonprofits.

CIRM's Grant Working Group earlier this year approved the applications during closed door sessions. The full CIRM board has ultimate authority on the applications, but it has almost never rejected a positive action by the grant reviewers.

The board originally allotted $243 million for this round. Directors could reach into the 15 applications rejected by reviewers and approve any of them, which the board has done in other rounds. In this round, three rejected applications scored within seven points of the lowest rated application approved by reviewers, which could lead some directors to argue that the scores are not significantly different. One of the three came from Alexandra Capela of StemCells, Inc., and was scored at 61. The other two and their scores are Clive Svendsen of Cedars-Sinai, score 64, for ALS research, and Roberta Brinton of USC, score 63, for an Alzheimer's project.

Rejected applicants also can appeal reviewer decisions to the full CIRM board in writing and in public appearances before directors.

Twenty-three researchers were eligible to apply for funding, CIRM told the California Stem Cell Report. Applicants qualified by either winning a related planning grant from CIRM last year or by being granted an exception to that requirement by CIRM staff. Of the 22 researchers who ultimately applied(one nonprofit dropped out), six came from biotech businesses. Three of those qualified through exceptions. Three other businesses won planning grants last year out of the eight businesses that applied.

CIRM has come under fire for its negligible funding of stem cell firms and is moving to embrace industry more warmly.

Only one of the grants approved by reviewers involves research with human embryonic stem cells, which was the critical key to creation of the California stem cell agency. California voters established the agency in 2004 on the basis that it was needed because the Bush Administration had restricted federal funding of human embryonic stem cell research.  
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