Thursday, June 15, 2017

Guest Posting: "Stem Cell Options Should be on the Table"

(Editor's note: The following is a guest posting from Joseph Rodota and Bernard Munos, both of whom have been active in California policy matters for some time. More biographical information can be found at the end of the item. The California Stem Cell Report welcomes diverse, well-considered views on California stem cell issues. If you have something that you think should see the light of day, please send it to djensen@californiastemcellreport.com.)

By Joseph Rodota and Bernard Munos

The sponsors of Proposition 71, the 2004 initiative that provided $3 billion in bonds to support stem-cell research, are readying a proposal to keep the agency alive after the last of these funds have been given out. According to recent news reports, a new $5 billion bond could be on the California ballot as early as November 2018.

Researchers supported by the California Institute for Regenerative Medicine (CIRM) have published hundreds of academic articles, but placed fewer than 30 drugs in clinical trials.

Even if all of these clinical trials resulted in drug candidates, they would still come up against the so-called “Valley of Death”—the well-documented shortage of funding for early-stage translational research.

California needs to move regenerative medicine from an academic timeline to a business timeline. The skills needed to turn an academic discovery into a commercial product are very different from the skills needed to be a successful academic scientist.

We proposed an alternative to continuing the current approach -- a state bond with three distinctive features:

A Focus on Entrepreneurs: Funds would be available only to companies, not academics (who would still be able to tap into billions in NIH funding for stem cell research);

A Focus on California: Only companies with a headquarters and a majority of employees in California, the nation’s center of overall innovation, or willing to relocate here; and

A Focus on Breakthrough Medicine: Only companies working on projects that have the potential to greatly impact patient health would qualify.

The University of California is well-qualified to administer this bond and report on its operations to the Legislature and the Governor, without the need for the cumbersome and controversial governance structure put in place by Proposition 71.

In exchange for the funds they receive, companies would tender to the University of California shares of their common stock, with an estimated value as determined by the most recent outside valuation or price set by investors. These shares would become part of the UC endowment -- and the University of California be free to sell or leverage these shares, or acquire additional shares, as it sees fit.

CIRM has over-invested in academic research, and under-invested in translating that research into therapies that cure diseases and prolong heathy lives. California needs to right that balance.

(Joe Rodota served as Cabinet Secretary to former California Governor Pete Wilson and director of policy for Arnold Schwarzenegger’s 2003 recall campaign. Munos is a senior fellow with FasterCures and the founder of the Innothink Center for Research in Biomedical Innovation.).

Here is a summary of the bond proposal.

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Tuesday, June 13, 2017

California Stem Cell Agency Reports 'Streak of Good News' on Asterias Spinal Therapy

Asterias video
California's $3 billion stem cell program today reported ongoing rosy results in a clinical trial involving a therapy for severe spinal cord injury.

The treatment is being developed Asterias Biotherapeutics, Inc., of Fremont, Ca., with $14.3 million from the state research program, which is now in its 12th year.

The latest news was reported on The Stem Cellar, the agency's blog, and was based on a news release from Asterias, which is publicly traded. 

Todd Dubnicoff, the agency's multimedia editor, wrote the item which discussed nine-month results for the trial involving six patients paralyzed from the neck down. He said,
"In a nut shell, their improvements in arm, hand and finger movement seen at the earlier time points have persisted and even gotten better at 9 months."
Dubnicoff said that the level of improvement "can mean the difference between needing 24-hour a day home care versus dressing, feeding and bathing themselves."

He said,
"The impact of this level of improvement cannot be overstated. As mentioned in the press release, regaining these abilities, 'can result in lower healthcare costs, significant improvements in quality of life, increased ability to engage in activities of daily living, and increased independence.'"
In the Asterias press release, Edward Wirth, chief medical officer for the company, said,
“The new efficacy results show that previously reported meaningful improvements in arm, hand and finger function in the 10 million cell cohort treated with AST-OPC1 cells have been maintained and in some patients have been further enhanced even 9 months following dosing. We are increasingly encouraged by these continued positive results, which are remarkable compared with spontaneous recovery rates observed in a closely matched untreated patient population.”
The company also reported that no "serious adverse events" have surfaced that could be attributed to the therapy, which was initially developed  by Geron, Inc., which received $6.4 million from the stem cell agency. Geron abandoned the trial for financial reasons, and Asterias acquired the technology.

Aserias' stock price jumped nearly 13 percent today, hitting $3.55. Its 52 week high is $5.80 and its 52-week low is $2.30. Sphere: Related Content