Thursday, May 22, 2014

California Stem Cell Agency Expected to Pump $14 Million into Revival of hESC Clinical Trial Dropped by Geron

Geron's abandoned clinical trial for a spinal cord therapy based on human embryonic stem cells appears to be back on again but at a different company and with $14.3 million in help from the California stem cell agency.

An eagle-eyed anonymous reader of the California Stem Cell Report pointed out the upcoming award to Asterias Biotherapeutics/Biotime, which purchased the stem cell operations of Geron Corp. Geron ditched the trial in November 2011 for what it said were financial reasons.

Here is what the reader said in a comment posted on the “Trounson" item that appeared recently on this blog.
“The Strategic Partnership III Award reviews are in: Asterias Biotherapeutics / BioTime will get $14 million to restart spinal cord injury trial with GRNOPC1.”
The reference is to an item on the agenda for the May 29 meeting of the governing board of the $3 billion agency.

The exact title of the application is “A Phase I/IIa Dose Escalation Safety Study of [REDACTED] in Patients with Cervical Sensorimotor Complete Spinal Cord Injury.”

The information provided by the anonymous reader goes beyond what is currently available on the CIRM Web site, and he or she seems to have special knowledge of the nature of the application. That includes the names of the applicants, normally kept secret by CIRM, and the nature of the material involved in the proposal, GRNOPC1.

The staff recommendation is virtually certain to be approved by the CIRM governing board, which rarely rejects such positions.

Another $9.8 million proposal for a spinal cord therapy project was rejected by the staff. The applicants, however, may make an appeal directly to the board on May 29.

CIRM was also involved with the original Geron proposal, which was the first clinical trial for a therapy based on human embryonic stem cells. The stem cell agency loaned the company $25 million only three months before Geron bailed out on the project. It was an unpleasant surprise for the agency and shock to many patients. Geron paid back the loan with interest.

Asterias was headed by Tom Okarma, once the CEO of Geron, and BioTime is headed by Michael West, who founded Geron many years ago.

Our thanks to the anonymous reader for pointing out the information on the award.

(The day following publication of this item, Asterias reported clearing the first safety hurdle on the trial.)

(Okarma left Asterias in April. An earlier version of this item said Okarma was still head of the company.)

2 comments:

  1. Anonymous1:09 PM

    A correction to this story: Tom Okarma no longer heads Asterias. Apparently a coup took place last month that ousted Okarma and replaced him with Michael West as CEO, and 2 BioTime and Asterias board members resigned in protest (reported in April 11 and 14 SEC 8-K filings). BioTime's falling stock price and financial predicament may have been factors.

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  2. Thanks for the heads up, anonymous. We had become aware of the change earlier today but were traveling and did not have to time make the fix. We hope to have a few more details later on Okarma's departure.

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