Wednesday, April 07, 2010

Geron and ACT Could Apply in $50 Million Clinical Trial Loan Program

Two more potential applicants for the California stem cell agency's $50 million clinical trial program were identified today by Nature Medicine magazine.
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In a piece by Christian Torres in its April edition, the magazine indicated that Geron of Menlo Park, Ca., and Advanced Cell Technology of Santa Monica, Ca., may well apply.

Torres wrote:
“Trials must take place in the state to qualify, and only companies or researchers with an investigational new drug (IND) application on file with the US Food and Drug Administration (FDA) are eligible for funding. Currently, that leaves only two known projects in the running: a treatment for spinal cord injury by Menlo Park–based Geron and a therapy for Stargardt’s macular dystrophy, a retinal disease, by Santa Monica–based Advanced Cell Technology.”
Earlier, iPierian, Inc., of South San Francisco was identified as another potential applicant.

The Nature magazine article indirectly raises questions about whether iPierian would be eligible for the loan program. The clinical trial proposal approved by directors last month said that applicants would be required to have an “IND filed by application deadline on the novel cell therapy derived from human pluripotent stem cells proposed for CIRM funding.”

However, during the board discussion, CIRM staff said the filing would be required three weeks prior to the grant review, probably in October. An “active” IND would be required at the time of the notice of award, which typically would be within six months of board approval of the application. CIRM President Alan Trounson would also have the ability to extend that another six months.

(The board discussion can be found beginning on page 41 of the meeting transcript.)

We are querying iPierian about its intentions.

Last month, Trounson said he knew of only three companies that would be in a position to apply for the clinical trials loans.

Torres also interviewed the co-chair of iPierian's scientific advisory board concerning the CIRM program. Torres wrote,
Deepak Srivastava(at right), director of the Gladstone Institute of Cardiovascular Disease in San Francisco(and iPierian's scientific co-chair), says the CIRM announcement is important for academic researchers who 'have faced a major road block with venture capitalists and companies, who find these therapies too risky for their appetite.'

“'With CIRM, we can finally fund this high risk, but necessary, step,' he says.”
The RFA for the clinical trial program is expected to be posted next month, with board approval of one or two applications in December.
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