CIRM Moves Ahead on $50 Million Clinical Trial Round

The California stem cell agency has posted its much-delayed RFA for its first foray into clinical trials – a $50 million loan/grant round that is predicted to have only three applicants.

Firms mentioned publicly as likely to seek the CIRM funds include Geron of Menlo Park, Ca.; Ipierian of South San Francisco, and Advanced Cell Technology of Santa Monica, Ca. The RFA calls for companies to receive loans of up to $25 million each if their applications are approved. Nonprofits would receive grants. CIRM said it only expects to make one or two awards, although the CIRM board could change that.

The RFA, which went up on the CIRM Web site on Aug. 24, originally was scheduled to be posted in April or May. CIRM, which touts its openness and transparency, has not responded to multiple inquiries over several months about the reasons for the delay.

The RFA calls for a successful applicant to have an approved IND, but not necessarily at the time of the review of the applications. CIRM could have delayed the RFA to give potential applicants to time to have one in the pipeline. The RFA said,

"The award recipient must have an IND that is in effect (i.e. not subject to clinical hold) for the novel cell therapy proposed for CIRM funding before issuance of notice of award.” That notice is provided by staff well after approval of an award by the board and could also possibly be delayed pending a go-ahead on an IND."

CIRM does not expect to fully fund a clinical trial, only take part in the financing. It also cannot, by law, fund activities outside of California.

The clinical trial round is part of CIRM's aggressive push to produce results that will encourage voters to approve another multibillion dollar bond measure to continue financing stem cell research with money that the state borrows.

The clinical trial RFA gives CIRM President Alan Trounson special authority to “permit exceptions to requirements specified in this section V.(eligibility) of the RFA (except for the requirement for a cell therapy derived from human pluripotent stem cells) if the president determines, in his sole discretion, that the applicant has demonstrated that the exception would preserve an important research opportunity or make a critical contribution to one of CIRM’s mission objectives.”

The RFA said the exeception requests must be filed by Sept. 29. Letters of intent are also due Sept. 29 with board approval of awards sometime next summer.