Tuesday, May 19, 2015

NeoStem Up For $18 Million Melanoma Award from California

California's stem cell agency is expected to make an $18 million bet this week on a treatment by NeoStem, Inc., for a skin cancer that kills 10,000 persons a year in the United States alone.

Up for approval on Thursday is the company's application for an award to assist in a late stage trial that could produce a commercial product before the agency is expected to run out of money in 2020.

NeoStem is based in New York city but has operations in Irvine and Mountain View in California. It acquired California Stem Cell, Inc., in Irvine in April of 2014 for $124 million. California Stem Cell was founded by Hans Kierstead of UC Irvine, who is now president of NeoStem Oncology.

The $3 billion agency did not disclose the name of the company in keeping with its longstanding practice of concealing the identity of applicants.

However, company documents and SEC filings indicated that NeoStem was the applicant. It would be the first award by the agency to Neostem, which is a publicly traded firm.  

The summary of the agency's review posted on its Web site said the funds would go for completion of a stage three trial for a tumor stem cell-targeted immunotherapy for metastatic melanoma, which accounts for 20,000 new cases annually.

The review cited "compelling results" from the phase two stage of the trial. NeoStem has reported separately that its stage two trial had a 72 percent survival rate after two years compared to 31 percent for the control group.

NeoStem said in SEC filings that the treatment is for the most lethal form of skin cancer and has estimated market size of $1 billion.

Helping to develop a marketable product would be a big score for the agency, which has yet to fund a commerical therapy after 10 years and $1.9 billion.

Its money for new awards will run out in 2020 at its current spending rate. No additional funding sources for the agency have surfaced at this point. Being able to cite development of a commercial therapy would be likely to generate considerable enthusiasm for the agency's continued work.

Both reviewers and the CIRM staff recommended approval of the NeoStem application at the CIRM governing board meeting on Thursday.

The action came on a split vote among reviewers, 6-3-5, with six recommending funding and five against funding, according to a CIRM document.. Three reviewers said the application needed improvement.

"Reviewers considered the lack of mechanistic data and inadequate plan to gain understanding of therapeutic mechanism of action to be a major weakness and expressed concern regarding the ability of the applicant to enrol the proposal pivotal Ph3 (phase three) study as projected."
CIRM said, however, the vote and staff recommendation to fund the research "reflects both the high risk and the clear potential to impact unmet medical need."

The CIRM governing board almost never overturns approval of an award by its reviewers and staff.

The award would be one of the two first approved in CIRM's 2.0 program to fast-track cash to researchers, speed development of therapies and improve the quality of grant applications. The second award  -- $5 million -- is for work immediately leading up to a clinical trial for a therapy for retinitis pigmentosa. Shaomei Wang and Clive Svendsen at Cedars-Sinai in Los Angeles are the likely key figures in that research. Reviewers voted 15-0 to fund the work.   

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