Important Update Regarding CIRM’s Partnered Clinical Trial for Patients with Metastatic Melanoma

January 6, 2016

San Francisco, CA –  Today our partner, Caladrius BioSciences, discontinued its Phase 3 clinical trial evaluating a novel cell therapy for patients with metastatic melanoma, a potentially lethal form of skin cancer.

Caladrius indicated the project was terminated because outcomes for patients with the disease had improved so much since the product entered development that enrolling a sufficient number of patients in a timely manner to demonstrate a statistical benefit had become very difficult.  The product has been in development since 1990.

“CIRM exists to accelerate stem cell treatments to patients in need, however, not all clinical trials are going to be successful,” said C. Randal Mills, Ph.D., President and CEO of CIRM, California’s stem cell institute.  “Ultimately this program suffered from the excessively long development timelines common in cell therapy, a fact that further underscores the need for CIRM to work hard to create faster development pathways as called for in our new Strategic Plan.”

Under the new CIRM 2.0 milestone system, only $3 million of the $17.7 million awarded by our governing Board had been distributed to Caladrius, which matched that money with $3 million of its own. CIRM will now make the unused $14.7 million portion available to other applicants for investment into projects that accelerate stem cell therapies to patients with unmet medical needs. 

As with any terminated program, CIRM retains certain rights in the research should it later be revived.

About CIRM

At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and to act with a sense of urgency commensurate with that mission.

To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today’s most promising stem cell technologies.

With $3 billion in funding and over 280 active stem cell programs in our portfolio, CIRM is the world’s largest institution dedicated to helping people by bringing the future of medicine closer to reality.