FDA approves phase 3 stem cell trial for metastatic melanoma

The FDA has approved California Stem Cell’s application to start a phase 3 clinical trial to study a stem cell-based therapy to treat advanced metastatic melanoma, according to the company.

The Special Protocol Assessment indicates the FDA agrees that “design, clinical endpoints and planned clinical analyses … address regulatory objectives sufficient for market approval,” according to a press release. The FDA also granted the therapy fast track status, designed to accelerate the approval of investigational therapies that show promise in treating life-threatening medical conditions.

Two hundred fifty patients with recurrent stage III or stage IV metastatic melanoma will be enrolled in the multicenter, randomized double blind study that will compare California Stem Cell’s patient-specific cancer immunotherapy, DC-TC, against a control group. Enrollment is expected to begin in early 2014.

DC-TC therapy involves cancer stem cells that have been isolated from a patient’s resected tumor sample, enriched and inactivated. The stem cell line is combined with dendritic cells derived from the patient’s blood, and the product is subcutaneously injected into the patient. Injections will occur for 3 consecutive weeks and then once monthly for 5 months.

Researcher Robert Dillman, MD, FACP, medical oncologist at the Hoag Family Cancer Institute of Hoag Memorial Hospital Presbyterian in California, said in the release that in two phase 2 studies, the combined median 5-year survival in patients with metastatic melanoma was 51%, double that of current treatments.

“We look forward to furthering our exploration of this cancer stem cell therapy’s possible role in the successful treatment of this devastating disease, and to bringing this promising therapeutic approach to even more patients,” Dillman said.