California Stem Cell Submits FDA Phase III Clinical Trial Protocol for the Treatment of Metastatic Melanoma
California Stem Cell, Inc. (“CSC”) announced today the submission of a Phase III protocol to the U.S. Food and Drug Administration (“FDA”) for a randomized, double-blind study in metastatic melanoma. The multicenter trial will examine the effectiveness of CSC’s patient specific cancer immunotherapy in patients with recurrent stage III or stage IV metastatic melanoma.
The study, led by Chief Medical Officer Robert Dillman, M.D., will explore the efficacy of subcutaneous injections of autologous dendritic cells that have been loaded with irradiated autologous tumor cells suspended in GM-CSF (“DC-TC”). The protocol calls for approximately 250 adult patients to be randomized in a 2:1 ratio to receive either the DC-TC or a control treatment. Doses will be administered weekly for three consecutive weeks, then monthly for the following five months. The primary and sole efficacy endpoint will be overall survival.
CSC’s submission of the Phase III protocol comes on the heels of two earlier Phase II clinical studies in which the combined median 5-year survival in patients with stage IV melanoma was a remarkably high 51%.
“This therapy has been proven to be safe and appears to prolong survival in late stage melanoma. We are very excited to be advancing this program into Phase III trials, so that we can further evaluate what we believe to be a very promising option for cancer patients,” said Robert Dillman, M.D., Chief Medical Officer at CSC.
About California Stem Cell
California Stem Cell Inc. (CSC) is an Irvine, CA-based company focused on the development of stem cell-based therapies for metastatic cancers, spinal muscular atrophy (SMA) and amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s Disease).
CSC has proprietary methods to generate human stem cell lines, expand them to clinically and commercially useful numbers, and differentiate them at extremely high purity using fully-defined, proprietary media and GMP processes.
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California Stem Cell, Inc.
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