FDA allows IND application for new ImmunoCellular Therapeutics vaccine

ImmunoCellular Therapeutics, a Los Angeles-based clinical-stage company, announced on Tuesday that the U.S. Food and Drug Administration has allowed an investigational new drug application for its dendritic cell vaccine that targets ovarian cancer.

ICT-140 is a dendritic cell vaccine that targets cancer stem cells and seven antigens that are over-expressed in ovarian cancer. ImmunoCellular filed the IND application with the FDA in the fourth quarter of 2012 to allow for a future clinical trial.

"We continue to make significant progress in advancing our development pipeline of novel cancer immunotherapies, and anticipate that in the second half of this year, we will have three active clinical programs ongoing," ImmunoCellular CEO Andrew Gengos said. "We look forward to working with our clinical investigators to conduct the clinical trial for ICT-140. Ovarian cancer remains an unmet medical need, and we believe that our approach of targeting both specific ovarian cancer antigens and cancer stem cells may offer a meaningful therapeutic benefit to patients with this disease."

The clinical trial of ICT-140 will be a Phase IIa open-label safety study to test approximately 20 patients with ovarian cancer who were previously treated with standard chemotherapeutic agents. The trial is planned for the second half of 2013.

Dendritic cell vaccines are used as part of a newly emerging form of immune therapy that involves the harvesting of blood cells from a patient, processing them in a laboratory and producing dendritic cells to give back to a patient. The process may be able to optimize the immune system against cancer.