ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) announced that the US Food and Drug Administration (FDA) has allowed the investigational new drug (IND) application for ICT-140, paving the way for conducting a clinical trial. ICT-140 is a dendritic cell vaccine targeting seven antigens that are over-expressed in ovarian cancer, as well as cancer stem cells. ImmunoCellular filed the IND application with the FDA in the fourth quarter of 2012, as planned.
"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," said Andrew Gengos, Chief Executive Officer. "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, and is anticipated to enroll approximately 20 patients with ovarian cancer who have been previously treated with standard chemotherapeutic agents, in 3-4 clinical sites in the US. ImmunoCellular anticipates initiating the trial in the second half of 2013.
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