EMA Approves Orphan Medicinal Product Application of DCPrime’s AML Vaccine
The European Medicines Agency has issued a positive opinion recommending DCPrime’s application for orphan drug designation of dendritic cell-based cancer vaccine candidate.
Biotechnology company DCPrime has announced that the Committee for Orphan Medical Products (COMP) of the European Medicines Agency has issued a positive opinion recommending DCPrime’s application for orphan drug designation of, the company’s dendritic cell-based cancer vaccine candidate, which targets Acute Myeloid Leukemia (AML).
DCPime’s CEO and CSO Dr. Ada Kruisbeek said,"This orphan drug designation is a major step in DCPrime’s work towards approval of our AML vaccine, and clearly reflects the COMP’s view of the potential of this vaccine in improving survival of patients with AML."
"At the present time, AML patients lack an approved therapy to prevent the cancer from returning after standard chemotherapy. In 75% of the patients treated, the leukemia
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