Release Date: 17-Feb-2017
Oncurious NV, an oncology development company dedicated to develop innovative orphan drugs for the treatment of pediatric tumors, has received orphan drug designation for its novel product, TB-403 from European Medicine Agency (EMA) for the treatment of patients with Medulloblastoma. TB-403 is currently being examined in a Phase I/II a clinical trial for treatment of medulloblastoma, a pediatric cancer.
TB-403 is a humanized monoclonal antibody against placental growth factor (PlGF). PlGF is expressed in several types of cancer, including medulloblastoma. In medulloblastoma patients, high expression of the PlGF receptor neuropilin 1 has been shown to correlate with poor overall patient survival.
FDA's Orphan Drug Designation program provides certain incentives for companies developing therapeutics to treat rare diseases or conditions, defined as those affecting less than 200,000 individuals in the U.S. A drug candidate and its sponsor must meet several key criteria in order to qualify for, and obtain, orphan drug status. Once a drug has received orphan drug designation, the developer qualifies for a range of benefits, including federal grants, tax credits, reduction in certain regulatory fees, and the potential for seven years of market exclusivity for the drug following FDA marketing approval.
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