May 24, 2013
SOTIO has received orphan-drug designation from the U.S. Food and Drug Administration (FDA) for the active cellular immunotherapy (ACI) DCVAC/OvCa.
The autologous dendritic cells are pulsed with killed ovarian cancer cells and matured by TLR3 ligand ex vivo. The ACI product DCVAC/OvCa has shown the potential to address a significant unmet need in the treatment of ovarian cancer. SOTIO is preparing the launch of Phase II clinical trials of the ACI product DCVAC/OvCa during the second half of 2013.
Orphan status is granted for the treatment of rare diseases or conditions affecting fewer than 200,000 people in the U.S. With the designation, the FDA may provide grant funding for clinical trials, tax incentives, FDA user-fee benefits, and seven years of market exclusivity in the United States following marketing approval by the FDA. Moreover, SOTIO can apply to use an accelerated approval process potentially accelerating a new ACI product and an important advancement for patients.