The FDA has granted Fast Track designation to VentiRx Pharmaceuticals’ motolimod (VTX-2337) when administered in combination with pegylated liposomal doxorubicin (PLD) for the treatment of women with ovarian cancer whose disease has progressed on or recurred after platinum-based chemotherapy. Motolimid is a novel TLR8 immunotherapy currently being evaluated in two randomized, placebo-controlled, phase II trials.
FDA Fast Track designation is designed to facilitate frequent interactions with the FDA review team to expedite clinical development and submission of a New Drug Application (NDA) for drugs with the potential to treat serious or life-threatening conditions and address unmet medical needs.
VentiRx has completed enrollment of over 290 patients in the GOG-3003 randomized, placebo-controlled, phase II trial of motolimod in combination with PLD in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer who have failed prior platinum-based chemotherapy. The study is being performed in collaboration with the Gynecologic Oncology Group (GOG) Partners Program. The primary endpoint of the study is overall survival. In April, the FDA granted Orphan Drug designation to motolimod (VTX-2337) for the treatment of ovarian cancer.