Combination Ovarian Cancer Therapy Granted Fast Track Status

VentiRx announced that the FDA has granted Fast Track designation to 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.

Motolimod is a toll-like receptor 8 (TLR8) agonist that directly activates human myeloid dendritic cells (mDCs), monocytes, and natural killer (NK) cells.

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Motolimod is being studied in two Phase 2 randomized, placebo-controlled trials, GOG-3003 and Active8. In GOG-303, patient enrollment for motolimod in combination with PLD has been completed with over 290 patients with recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have failed prior platinum-based chemotherapy. The primary endpoint of the study is overall survival.

In April 2014, the FDA granted Orphan Drug designation to motolimod (VTX-2337) for the treatment of ovarian cancer.

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