VentiRx's motolimod receives FDA Fast Track designation for ovarian cancer treatment

Sep 2 2014

VentiRx Pharmaceuticals, Inc., a clinical stage biopharmaceutical company committed to the development and commercialization of novel Toll-like receptor 8 (TLR8) immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of 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 2 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.

"The Fast Track designation is an important regulatory milestone for the motolimod (VTX-2337) program and underscores the potential for this novel agent to address a significant unmet medical need for women with ovarian cancer who have progressed on or recurred after receiving platinum-based chemotherapy," said Robert Hershberg, MD, PhD, President and CEO of VentiRx. "We look forward to emerging clinical data and to the possibility of providing a meaningful treatment for women with ovarian cancer."

VentiRx has completed enrollment of over 290 patients in the GOG-3003 randomized, placebo-controlled Phase 2 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 2014, the FDA granted Orphan Drug designation to motolimod (VTX-2337) for the treatment of ovarian cancer.

SOURCE VentiRx Pharmaceuticals, Inc.