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."

For more details, go to: http://www.ventirx.com/news/VentiRx_PR_09022014_Fast_Track.pdf