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SEATTLE, Sept. 2, 2014 /PRNewswire/ -- 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.
About Motolimod (VTX-2337)
Motolimod is a novel Toll-like Receptor 8 (TLR8) agonist that directly activates multiple components of the innate immune system. This includes activation of human myeloid dendritic cells (mDCs), monocytes and natural killer (NK) cells resulting in the production of high levels of mediators known to orchestrate the integration of innate and adaptive antitumor responses.
Results from preclinical models suggest that combining VTX-2337 with PLD may provide a synergistic effect in stimulating a variety of immune pathways associated with antitumor activity. A recently completed Phase 1 trial in this same study population demonstrated that the combination was safe and well-tolerated.
GOG-3003 is one of two Phase 2 clinical trials of VTX-2337 currently underway. The second trial, called Active8, is a company-sponsored, randomized, Phase 2 placebo-controlled trial in patients with locally advanced and metastatic squamous cell carcinoma of the head and neck (NCT01836029).
About Ovarian Cancer
There will be an estimated 22,240 new cases of ovarian cancer in the United States and over 40,000 new cases in the European Union in 2014. Ovarian cancer is one of the most lethal gynecologic cancers. Women with recurrent or persistent ovarian cancer recur within 6-12 months of completion with a platinum-containing regimen and there remains a high unmet need for improved treatment options.
About VentiRx Pharmaceuticals
VentiRx Pharmaceuticals Inc. is a clinical stage biopharmaceutical company committed to the development and commercialization of novel Toll-like receptor 8 (TLR8) immunotherapies for the treatment of cancer, respiratory and inflammatory diseases. The company's lead product candidate is motolimod (VTX-2337), a small molecule TLR8 agonist for the treatment of cancer. VentiRx is a privately held organization based in Seattle, Washington. For additional information, please visit www.ventirx.com.
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SOURCE VentiRx Pharmaceuticals, Inc.