VentiRx Pharmaceuticals Announces the Completion of Patient Enrollment in Randomized, Placebo-controlled Phase 2 Trial of VTX-2337 in Combination with Pegylated-Liposomal Doxorubicin in Platinum-resistant Ovarian Cancer
Company also announces designation of Orphan Drug Status by FDA for VTX-2337 in Ovarian Cancer
SEATTLE, April 17, 2014 /PRNewswire/ -- VentiRx Pharmaceuticals, Inc. today announced that enrollment has been completed in GOG-3003 (NCT01666444), a randomized, placebo-controlled Phase 2 trial of VTX-2337 in combination with Pegylated Liposomal Doxorubicin (PLD) in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer who have failed prior platinum-based chemotherapy.
VTX-2337 is a novel, investigational small molecule that targets Toll-like receptor 8 (TLR8). PLD is the standard of care for the treatment of platinum-resistant ovarian cancer and encouraging data have been reported with PLD and VTX-2337 in a recently completed Phase 1b study (GOG-9925, NCT01294293).
The Phase 2 GOG-3003 study has reached its target enrollment with more than 290 patients randomized at over 85 institutions throughout North America. The study is being performed in collaboration with the Gynecologic Oncology Group (GOG) Partners Program. Women were randomized to receive PLD plus VTX-2337 or PLD plus placebo. The primary endpoint of the trial is overall survival.
"There are limited treatments available for women with platinum-resistant ovarian cancer and completion of this study brings us closer to validating new cancer immunotherapies like VTX‑2337 as a new treatment option. We are hopeful that this novel approach of combining a selective modulator of the innate immune system with chemotherapy may extend survival for woman with ovarian cancer," said Bradley Monk, M.D., University of Arizona Cancer Center at St. Joseph's Hospital and Medical Center, chair of the study.
"Completion of enrollment in the large, randomized GOG-3003 trial and receipt of orphan drug designation for VTX-2337 in ovarian cancer are important milestones for VentiRx in the development of our novel immunomodulator VTX-2337," said Robert Hershberg, M.D., Ph.D., President and Chief Executive Officer of VentiRx. "We appreciate the tremendous effort of the GOG in the enrollment of this trial ahead of schedule, and look forward to the event-driven analysis in late 2015."
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. The study is evaluating VTX-2337 in combination with cetuximab and chemotherapy vs. cetuximab and chemotherapy alone. Progression-free survival is the primary endpoint. The Active8 trial is currently enrolling patients in the U.S. More information on this trial is available at clinicaltrials.gov (NCT01836029).
The company also announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to VTX-2337 for the treatment of ovarian cancer. Orphan Drug Designation is granted by the FDA Office of Orphan Drug Products and is given to drugs that meet certain criteria and are designed to treat a rare disease or condition affecting fewer than 200,000 people in the U.S.
VTX-2337 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.
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 The Gynecologic Oncology Group
The GOG is a national non-profit organization dedicated to clinical research in the field of gynecologic cancer. The purpose of the GOG is to improve the treatment of gynecologic cancer. These goals are addressed through research encompassing surgery, radiation therapy, chemotherapy, pathology, immunology and/or gynecologic nursing. To promote this mission, the GOG receives support from the National Cancer Institute (NCI) of the National Institutes for Health. The GOG has a history of establishing treatment standards for ovarian cancer, demonstrating improved survival with platinum therapy in the early 1980s and again with the combination of paclitaxel and platinum in the mid-1990s.
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 VTX-2337, a small molecule TLR8 agonist for the treatment of cancer. VentiRx has an exclusive, world-wide collaboration with Celgene Corporation for VTX-2337. VentiRx is a privately held organization based in Seattle, Washington. For additional information, please visit www.ventirx.com.