Trial Conducted in Collaboration with Gynecologic Oncology Group Partners Program
SEATTLE, Oct. 22, 2012 /PRNewswire/ -- VentiRx Pharmaceuticals, Inc. announced today the initiation of a randomized, placebo-controlled, Phase 2 trial evaluating VTX-2337 in combination with Doxil® (pegylated liposomal doxorubicin) in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer who have failed prior platinum-based chemotherapy. The trial will investigate whether combining VTX-2337 with Doxil®, a standard second-line chemotherapy for ovarian cancer patients, has the potential to improve survival outcomes compared to Doxil® alone in this patient population.
The randomized, double-blind, placebo-controlled Phase 2 trial is being conducted in collaboration with the Gynecologic Oncology Group (GOG) Partners Program. The trial will enroll approximately 210 patients. The primary endpoint of the trial is overall survival. Secondary endpoints include progression-free survival as determined by Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST). More information on this trial is available at clinicaltrials.gov.
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 anti-tumor responses.
Results from preclinical models suggest that combining VTX-2337 with Doxil® may provide a synergistic effect in stimulating a variety of immune pathways associated with anti-tumor activity. A recently completed Phase 1 trial in this same study population demonstrated that the combination was safe and well-tolerated.
"We are excited to have the option of combining VTX-2337 with Doxil®, a current standard of care treatment for patients who have failed a platinum-based regimen; and we are pleased that VentiRx has initiated the trial in a patient population where improved treatment regimens are desperately needed," said Bradley Monk, M.D., St. Joseph's Hospital and Medical Center, chair of the study.
"VentiRx is excited to be working with the GOG Partners Program, which provides unparalleled access to leading clinicians in order to effectively and efficiently advance research of innovative therapies like VTX-2337," said Robert Hershberg, M.D., Ph.D., Chief Executive Officer of VentiRx. "Both preclinical data and our Phase 1 studies support the combination of VTX-2337 with Doxil® and we are eager to initiate this trial. We believe the immune mediators and cellular responses induced by TLR8 activation will augment the effectiveness of Doxil and fill an unmet need in improving clinical outcomes in ovarian cancer patients with resistant or persistent disease."
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.
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.
SOURCE VentiRx Pharmaceuticals, Inc.