Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.VentiRx Pharmaceuticals has completed the patient enrollment in GOG-3003, a Phase II study 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.
Subscribe to our email newsletter
GOG-3003 (NCT01666444) is one of the two Phase II clinical trials of VTX-2337 currently in progress. The Phase II GOG-3003 study is being conducted in collaboration with the Gynecologic Oncology Group (GOG) Partners Program.
According to VentiRx Pharmaceuticals, the Phase II GOG-3003 study has randomized over 290 patients at over 85 institutions throughout North America. In this study, women were randomized to receive PLD plus VTX-2337 or PLD plus placebo. Overall survival is the primary endpoint of the study.
VentiRx Pharmaceuticals has also announced the designation of Orphan Drug Status by the US Food and Drug Administration to VTX-2337 for the treatment of ovarian cancer.
VTX-2337 is an investigational small molecule that targets Toll-like receptor 8 (TLR8). The TLR8 agonist directly activates multiple components of the innate immune system resulting in the production of high levels of mediators known to orchestrate the integration of innate and adaptive antitumor responses.
A recently completed Phase 1b study (GOG-9925, NCT01294293) has reported encouraging data with PLD and VTX-2337 in the treatment of platinum-resistant ovarian cancer.
VentiRx president and Dr CEO Robert Hershberg noted that 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 the company in the development of its novel immunomodulator VTX-2337.
"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," Dr Hershberg added.