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news.VentiRx Pharmaceuticals has received fast track designation from the US Food and Drug Administration (FDA) for the investigation of motolimod (VTX-2337) when administered in combination with pegylated liposomal doxorubicin (PLD) to treat women with ovarian cancer.
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Motolimod is indicated for ovarian cancer patients whose disease has progressed on or recurred after platinum-based chemotherapy.
The new Toll-like receptor 8 (TLR8) immunotherapy, motolimid is currently being evaluated in two randomized, placebo-controlled Phase II trials.
VentiRx president and CEO Robert Hershberg said: "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."
Around 290 patients have been enrolled in the GOG-3003 Phase II 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 randomized, placebo-controlled GOG-3003 trial is one of two Phase II clinical trials of VTX-2337 currently underway.
The company is conducting the trial in collaboration with the Gynecologic Oncology Group (GOG) Partners Program.
Results from preclinical trials showed that the combination of VTX-2337 and PLD is expected to provide a synergistic effect in stimulating a variety of immune pathways associated with antitumor activity.
The company has recently completed a Phase I trial in the same study population, which showed that the combination was safe and well-tolerated.
Active8, the second trial in the planned Phase II trials, is a company-sponsored, randomized placebo-controlled study in patients with locally advanced and metastatic squamous cell carcinoma of the head and neck.