VentiRx gets European orphan drug status for ovarian cancer drug motolimod

Motolimod is a new Toll-like Receptor 8 (TLR8) agonist that directly activates multiple components of the innate immune system, which includes human myeloid dendritic cells (mDCs), monocytes and natural killer (NK) cells.

The activation of these cells will help in the production of high levels of mediators known to orchestrate the integration of innate and adaptive anti-tumor responses.

In April 2014, the US Food and Drug Administration (FDA) granted orphan drug status to motolimod for the treatment of ovarian cancer.

VentiRx president and CEO Dr Robert Hershberg said: "Motolimod has shown encouraging initial activity as a novel immunotherapy used in combination with pegylated liposomal doxorubicin for the treatment of women with recurrent or persistent ovarian cancer who have failed a prior platinum-containing regimen.

"We believe that targeted stimulation of the innate immune system by motolimod has the potential to make a real difference for women with ovarian cancer and look forward to reporting results from the fully enrolled randomized, placebo-controlled Phase II trial.

"Data from the primary endpoint of overall survival are expected in early 2016."

Currently, motolimod is in Phase II development in both ovarian and head and neck cancer, and is being conducted in collaboration with the Gynecologic Oncology Group (GOG) Partners Program.

The company said that more than 290 women were enrolled in the GOG-3003 randomized, placebo-controlled Phase II trial of motolimod 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.