Women diagnosed with ovarian epithelial cancer often experience persistence or recurrence of the disease following treatment with platinum-based chemotherapy. This phenomenon occurs in women within 6-12 months of completion with a platinum-based regiment. Estimates point to 22,240 novel cases of ovarian cancer in the United States, and 80% of patients will relapse after first-line treatment, according to the National Cancer Institute at the NIH. Therefore, new lines of treatment are essential.
VentiRx Pharmaceuticals, Inc., announced that their investigation with motolimod (VTX-2337), administered in combination with pegylated liposomal doxorubicin (PLD) for the treatment of recurrent or persistent ovarian cancer, received Fast Track Designation by the U.S. Food and Drug Administration (FDA).
FDA Fast Track Designation aims at expediting clinical development and submission of a New Drug Application (NDA) by promoting frequent interactions with the FDA review team. Life-threatening conditions and unmet medical needs constitute the focus of the proposal.
“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,” said Robert Hershberg, MD, PhD, President and CEO of VentiRx. “We look forward to emerging clinical data and to the possibility of providing a meaningful treatment for women with ovarian cancer.”
Motolimod (VTX-2337) — a new TLR8 immunotherapy
Motolimod, a novel Toll-like Receptor 8 (TLR8) agonist, directly activates human myeloid dendritic cells (mDCs), monocytes and natural killer (NK) cells. These multiple target activations result in a large production of mediators known to orchestrate the integration of innate and adaptive antitumor responses.
Results from preclinical models suggest that the combination of VTX-2337 with PLD may act synergistically to stimulate immune pathways shown to possess antitumor activity. The combination was demonstrated to be safe and well-tolerated, according to the results obtained in a recent completed Phase 1 trial performed in the same study population.
Motolimid is currently being evaluated in the GOG-3003, one of two placebo-controlled Phase 2 clinical trials, in combination with PLD in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer who has failed prior platinum-based chemotherapy. VentiRx has completed the enrollment of over 290 patients. The primary goal of the study is overall survival and is being performed in collaboration with the Gynecologic Oncology Group (GOG) Partners Program. FDA granted Orphan Drug designation to motolimod (VTX-2337) for the treatment of ovarian cancer in April 2014.
The second trial, called Active8, is VentiRx Pharmaceuticals Inc.-sponsored, randomized, Phase 2 placebo-controlled trial in patients with locally advanced and metastatic squamous-cell carcinoma of the head and neck (NCT01836029).
VentiRx Pharmaceuticals Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of novel Toll-like receptor 8 (TLR8) immunotherapies to be applied in the treatment of cancer, respiratory and inflammatory diseases. Motolimod (VTX-2337), a small-molecule TLR8 agonist for the treatment of cancer, is currently the company’s lead product candidate.