(Alliance News) - Mereo BioPharma Group PLC on Monday said it its drug navicixizumab has been given fast track designation in the US as a treatment for heavily pretreated ovarian cancer.
The biopharmaceutical firm said the US Food & Drug Administration gave fast track designation to navicixizumab as a treatment for "high grade ovarian, primary peritoneal or fallopian tube cancer in patients who have received at least 3 prior therapies and/or prior bevacizumab".
Mereo acquired navicixizumab in its April merger with OncoMed Pharmaceuticals Inc. The drug has completed a phase 1a study as a single therapy "in patients with various types of refractory solid tumors".
A phase 1b study of navicixizumab in combination with chemotherapy drug paclitaxel is ongoing in heavily pretreated ovarian cancer patients. Discussions over strategic partnerships to help fund the navicixizumab programme are ongoing.
Jill Henrich, senior vice president of Regulatory Affairs at Mereo BioPharma, said: "We are pleased that the FDA continues to recognize the potential of navicixizumab to become a viable new treatment option for patients with platinum-resistant ovarian cancer who failed multiple other therapies.
"This designation follows our successful type B end of phase 1 meeting with the FDA held in July 2019 regarding a potential pathway for accelerated approval for navicixizumab where the FDA agreed in principle on an outline for a Phase 2 clinical trial that could potentially support accelerated approval of navicixizumab in patients with ovarian cancer who have become resistant to prior therapies."
Fast track designation in the US means a company can communicate more frequently with the FDA during drug development, and is eligible for priority review as well as a rolling biologics licence application submission. The designation is given to drugs which treat a serious conditions which have no current treatment of where the new treatment might be better than what is available.
Shares in Mereo were down 0.8% at 59.00 pence in London on Monday morning.
By Anna Farley; annafarley@alliancenews.com
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