Galera Therapeutics announced that a late-stage trial for its drug designed to treat the side effects of radiation therapy in patients with head and neck cancer failed to meet its primary endpoint.
Results came from the phase 3 ROMAN trial of avasopasem manganese (avasopasem) for severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) undergoing standard-of-care radiotherapy. Oral mucositis is a side effect of radiation therapy characterized by severe pain, inflammation, ulceration and bleeding of the mouth.
The ROMAN trial is a randomized, double-blind, placebo-controlled trial in 455 patients with locally advanced HNC receiving seven weeks of standard-of-care radiotherapy plus cisplatin.
The results come as a disappointment to the Pennsylvania-based biotech considering the data in previous trials showed reductions in the incidence, duration and severity of SOM. "We are surprised and disappointed that the trial did not achieve statistical significance in its primary endpoint," said Galera’s president and CEO, Mel Sorensen, M.D.
The company said they will continue to analyze the results.