FDA fast-tracks Galera drug
Galera Therapeutics Inc., a Malvern biotechnology company, said that the Food and Drug Administration recently granted "fast track" status to its investigational drug compound, known as GC4419, to reduce a painful side effect of radiation and chemotherapy, called mucositis, in head and neck cancer patients.
Galera Therapeutics Inc., a Malvern biotechnology company, said that the Food and Drug Administration recently granted "fast track" status to its investigational drug compound, known as GC4419, to reduce a painful side effect of radiation and chemotherapy, called mucositis, in head and neck cancer patients.
Galera said that it has begun enrolling 200 patients in a Phase 2b study of the drug compound, which is designed to reduce inflammation and ulceration of the mucous membranes lining the digestive tract.
Patients in the study will be given 30 mg and 90 mg doses before each radiation treatment. "If successful, GC4419 will not only reduce pain and suffering for head and neck cancer patients, but also improve their cancer treatment outcomes," said Galera CEO J. Mel Sorensen.
The FDA fast-track process aims to expedite review and approval of new drugs that treat serious or life threatening conditions. Currently, no FDA-approved drug is on the market that prevents or treats mucositis, the company said.
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