Cancer drug company wins key nod from regulators

TAMPA — Federal regulators granted a Fast Track designation to a product developed to treat oral mucositis, a painful adverse effect from chemotherapy and radiotherapy that can lead to inflammation of the digestive tract.

Tampa-based Oragenics, awarded the Fast Track designation, expects to initiate a Phase 2 study with the treatment, AG013, in the United States and Europe in early 2017, according to a statement. The U.S. Food and Drug Administration's Fast Track program is designed to facilitate the development and review of drugs to treat serious conditions and address key unmet medical needs through more frequent meetings and communications with the FDA.

“We are pleased that AG013 has received this Fast Track designation which aims to help get important new drugs for unmet clinical needs to patients earlier,” says Oragenics President and CEO Alan Joslyn in the release. “This is another significant milestone in the path providing a new therapy for cancer patients who develop oral mucositis.”

Oragenics, which also develops antibiotics against infectious diseases, has an exclusive worldwide license to develop and commercialize AG013, an oral rinsing solution. It's the company's lead therapeutic candidate for the treatment of oral mucositis, the release states.