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U.S. FDA Grants Fast Track Designation for the Development of Oragenics’ AG013 for Oral Mucositis

TAMPA, Fla.--(BUSINESS WIRE)--Oragenics (NYSE:MKT - OGEN.BC), a leader in the development of novel antibiotics against infectious disease and developing effective treatments for oral mucositis (OM), today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to AG013, the Company’s lead therapeutic candidate for the treatment of OM. Oragenics expects to file an Investigational New Drug (IND) update and initiate a Phase 2 study with AG013 in the United States and Europe in early 2017.

“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”

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Fast Track is a process designed to facilitate the development and review of drugs to treat serious conditions and address key unmet medical needs by allowing for more frequent meetings and communications with the FDA. It also provides eligibility submission of a New Drug Application (NDA) on a rolling basis as well as Accelerated Approval and Priority Review.

“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,” said Alan Joslyn, Oragenics’ Chief Executive Officer and President. “This is another significant milestone in the path providing a new therapy for cancer patients who develop oral mucositis.”

AG013 is an ActoBiotics™ therapeutic candidate formulated as a convenient oral rinsing solution and designed by Intrexon Corporation (NYSE: XON) to deliver the therapeutic molecule Trefoil Factor 1 (TFF1) to the mucosal tissues in the oral cavity. Trefoil Factors are a class of peptides involved in protection of gastrointestinal tissues against mucosal damage and have an important role in subsequent repair. In addition to this Fast Track designation...


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