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.

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, AG013 has already been granted Orphan Drug status in the European Union.

A Phase 1B clinical trial with AG013 in 25 head and neck cancer patients at high risk for OM demonstrated that AG013 was safe and well tolerated. Data published in the journal Cancer showed a 35% reduction in the duration of ulcerative OM in AG013-treated patients versus placebo treated patients. Additionally over 30% of patients treated with AG013 were complete responders, defined as patients who did not develop OM, while all patients receiving placebo developed OM. A Phase 1 pharmacokinetic study in 10 healthy volunteers showed that live AG013 L. lactis adhered to the entire oral mucosal surface up to 24 hours after administration of the rinse.

Under an Exclusive Channel Collaboration Agreement with Intrexon, Oragenics has an exclusive worldwide license to develop and commercialize AG013 to treat oral mucositis in cancer patients.

About Oral Mucositis (OM)

OM results in a painful inflammation and mucosal ulceration in the lining of the oral cavity, throat and esophagus and is one of the most commonly reported adverse events associated with cancer chemotherapy affecting up to 500,000 patients annually. OM has a negative effect on patient well-being and if severe, negatively affects a patient’s cancer treatment regimen. At present, no drug is approved to prevent the condition broadly and current therapies are primarily palliative in nature, only addressing symptom relief but not treating the underlying causes of the condition.

About Oragenics, Inc.

We are focused on becoming the world leader in novel antibiotics against infectious disease and on developing effective treatments for oral mucositis. Oragenics, Inc. has established two exclusive worldwide channel collaborations with Intrexon Corporation, a synthetic biology company. The collaborations allow Oragenics access to Intrexon's proprietary technologies toward the goal of accelerating the development of much needed new antibiotics that can work against resistant strains of bacteria and the development of biotherapeutics for oral mucositis and other diseases and conditions of the oral cavity, throat, and esophagus. For more information about Oragenics, www.oragenics.com.

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Corporate Contact:
Michael Sullivan, 813-286-7900
Chief Financial Officer
Investor/Media Contact:
The Ruth Group
David Burke, 646-536-7009

Source: Oragenics, Inc.