Oragenics Inc. (NYSEMKT: OGEN) saw its shares practically double late on Monday, and even continue climbing after the trading session ended, following an update from the U.S. Food and Drug Administration (FDA). The agency granted Fast Track designation to AG013, the company’s lead therapeutic candidate for the treatment of oral mucositis (OM). Oragenics expects to file an Investigational New Drug (IND) update and initiate a Phase 2 study with AG013 in the U.S. and Europe in early 2017.
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.
Also 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.
In addition to this Fast Track designation, AG013 has already been granted Orphan Drug status in the European Union.
Alan Joslyn, Oragenics’ CEO and President, commented:
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. This is another significant milestone in the path providing a new therapy for cancer patients who develop oral mucositis.
For some background, 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.
Shares of Oragenics closed Monday up 81% at $0.78, with a consensus analyst price target of $ and a 52-week trading range of $0.33 to $2.12. In early trading indications Tuesday, the stock was up nearly 20% at $0.93.