Oragenics Inc (NYSEAMERICAN: OGEN) is having an overwhelmingly strong start to the trading session this morning after the company announced clinical data. The data had to do with an interim safety analysis that proved to be overwhelmingly positive, leading to excitement among investors and sending the stock screaming for the top. Today, we’ll talk about:
- The data that was released;
- what we’re seeing from the stock as a result; and
- what we’ll be watching for ahead.
OGEN Climbs On Clinical Data
As mentioned above, Oragenics is having an overwhelmingly strong start to the trading session this morning after the company announced data. In a press release issued early this morning, the company announced positive results from an interim safety analysis that was requested by the United States Food and Drug Administration (FDA). The analysis focused on patients from its Phase 2 clinical trial of AG013 for the treatment of OM. According to the data, the company believes that overall incidence of severe OM is less than would be anticipated in the general population.
In the release, OGEN said that safety was evaluated on the basis of treatment-emergent adverse events, vital signs, weight, physical examinations, clinical laboratory assessments, and the presence of AG013 in whole blood. To date, 24 patients have been randomized and 19 patients were included in the safety evaluation. In the release, the company said that, following the review by the Data Safety Monitoring Board (DSMB), it has come to the conclusion that the clinical trial can proceed with no changes. In a statement, Alan Joslyn, President and CEO at OGEN, had the following to offer:
We are pleased with the conclusions reached by the DSMB. Of particular interest was the low number of study discontinuations due to the development of severe OM which resulted in patients seeking alternative treatments for their condition. We are also pleased to note that we believe the overall incidence of severe OM is less than would be anticipated in the general population. While recognizing the preliminary nature of this phase of the study, such a finding might well suggest mitigation of severe OM by AG013… Given the clearance by the DSMB, we will proceed with patient enrollment for our AGO13 clinical trial, which we hope to accelerate by the addition of clinical sites in the U.S. and Europe. We expect to report top-line results of the completed phase 2 trial in late 2019.
The above statement was followed up by Dr. Stephen Sonis, an expert in the field and an advisor to OGEN. Here’s what he had to offer:
The DSMB’s findings are completely in line with the safety and tolerability signals observed in patients receiving induction chemotherapy for head and neck cancer and reported in the Phase 1b trial and pave the way for completion of a robust Phase 2… The unique delivery platform by which AG013 delivers hTTF1 represents an innovative approach with the potential to favorably impact the incidence and course of this devastating side effect of radiation therapy for patients being treated for head and neck cancer.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dive into the market is that the news causes moves. In the case of Oragenics, the news proved to be overwhelmingly positive. While the FDA’s request for safety data was concerning when it happened, the stock is exploding now that the data shows that there are no safety concerns. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (9:44), OGEN is trading at $2.22 per share after a gain of $1.02 per share (85%) thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on OGEN. In particular, we’re interested in following the news surrounding the company’s continuation of the clinical trial and excited for the results, as the safety data is proving to be positive. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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