NEW YORK, NY / ACCESSWIRE / May 31, 2018 / Oragenics and Sigma Labs were both big winners in the biotech arena on Wednesday. Shares of Oragenics climbed higher after announcing positive results from its interim safety analysis on patients from its Phase 2 clinical trial of AG013. AG013 is a promising product for the prevention of oral mucositis in cancer patients. Shares of Sigma Labs exploded after the company announced that it had demonstrated proof of concept for closed loop quality control during metal additive manufacturing.
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Sigma Labs, Inc.
Oragenics, Inc. was one of the biggest winners on the NYSE yesterday with a close in the green of 66.67%. The stock traded around 17.1 million shares compared to an average of about 712,000 shares. Shares moved higher after the company announced positive results from its interim safety analysis as requested by FDA on patients from its Phase 2 clinical trial of AG013 for the treatment of Oral Mucositis (OM). The data was reviewed by independent Data Safety Monitoring Board (DSMB), which said that the clinical trial can proceed with no changes to the study. CEO Alan Joslyn commented, "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." Joslyn added, "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."
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Sigma Labs, Inc. shares were on a rampage in Wednesday trading, closing the day up almost 50%. The stock saw colossal trading volume compared to usual with a little over 27 million shares versus an average of about 465,000 shares. The provider of quality assurance software under the PrintRite3D® brand, announced that it has developed and demonstrated closed-loop feedback control of the metal laser powder bed fusion 3D printing process. According to the company's press release, "Using Sigma’s PrintRite3D® technology, the system operates by monitoring the process output and extracting process metrics. The process metrics are then compared to baseline metrics. The system then determines what process input parameter values need to be changed and implements those remedial changes in real time by signaling a change in the laser power in order to maintain the process under control." CTO Mark Cola remarked, "Automatic feedback process control was the next step in completing Sigma Labs’ suite of sensing, monitoring, and control capabilities of metal additive manufacturing (AM) processes." He added, "By achieving this advanced understanding of quality variation and machine learning for metal AM machines that the Factories of the Future require, Sigma Labs has demonstrated that it is possible to bring the future to the present."
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