In March, Noreen put this out (abstract):
"today announces that it has received minutes from the Type C meeting held on January 16, 2018, between Immune Therapeutics on behalf of Cytocom, the license holder, and the US Food and Drug Administration (FDA) to discuss next steps in the development of IRT-103 a oral once-a-day an adjunct therapy to the standard of care for moderate to severe Crohn’s disease in adults and mild to severe in pediatric patients. .
IMUN CEO Noreen Griffin comments, “We are thrilled to be taking next steps in the development of Lodonal™ with the FDA. Based upon the discussion with the FDA and the minutes received following the meeting, IMUN / Cytocom intends to immediately move forward with its IND 067442 submission for the Phase 3 pivotal clinical program for moderate to severe Crohn’s disease in patients 12 and over.”
Based on the Company’s discussion with the FDA, Dr. John Abeles, Cytocom CEO, stated, “We have agreed to a number of changes to the trial protocols based on the FDA recommendations. The adult trial will now include patients 12 and over and our drug therapy will be used as an adjunct to the standard of care which will include biologists with the goal to improve outcome and safety to the standard of care existing therapies. The Division of Gastroenterology is moving away from use of CDAI and PCDAI as stand-alone endpoint measures in clinical trials and therefore, recommends that we revise our endpoints for our adult and pediatric trials.”
The Company has agreed to modify our endpoints to use the CDAI/PCDAI definition of remission as the trial’s primary endpoint and endoscopy and symptoms as the key secondary endpoints. In addition, the Company has agreed to conduct a 52-week study and will measure the primary and secondary end points at week 12. The Company has agreed to continue the trial for another 40 weeks with periodic CDAI/PCDAI and safety through week 52 and plans to use Lodonal in both adult and pediatric subjects as an adjunct to the Standard of Care. The Company will be looking for labeling for patients 12 and over for remission at 12 weeks and long-term maintenance at 52 weeks.
A significant number of Crohn’s disease patients do not reach remission with current therapies, many of which have serious side effects, and are looking for additional options,” adds Dr. Abeles. “Lodonal offers a completely different mechanism of action that has the potential to transform the Crohn’s treatment landscape and bring our innovative immunotherapy Lodonal™ to adults and children suffering from moderate to severe Crohn’s disease.”
So it says Cytocom would be enrollingin phase 3 trials "immediately". 5 months later, we are still getting nothing. Just absolutely horrible
