Kalytera Therapeutics Inc (OTCMKTS:KALTF) has disclosed that it will on Tuesday hold a meeting with the Center for Drug Evaluation and Research. This happens to be one of the departments under U.S. Food and Drug Administration.
This meeting will pay a huge deal of focus on Kalytera’s much anticipated registration study. It will be a study looking into the role of cannabidiol towards the treatment of host disease versus acute graft.
Robert Farrell, current CEO of Kalytera is quite pleased with the latest developments. He termed the meeting with CDER a major step forward for them as they look forward to succeed in offering quality treatment for acute GVHD. It was a short while ago that this company submitted a number of questions to the FDA. One company official outlined that the questions were a part of the pre-IND submission package.
It is expected that in the course of this meeting CDER will provide answers to questions posed. Aside from that, it will move further to provide important details that will be useful in making future plans.
Farrell opined, “We will be in position to address any open issues or requests of CDER before submitting our IND. Once the IND is submitted and found to be acceptable to the FDA, we will initiate our planned registration study in treatment of acute GVHD.”
GVHD and its effects
The bone marrow transplant procedures are quite delicate in nature. If not handled in a proper way, a person ends up suffering from this condition called GVHD. It is a life-threatening condition that has claimed many lives over the years. It starts off by the donor cells staging attacks on the organs of the patient. Such organs could include the eyes, lungs, liver, GI tract and above all the skin.
GVHD could result in reduced quality of life, disability, infections, chronic illness and even at times death. As per this moment, FDA hasn’t yet given approval any therapy towards the treatment of acute GVHD.
FDA has made a statement outlining that it foresees the possibility using CBD products towards treatment of acute GVHD. Kalytera is also seeking to develop a working solution to help with treatment of Menstrual Cramps and Psoriasis. The future is looking bright according to one company official.