Kalytera Therapeutics Inc (OTCMKTS:KALTF) is jubilant on positive interim results of Phase II clinical trial of cannabidiol to prevent GVHD (graft versus host disease).
Acute GVHD is a life-threatening disease that occurs after the patients are subjected to bone marrow transplantation. The transplanted cells sometimes attack vital organs of the patient including the lungs, GI tract, skin, eyes, and liver. It is called GVHD. If it is not treated in time, the patients are prone to disability, infections, chronic illness, reduced quality of life, or even death.
The percentage of patients, who have undergone bone marrow transplant using the cells from their siblings, suffering from acute GVHD is estimated at 50%. GVHD is more prevalent in patients, who have got the bone marrow transplant with the help of cells from unrelated persons.
Kalytera is conducting the phase II clinical study on a group of 12 patients using its CBD. The patients, who received 75 mg of CBD treatment orally daily two times, have not developed grade 4 or 3 GVHD. Among the 12 patients in the study, the less severe form of GVHD â€“ grade 2 is observed in one person. The patients, who are administered CBD to prevent GVHD, have not developed any side effects. It confirms the tolerability and safety of CBD in preventing GVHD after bone marrow transplant.
Kalytera is conducting a clinical trial to evaluate the effectiveness of 75, 300, and 150 mg of cannabidiol to prevent GVHD. The drug is administered before seven days of bone marrow transplantation. Efficiency and Safety of the drug are being studied during the trial. The treatment will be continued for 98 days after the transplant.
Kalytera will continue the clinical study on three groups each consisting of 12 patients. The patients in the first group will receive 75 mg of CBD for 105 days until February 28, 2019.
Only two patients in the first cohort have expired because of unknown reasons and not due to GVHD. One patient developed Grade 2 GVHD after 91 days of treatment. It is less severe; therefore, the company is pleased with the interim results of the drug.
CEO and President of Kalytera Therapeutics, Robert Farrell said the clinical data is confirming the potential of CBD and is expected to get approval for the prevention of acute GVHD.
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