Therapeutics Inc (OTCMKTS:KALTF) is jubilant on positive interim results of Phase
II clinical trial of cannabidiol to prevent GVHD (graft versus host disease).
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
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.
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
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.
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.
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
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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