AMSTERDAM, July 8 /PRNewswire/ — Biopharmaceutical
Company Kiadis Pharma announced today that it has received approval
for its Investigational New Drug (IND) application with the US Food
and Drug Administration (FDA) to start the pivotal clinical study
for its product ATIR™ in the
United States. Kiadis Pharma is currently enrolling
patients in a multinational, pivotal clinical study at hospitals in
Europe and Canada. With the approval of the
IND, US hospitals will also participate in this study.
ATIR™ is designed for blood cancer patients in need of
allogeneic bone marrow transplantation, who do not have a matched
donor available. ATIR™ allows a mismatched family
member to act as donor, and is being developed to reduce Transplant
Related Mortality without inducing Graft versus Host Disease
(GvHD).
“We are very encouraged by this IND approval received from
the FDA. We look forward to starting treatment of US patients in
our ongoing multinational, pivotal clinical study, in which
patients in Europe and Canada are already being
treated,“ commented Manja
Bouman, CEO of Kiadis Pharma.
ATIR™ has shown excellent clinical results in a phase I/II
study in patients who received a haploidentical mismatched bone
marrow transplantation from a family member donor. The two
year follow up data showed no Transplant Related Mortality (TRM)
and overall survival of 70% in a group of high risk leukemia
patients who received an efficacious dose of ATIR™.
These results compare favorably to outcomes of bone marrow
transplantations from a ful
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