Kiadis Pharma Receives IND Approval From FDA to Start Pivotal Clinical Trial With ATIR(TM) in the United States
By Kiadis Pharma, PRNEWednesday, July 7, 2010
AMSTERDAM, July 8, 2010 - 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(TM) 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(TM) is designed for blood cancer patients in need of allogeneic bone
marrow transplantation, who do not have a matched donor available. ATIR(TM)
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(TM) 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(TM). These results
compare favorably to outcomes of bone marrow transplantations from a fully
matching donor.
This approval follows the FDA's decision to grant ATIR(TM) an Orphan Drug
Designation as a cell-based therapy for the reduction of Transplant Related
Mortality caused by GvHD and/or infections following allogeneic bone marrow
transplantation.
About ATIR(TM)
ATIR(TM) is a personalized cell based therapy of donor T-lymphocytes
depleted of alloreactive T-cells and is infused after a patient receives a
mismatched bone marrow transplantation to reduce Transplant Related
Mortality. ATIR(TM) is designed to prevent severe acute GvHD while providing
an early immune reconstitution to fight infections and remaining tumor cells,
thereby reducing TRM and improving overall survival.
Moreover, it enables the use of a mismatched, related (haploidentical)
donor, thus providing virtually everyone with an immediately available donor
and treatment, addressing a high unmet medical need. Today patients eligible
for an allogeneic transplantation, but without a matched donor available,
have no treatment options left. ATIR(TM) can be considered a truly
individualized medicine since it is prepared for each patient specifically.
About Kiadis Pharma
Kiadis Pharma is an oncology focused biopharmaceutical company developing
products that offer novel treatment options for terminally ill cancer
patients addressing significant unmet medical needs. The key focus indication
for Kiadis Pharma is the limitations and complications of hematopoietic stem
cell transplantation procedures.
Kiadis Pharma is located in Amsterdam, The Netherlands.
For more information about Kiadis Pharma, please visit
www.kiadis.com.
For more information please contact for: European Media, Kiadis Pharma B.V., Eefje Simpelaar, Director Communications, Email: e.simpelaar at kiadis.com, Tel: +31-20-3140250, Mob: +31-6-10829344; US Media: Jennifer James, Alta Partners for Kiadis Pharma, jjames at altapartners.com, Tel: +1(415)362-4022
Tags: Amsterdam, July 8, Kiadis Pharma, Netherlands