Kiadis Pharma Announces Enrollment of First Patients in a Multinational Registration Study for ATIR(TM)
By Kiadis Pharma, PRNESunday, November 29, 2009
ATIR(TM) for Reduction of Transplant Related Mortality Following an Allogeneic Stem Cell Transplantation Using a Mismatched Donor
AMSTERDAM, November 30 - Biopharmaceutical company Kiadis Pharma announces today that the first
patients have been enrolled in its multinational registration clinical trial
with ATIR(TM). The study is designed to show reduction in transplant related
mortality (TRM) after one year following an allogeneic stem cell
transplantation with a mismatched (haplo-identical) donor in blood cancer
patients eligible for an allogeneic stem cell transplantation but without
having a matched donor available.
The study is currently open for enrollment in centers in Europe and
Canada and is designed to serve as a registration trial for European
approval.
"We are very pleased to initiate the registration study following
excellent clinical results from the phase I/II study with ATIR(TM)." says Dr.
Manja Bouman, CEO of Kiadis Pharma. "ATIR(TM) has shown a low TRM at one year
post transplantation and a high overall survival in a patient population with
no standard treatment options left. As an orphan product addressing a high
unmet need, we aim to take advantage of a fast development path for
ATIR(TM)."
"As the pioneer of ATIR(TM) I am very excited about this next major
development milestone, a multinational registration study" says Dr. Denis
Claude Roy of the University of Montreal. "I am a strong believer that
ATIR(TM) will open up a whole new treatment field for a very large patient
group which currently has no treatment options left."
About ATIR(TM)
ATIR(TM), a donor lymphocyte preparation depleted of alloreactive
T-cells, is under development to reduce transplant related mortality (TRM)
following an allogeneic hematopoietic stem cell transplantation (HSCT).
ATIR(TM) is designed to provide early immune reconstitution to fight
infections and remaining tumor cells (by eliminating the use of prophylactic
immune suppressants) while preventing acute severe (Grade III/IV) Graft
versus Host Disease. ATIR(TM) thereby significantly improves the outcome of
the transplant procedure. Moreover, it enables the use of a mismatched,
related (haplo-identical) donor, thus providing virtually everyone with an
immediately available donor and treatment, thereby addressing a high unmet
medical need as patients eligible for an allogeneic transplantation but
without a matched donor available in general have no treatment options left.
ATIR(TM) has been granted orphan drug designations from both the FDA and
the EMEA.
About Kiadis Pharma
Kiadis Pharma is an oncology focused biopharmaceutical development
company with cell based products in clinical development. The company
develops products that offer novel treatment options for terminally ill
cancer patients and address significant unmet medical needs. The key focus
indication for Kiadis Pharma is limitations and complications of bone marrow
transplantation procedures. Kiadis Pharma is located in Amsterdam, The
Netherlands. For more information about Kiadis Pharma, please visit
www.kiadis.com.
English release is provided by Kiadis Pharma. Equivalent translations
are from a third party.
For more information please contact: Kiadis Pharma B.V., Eefje Simpelaar, Director Communications, Email: e.simpelaar at kiadis.com, Tel: +31-20-3140250, Mob: +31-6-10829344
Tags: Amsterdam, Kiadis Pharma, Netherlands