(TM) solves the problem of not finding a matched donor in time and has the potential to make curative HSCT a viable option to many more patients.
ATIR is designed for blood cancer patients in need of allogeneic bone marrow transplantation, who do not have a matched donor available.
Kiadis reports ATIR has shown good clinical results in a Phase I/II study in patients who received haploidentical mismatched bone marrow transplantation from a family member donor.
The approval followed the FDA's decision to grant ATIR Orphan Drug Designation as a cell-based therapy for the reduction of TRM caused by GvHD and/or infections following allogeneic bone marrow transplantation.
This is an important strategic milestone in the development of ATIR as a novel approach which may enable a safe and potentially lifesaving mismatched bone marrow transplantation as a treatment option for end-stage blood cancer patients," said Dr.
ATIR is under development to prevent life-threatening GvHD, a major complication of allogeneic bone marrow transplantations.
In the study, the efficacy of ATIR
will be investigated in patients diagnosed with AML, ALL or MDS eligible for an allogeneic bone marrow transplant but for whom no matching donor is available.
The Department preferred an appeal against the said order before the ATIR
This not only attests to the quality that we have established at Kiadis Pharma, but secures the pathway to take ATIR (TM) to the next stage of development.
ATIR (TM) thus has the potential to address this unmet need and to make stem cell transplantations available for all patients worldwide.
Kiadis Pharma is currently conducting a Phase II international multi-center study with ATIR (TM), its cell based product for blood cancers, in order to confirm and extend previous Phase I/II results.
Manfred Ruediger, PhD, Chief Executive Officer of Kiadis Pharma, commented: "We are delighted to receive this credit for ATIR (TM) as these awards are only made to innovative projects with strong commercial prospects.