Kiadis Pharma Provides ATIR™ Update: Two Year Follow-Up Data Show No Cases of Transplant Related Mortality – FDA grants ATIR™ Orphan Drug Status as a Medicinal Cell Based Therapy to Reduce Transplant Related Mortality

Kiadis Pharma today pro­vid­ed an update on its cell ther­a­py prod­uct ATIR™ devel­oped for mis­matched bone mar­row trans­plants.

ATIR™ con­tin­ues to show excel­lent clin­i­cal results in patients who received a mis­matched bone mar­row trans­plan­ta­tion from a fam­i­ly mem­ber donor.  The two year fol­low up data from the phase I/II study show no Transplant Related Mortality (TRM) in a group of 10 high risk leukemia patients who received an effi­ca­cious dose of ATIR™.   The over­all sur­vival of this group after two years is 70%.  These results com­pare favor­ably to out­comes of bone mar­row trans­plan­ta­tions from a full match­ing donor.

 In addi­tion, the FDA has grant­ed ATIR™ an Orphan Drug Designation as a cell based ther­a­py for the reduc­tion of Transplant Related Mortality caused by Graft ver­sus Host Disease (GvHD) and/or infec­tions fol­low­ing allo­gene­ic bone mar­row trans­plan­ta­tion. Transplant relat­ed mor­tal­i­ty is pre­dom­i­nant­ly caused by acute Graft ver­sus Host Disease (GvHD) or infec­tions.  Today, bone mar­row trans­plants require a full match between patient and donor, and pro­phy­lac­tic use of immune sup­pres­sants post trans­plan­ta­tion is essen­tial to lim­it and man­age risk of acute GvHD.  However, this approach leaves patients with­out an active immune sys­tem for a pro­longed peri­od post trans­plan­ta­tion, result­ing in increased mor­tal­i­ty due to infec­tions. ATIR™ is a cell based prod­uct of mis­matched donor immune cells from which the acute GvHD caus­ing cells have been removed.  By elim­i­nat­ing the risk of severe acute GvHD, the pro­phy­lac­tic use of immune sup­pres­sants can be avoid­ed post trans­plan­ta­tion, quick­ly giv­ing patients a func­tion­ing immune sys­tem and ulti­mate­ly result­ing in a reduced Transplant Related Mortality (TRM). 

 “The FDA’s deci­sion to grant ATIR an Orphan Drug Designation under­scores the sig­nif­i­cant poten­tial of our pro­gram for bone mar­row trans­plant patients and their fam­i­lies. We are excit­ed and encour­aged by the clin­i­cal suc­cess to date, and are focused on rapid­ly devel­op­ing ATIR to bet­ter serve this patient com­mu­ni­ty.” said Manja Bouman, CEO of Kiadis Pharma.

About ATIR™
ATIR™ is a 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™ 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 (hap­lo-iden­ti­cal) donor, thus pro­vid­ing vir­tu­al­ly every­one with an imme­di­ate­ly avail­able donor and treat­ment and 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™ can be con­sid­ered a tru­ly indi­vid­u­al­ized med­i­cine since it is pre­pared for each patient specif­i­cal­ly. 

ATIR™ is cur­rent­ly in a multi­na­tion­al, reg­is­tra­tion clin­i­cal study, with sites in Europe and Canada open for enroll­ment.

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