Kiadis Pharma receives IND approval from FDA to start piv­otal clin­i­cal tri­al with ATIR™

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 ful­ly match­ing donor. This approval fol­lows the FDA’s deci­sion to grant ATIR™ 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™
ATIR™ 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™ 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™ 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.

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