Navigation Links
Kiadis Pharma Receives IND Approval From FDA to Start Pivotal Clinical Trial With ATIR(TM) in the United States

AMSTERDAM, July 8 /PRNewswire/ -- 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.

For more information about Kiadis Pharma, please visit

SOURCE Kiadis Pharma
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Kiadis Pharma Announces Promising Phase II Clinical Trial Results for Reviroc
2. Kiadis Pharma Announces Collaboration With the Julius Maximilians University of Wurzburg, Germany
3. Kiadis Pharma Announces Positive Clinical Results for ATIR(TM) in Mismatched Bone Marrow Transplantations
4. Kiadis Pharma Receives Two Orphan Drug Designations for Reviroc(TM) From the FDA
5. Thomson Scientific Publishes The Ones to Watch - A Quarterly Review of Phase Changes in the Pharmaceutical Pipeline
6. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
7. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
8. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
9. Clinical Trial Effectiveness: How Pharmas & Biotechs Save Cost with Savvy Investigator Management
10. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
11. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
Post Your Comments:
(Date:6/24/2016)... 2016  Arkis BioSciences, a leading innovator in ... durable cerebrospinal fluid treatments, today announced it has ... is led by Innova Memphis, followed by Angel ... investors.  Arkis, new financing will accelerate the commercialization ... release of its in-licensed Endexo® technology. ...
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... the "Pharmaceutical Excipients Market by Type (Organic Chemical ... Preservative), Formulation (Oral, Topical, Coating, Parenteral) - Global Forecast ... The global pharmaceutical excipients ... 2021 at a CAGR of 6.1% in the forecast ...
(Date:6/23/2016)... , June 23, 2016 ... CAPR ), a biotechnology company focused on the ... announced that patient enrollment in its ongoing randomized ... has exceeded 50% of its 24-patient target. Capricor ... the third quarter of 2016, and to report ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... recently awarded their highest five-star rating ... Millions of individuals in the United States and Canada wear eyeglasses. Once considered to ... correct vision and make a fashion statement. Even celebrities use glasses as a way ...
(Date:6/26/2016)... ... ... PawPaws brand pet supplements owned by Whole Health Supply is ... of felines. The formula is all-natural and is made from Chinese herbs that have ... Kidney Support Supplement Soft Chews are Astragalus Root Extract and Rehmannia Root Extract ...
(Date:6/25/2016)... TX (PRWEB) , ... June 25, 2016 , ... Austin ... of the American College of Mohs Surgery and to Dr. Russell Peckham for medical ... and highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery ...
(Date:6/25/2016)... ... , ... As a lifelong Southern Californian, Dr. Omkar Marathe earned his Bachelors ... Geffen School of Medicine at UCLA. He trained in Internal Medicine at Scripps Green ... hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had the opportunity to train ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article ... are unfamiliar with. The article goes on to state that individuals are now more ... these less common operations such as calf and cheek reduction. The Los Angeles area ...
Breaking Medicine News(10 mins):