Corporate Banner
Satellite Banner
Scientific Community
Become a Member | Sign in
Home>News>This Article

Kiadis Pharma Completes Five-year Follow-up of its Phase I/II Clinical Study with Blood Cancer Product ATIR™

Published: Tuesday, September 17, 2013
Last Updated: Tuesday, September 17, 2013
Bookmark and Share
67% survival demonstrated after 5 years and no transplant related mortalities.

Kiadis Pharma B.V. announced that the fiveyear follow-up of patients with high-risk malignancies from its Phase I/II clinical study confirms long-term safety and efficacy of ATIR™ over a broad dose range. ATIR™ is a cell-based product designed to enable stem cell transplantations from partially mismatched (haploidentical) family donors for patients who do not have a standard of care stem cell donor available. The results demonstrate proof of concept and show that ATIR™ infusion after a T-cell depleted haploidentical hematopoietic stem cell transplantation (HSCT) provides immune protection shortly after the transplantation and improves long-term outcome in high-risk patients with very poor prognosis.

Not only does the study confirm that ATIR™ provides an effective treatment for patients for whom a standard of care stem cell donor is not available, the long term survival even seems to compare favorably to patients who do have a standard of care matched unrelated donor available. The overall survival of patients with high-risk malignancies in the Phase I/II study who received an efficacious dose of ATIR™ was 78% and 67% after one and five years, respectively. Data from the Center for International Blood & Marrow Transplant Research (CIMBTR) show that the one (and five) year survival of patients with acute myeloid leukemia (AML) who do have a standard of care matched unrelated donor available, varies from 65% (and 35%) in low-risk patients to 45% (and 20%) in high-risk patients, respectively.

In this Phase I/II study, 19 high-risk leukemia patients were treated with escalating doses of ATIR™ after a haploidentical HSCT. The five-year follow-up data show no transplant related mortality in the nine patients who received an efficacious dose of ATIR™. In addition, no Grade III-IV (life-threatening) acute Graft versus Host Disease (GvHD) was observed at any dose, which again compares favorably to standard of care matched unrelated donor transplantations, where (according to data from the CIBMTR) incidence of life-threatening GvHD is 30%. The strong five-year survival data also suggest that immune cells responsible for the Graft versus Leukemia effect are retained in ATIR™.

The results of the study allowed selecting the optimal ATIR™ dose for further development. Data from this five-year study will be published in due course in a peer-reviewed medical journal.
An international multi-center Phase II study including patients with AML, acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS), to confirm and extend the data from the Phase I/II study, is now ongoing with topline results of the first phase expected in H1 2014.

Manfred Ruediger, PhD, Chief Executive Officer of Kiadis Pharma, commented: "The results from this study, which spans five years, show that ATIR™ might change the way in which patients with hematological malignancies will be treated. These data show that ATIR™ not only prevents significant infections without eliciting life-threatening GvHD, but also strongly improves survival rates in patients with high-risk malignancies and very poor prognosis. Our currently ongoing international Phase II clinical study is designed to confirm and extend these data to expedite moving ATIR™ towards regulatory approval."

Dr. Denis-Claude Roy, Professor of Medicine at the University of Montreal and principal investigator for the study, added: "We are very excited about the long-term effects of ATIR™. In demonstrating very strong efficacy in minimizing posttransplantation risks and improving overall survival, these longterm data represent a potential major advancement in providing patients for whom a suitable matched donor is not available, with the opportunity to receive an HSCT from a mismatched family member with ATIR™ added as an adjunctive treatment."

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,600+ scientific posters on ePosters
  • More than 3,800+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Kiadis Pharma Receives Regulatory Approval from Health Canada
Company has received No Objection Letter for its new clinical study with ATIR™.
Thursday, February 28, 2013
Scientific News
Tolerant Immune System Increases Cancer Risk
Researchers have found that individuals with high immunoCRIT ratios may have an increased risk of developing certain cancers.
Developing a Gel that Mimics Human Breast for Cancer Research
Scientists at the Universities of Manchester and Nottingham have been funded to develop a gel that will match many of the biological structures of human breast tissue, to advance cancer research and reduce animal testing.
New Gene Therapy for Vision Loss From a Mitochondrial Disease
NIH-funded study shows success in targeting mitochondrial DNA in mice.
Predictive Model for Breast Cancer Progression
Biomedical engineers have demonstrated a proof-of-principle technique that could give women and their oncologists more personalized information to help them choose options for treating breast cancer.
Specific Variations in RNA Splicing Linked to Breast Cancer
Researchers have identified cellular changes that may play a role in converting normal breast cells into tumors. Targeting these changes could potentially lead to therapies for some forms of breast cancer.
Gene Expression: A Snapshot of Stem Cell Development
New genes found that regulate development of stem cells.
Assessing Cancer Patient Survival and Drug Sensitivity
RNA editing events another way to investigate biomarkers and therapy targets.
Editing Genes to Create HIV Killers
Seattle scientists have managed to genetically transform human cells in the lab from HIV targets to HIV killers, and the technique could have implications for cancer and other diseases.
Researchers Disguise Drugs As Platelets to Target Cancer
Researchers have for the first time developed a technique that coats anticancer drugs in membranes made from a patient’s own platelets.
A New Single-Molecule Tool to Observe Enzymes at Work
A team of scientists at the University of Washington and the biotechnology company Illumina have created an innovative tool to directly detect the delicate, single-molecule interactions between DNA and enzymatic proteins.

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,600+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos