|By PR Newswire||
|December 5, 2013 02:01 AM EST||
AMSTERDAM, December 5, 2013 /PRNewswire/ --
~ Prior to the American Society of Hematology Annual Meeting ~
Kiadis Pharma B.V., a clinical stage biopharmaceutical company developing treatments for blood cancers, today announces that its lead product inventor, Denis-Claude Roy, MD, Professor of Medicine at the University of Montreal, is providing the following presentation: "Donor lymphocytes selectively photodepleted of alloreactive T cells can fight infections without causing GVHD" at the Haploidentical Transplantation 2013 forum in Metairie/New Orleans on December 5, 2013 prior to the annual meeting of the American Society of Hematology (ASH).
During the session, Professor Denis-Claude Roy will provide an update on Kiadis Pharma's currently ongoing international multi-center Phase II study including patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS). Professor Roy will also discuss data announced by Kiadis Pharma in September 2013 which, following the completion of its Phase I/II clinical study with ATIR™, demonstrated 67% survival after five years with no Transplant Related Mortality in the patients who received an efficacious dose of ATIR™. ATIR™ is a T-cell immunotherapy 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 demonstrated proof of concept and showed that ATIR™ infusion after a T-cell depleted haploidentical hematopoietic stem cell transplantation provides immune protection shortly after the transplantation and improves long-term outcome in high-risk patients with very poor prognosis.
The international multi-center Phase II study including patients with AML, ALL and MDS, to corroborate and extend the safety and efficacy results from the Phase I/II study, is progressing according to plan with topline data expected in the first half of 2014.
ATIR™ has been granted Orphan Drug Designation both in the EU and the USA. Together, both regions represent a combined primary market potential of more than EUR 1 billion per year.
ATIR™ is a T-cell based medicinal product enabling stem cell transplantations using partially mismatched (haploidentical) family members as donors for patients suffering from blood cancer who do not have a standard of care stem cell donor available. A hematopoietic stem cell transplantation (HSCT) is the only potentially curative option for many patients but a matching donor is available for only half of the patients in need. ATIR™ thus has the potential to address this unmet need and to make a HSCT available for all patients worldwide.
Those T-cells in a haploidentical graft which would cause Graft-versus-Host-Disease (GvHD) are selectively eliminated using proprietary technology to produce ATIR™. ATIR™ is administered as an adjunctive treatment after a T-cell depleted haploidentical HSCT facilitating early immune reconstitution without causing life-threatening (acute) GvHD.
In a Phase I/II study in which high-risk leukemia patients with very poor prognosis were treated with escalating doses of ATIR™ after a haploidentical HSCT, long- term safety, efficacy and proof of concept were confirmed in terms of absence of Grade III/IV (life-threatening) acute GvHD, reduced rates of infection, reduced Transplant Related Mortality and high Overall Survival. Positive follow-up results from this study demonstrating 67% survival after five years and no Transplant Related Mortality in the nine patients who received an efficacious dose of ATIR™ were recently reported.
About Kiadis Pharma
Kiadis Pharma B.V. is a private, clinical stage biopharmaceutical company focused on the development of innovative and potentially life-saving therapies for patients with late stage blood cancers and related disorders, an area of significant unmet medical need.
Kiadis Pharma's lead product is ATIR™, a cell based product designed to enable stem cell transplantations from partially mismatched (haploidentical) family donors. Kiadis Pharma is collaborating with internationally renowned centers in Europe and North America for the successful development and manufacturing of ATIR™. Kiadis Pharma recently obtained a GMP manufacturing license and GMP certificate for its Quality Control laboratory
Kiadis Pharma is supported by a strong group of leading international investors including LSP, Alta Partners, DFJ Esprit, Quest for Growth, MedSciences Capital and NOM. Kiadis Pharma is based in Amsterdam, The Netherlands. Further information can be found at: http://www.kiadis.com
Manfred Ruediger, CEO
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SOURCE Kiadis Pharma