About Glycostem Therapeutics

Glycostem Therapeutics is a Netherlands based lifescience company advancing the science of cellular immunotherapy by creating breakthroughs in the expansion and differentiation of hematopoietic stem cells.

Glycostem Therapeutics has developed a new and innovative cell culture system for the ex-vivo generation of clinically relevant amounts of NK-cells.   

Glycostem Therapeutics pursues an open project collaboration policy towards joint development of cellular immunotherapeutics for treatment of leukemia, lymphomas and other forms of cancer.   

Recruitment Phase I trial with NK-cells for AML open

On November 1 st, 2011 our phase I study treatment of AML-patients with ex-vivo generated NK-cells has opened.

This trial is listed as HOVON-associated PLMA25 NK-cell study, see http://www.hovon.nl/studies/studies-per-ziektebeeld/aml.html?action=showstudie&studie_id=88&categorie_id=4

For an outline of the protocol see  http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2818

For patient recruitment brochure see download section of our webiste.
 
This is the first study in which NK-cells derived from Umbilical Cord Blood using Glycostem Therapeutics’ proprietary GBGM® ex-vivo expansion / differentiation technology will be applied.

In this study we will together with the University Medical Center St Radboud in Nijmegen the Netherlands, test the safety and toxicity of allogeneic NK cell infusions with an escalating dose of ex vivo expanded NK cells following immunosuppressive conditioning therapy in elderly patients with AML. 

AML-patients above 60 years, treated with intensive chemotherapy achieve complete remission (CR) rates of about 50%. However, over 75% of the patients relapse thereafter despite CR and only about 10% of those patients are still alive after 3 years.

Although allogeneic stem cell transplantation (SCT) can be curative, this option is unavailable for the majority of patients due to age and co-morbidity.

It has been demonstrated that Natural Killer (NK) cell alloreactivity can control relapse of AML without causing graft-versus-host disease (GVHD) in the setting of HLA-mismatched haploidentical allogeneic SCT. Furthermore, in non-transplant setting it has been demonstrated that allogeneic NK cell infusions can induce CR in poor-prognosis AML patients. 

Unlike existing procedures we will generate allogeneic NK cell products ex vivo from CD34+ hematopoietic progenitor cells, previously enriched from umbilical cord blood (UCB).