Glycostem Clinical Data Recap
January 2018 - In August of 2017, Clinical Cancer Research published a report on the positive outcome of Glycostem’s NK-killer cells phase I clinical trial, which was carried out at Radboud University Center in the Netherlands.
Ten elderly and fragile AML patients were treated in the dose escalating trial, the primary endpoint of which was safety. The goal was achieved with no exhibited side effects; not even at the highest levels of infusion.
Importantly, the treated patients’ duration of survival significantly exceeded the expected duration of survival in the general patient population. The trial results built on Glycostem’s already considerable developmental momentum as the company moves on to the next clinical stage.
Troels Jordansen, Glycostem’s CEO, stated, “We were very fortunate to have worked with Radboud’s incredibly skilful clinical staff to realise this ‘first in human’ data in AML patients. The very positive outcome, as to overall safety of the product, was expected. The greatest advantage with NK-cells is that they only attack cancerous cells.” He added, “But the strong indication of efficacy took us and many others by surprise. We were, of course, delighted with the outcome and are very driven as we move on to the pivotal clinical trials. We firmly believe we will make a huge difference in the lives of AML patients,” Jordansen concluded.
Glycostem has achieved Orphan Drug Status from EMA and FDA. For AML applications, the next clinical trial will be pivotal. This will be the final clinical trial before expected conditional product approval in 2021.
Outcome and Indications:
- oNKord® is a safe treatment -no dose limiting toxicities or Graft-versus-Host Disease observed in the study
- 5 out of 10 patients survived•Oldest surviving patient is 60 months (5 years) from date of treatment
- 1-year survival = 80%•Median survival = 22 months
- Median follow-up = 48 months (based on 5 surviving patients)
- oNKord® cells show in vivo survival, expansion and further maturation
- oNKord® cells home to the bone marrow and target leukaemia cells
- oNKord® resulted in strong reduction of residual diseaseas well as
- Prolonged Progression Free Survival and Overall Survival as compared to historical data