Leukos Biotech receives orphan drug designation by the FDA

by Gemma Escarré,

Leukos Biotech, spin-off of the Jose Carreras Leukaemia Research Institute supported by Inveready, has received the Food and Drug Administration (FDA) orphan drug designation for its drug candidate LK-01.

LK-01 is a product based on Apomorphine for the treatment of Acute Myeloid Leukemia (AML), a blood cancer arising from the myeloid lineage of haematopoietic stem cells. A still relevant proportion of patients with AML die from progressive disease after relapse.

The potential benefit of LK-01 is being explored in a phase I/II trial in elderly patients and relapsed patients with AML. Results are expected later in 2019.

The US FDA orphan drug designation provides incentives for companies to develop drugs for rare diseases.

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Photo: Ruth Risueño and Enrique Llaudet, CSO and CEO of Leukos Biotech respectively, in a CataloniaBio & HealthTech event.


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