A Phase 1/2 clinical trial assessing the investigational drug INCB47986 in myelodysplastic syndromes (MDS) is currently recruiting participants in the United States.
The trial is intended to establish the proper dose for the drug and whether or not it has any impact on the red blood cell counts of MDS patients. Three different dose levels will be tested during the first phase of the trial to determine which, if any, dose levels warrant further investigation based on the observed rates of improvements in red blood cell counts and the tolerability of the drug.
INCB47986, which is being developed by the pharmaceutical company Incyte, is an oral medication that belongs to a class of drugs known as JAK inhibitors. They work by inhibiting the activity of one or more of the Janus kinase family of enzymes (JAK1, JAK2, JAK3, TYK2), which are commonly mutated and overactive in inflammatory diseases, myeloproliferative disorders, and various cancers.
Two drugs in the JAK inhibitor class of drugs are already approved by the U.S. Food and Drug Administration (FDA). The first one is Jakafi (ruxolitinib), which was approved by the FDA in November 2011 for the treatment of myelofibrosis, a bone marrow disorder in which the marrow is scarred. Jakafi was also developed by Incyte. The second drug, which is being marketed by Pfizer, is Xeljanz (tofacitinib), which was approved by the FDA in November 2012 for the treatment of rheumatoid arthritis.
Participants in the Phase 2 trial of INCB47986 in MDS must be 18 years or older; have de novo MDS (meaning MDS without having had another cancer previously); be transfusion-dependent or be resistant (refractory) to, or unlikely to respond to treatment with, red blood cell-stimulating agents (erythropoiesis-stimulating agents).
Participants may not previously have received treatment with Vidaza (azacitidine) or Dacogen (decitabine) or immunosuppressive therapy for their MDS, and they may not have the del(5q) chromosomal abnormality.
For more information on the INCB47986 trial, including trial locations, please see the clinical trial description.
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In this column, I am going to tell you about my susceptibility to a specific infection prior to my myelodysplastic syndromes diagnosis and thereafter.
It is not a pleasant story, but it may nevertheless be of interest to other myelodysplastic syndromes (MDS) patients because MDS patients are at a high risk of developing infections, especially when their white blood cell counts are low.
Even before my MDS diagnosis, I had been suffering from recurrent bladder infections for decades. Why? Nobody can tell. About ten urologists have already seen my bladder …