Bomedemstat (or IMG-7289) is a medication taken by mouth once daily that may limit the growth of cells that drive myelofibrosis. Bomedemstat is considered investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA). The FDA has granted Fast Track designation to bomedemstat for the treatment of myelofibrosis and essential thrombocythemia on the basis of results in the mouse form of the disease and early patient studies.
The IMG-7289-CTP-102 study is a study of bomedemstat (IMG-7289) in patients with myelofibrosis who no longer benefit from or cannot tolerate ruxolitinib (Jakafi®). The initial treatment period with bomedemstat lasts for 24 weeks. Participants are required to visit the clinic about 15 times during this treatment period. Visits are weekly for the first 8 weeks, then every 2 weeks for the next 8 weeks and then every month for the last 8 weeks.
There will be regular physical examinations and laboratory tests such as blood counts. In addition, there will be abdominal imaging (an MRI, or CT, as applicable) to measure spleen volume before you start taking bomedemstat and again at Weeks 12 and 24 of treatment. Bone marrow samples will also be collected before you start taking bomedemstat and at Week 24 of treatment.
If participants are receiving clinical benefit from treatment with bomedemstat at the end of 24 weeks of treatment, they may continue to receive bomedemstat for an additional 24 weeks.
You may be eligible for the study if:
For trial locations visit: https://clinicaltrials.gov/ct2/show/NCT03136185
What are clinical trials?
Clinical trials are studies of investigational drugs, known as study drugs, in healthy volunteers or patients. ‘Investigational’ means the drug has not been approved by the U.S. Food and Drug Administration (FDA). Clinical trials are performed to better understand how drugs behave in the body and how the body reacts to them. Pharmaceutical companies must test their study drugs in a series of studies known as clinical trials before requesting permission from the Food and Drug Administration (FDA) for doctors to be able to prescribe them. Depending on the type of drug being studied, healthy volunteers or patients willingly participate in these trials to establish their safety and efficacy.
Each trial follows a detailed plan (or “Protocol”) which explains all activities that occur during the trial. Additionally, clinical investigators including nurses and doctors must explain the trial to the patients and answer completely all questions patients ask. In the United States, clinical trial protocols must be reviewed and approved by the FDA, and also by an independent group called an Institutional Review Board (IRB) established to ensure the protection of the rights of research participants. The IRB does not work for the pharmaceutical company or the doctor performing the trial. Members of the IRB are scientists, doctors, lawyers and members of the public.
Why do people participate in clinical trials?
Healthy volunteers and patients participate in trials because it is possible, they could benefit from the study drug. Some take the view that participation may in the future help others with the condition. Participants can also access medical care options and diagnostic tools that might not otherwise be available to them.
Are there risks to participating in clinical trials?
With any medical research study there are risks associated with participation. There is always the possibility that the study drug may not have the desired effect on the disease being treated. Side effects are also possible. Doctors assess the potential benefits of the study drug and the risks of side effects based on previous studies and on animal studies conducted before a drug is given to humans. Doctors discuss the specific risks involved with participating in a clinical trial before allowing someone to join.
What are the different phases of clinical trials?
There are four phases of clinical trials. The trials at each phase have a different purpose and help answer different questions.
The number of people included in each stage of a trial increases from one stage to the next, with the number in any given trial depending on the disease the trial is studying.
What is "Fast Track"?
Fast Track is a designation given by FDA to some study drugs having the potential to treat a serious condition where there is an unmet medical need. Myelofibrosis remains a major unmet clinical need with few treatment options available to patients. This Fast Track designation allows the pharmaceutical company to work closely with FDA to potentially speed up the availability of new therapies to patients. Bomedemstat has Fast Track Designation form the FDA for the treatment of myelofibrosis.
How rare is myelofibrosis?
Every year, approximately 5000 new cases of myelofibrosis are diagnosed in the United States. Myelofibrosis can occur in any person at any age, but it is much more likely to be diagnosed in people over the age of 50.
What are the symptoms of Myelofibrosis?
Who is conducting the clinical study?
Imago BioSciences is a company focused on developing medicines for the treatment of bone marrow disorders including myelofibrosis, essential thrombocythemia and polycythemia vera. Imago is conducting this clinical trial with the study drug bomedemstat (also known as IMG-7289). The company was founded in 2012 and is based in California. For more information, visit www.imagobio.com.