Unfortunately for some polycythemia vera (PV) patients, current treatment options may not be fully effective or well-tolerated and may cause serious side effects.
But a promising investigational treatment is currently being clinically evaluated. Rusfertide, also known as PTG-300, is an investigational new drug designed to slow the release of iron into the bone marrow. The bone marrow needs iron to make red blood cells. With less iron, the bone marrow is not able to make as many red blood cells. As a result, rusfertide may help keep hematocrit levels under control, one of the major goals of PV treatment.
Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), and it can only be used in clinical research studies like the VERIFY study.
The purpose of the VERIFY clinical trial is to evaluate how safe and effective rusfertide is in maintaining hematocrit control and improving PV symptoms.
The VERIFY Study
This study is evaluating the safety and the potential for rusfertide to control hematocrit level, reduce, delay or eliminate the need for phlebotomy, and improve patients’ quality of life.
Participation in the VERIFY study is divided into three parts and can last up to 166 weeks (slightly over 3 years).
If you participate in the Study, you can expect to:
- Complete a screening visit with assessments to confirm you meet the study requirements.
- Continue your current PV therapy.
- Receive injections every week under the skin for up to 3 years. You will receive initial doses by the study team during a visit. You will be trained to do the injections and when you are comfortable you will do the weekly injections at home.
- Depending on how long you have been in the study, you will visit the study clinic every 2, 4, 6, or 12 weeks for study assessments.
- Attend 1 follow-up visit at the study clinic 4 weeks after your final dose of rusfertide.
You may be eligible to join the study if you are at least 18 years old, have a confirmed diagnosis of PV, and have required at least 3 phlebotomies in the last 6 months or at least 5 within the last year. For more information in participating, click here. It is always important to speak to your doctor to consider if the Study is right for you.
Study locations actively recruiting in the United States include:
- California Cancer Associates for Research and Excellence – Fresno, Fresno, California
- Marin Cancer Care, Greenbrae, California
- University of California, San Diego (UCSD) – Moores Cancer Center, La Jolla, California
- University of California, Los Angeles (UCLA) – Medical Center, Los Angeles, California
- Stanford University, Palo Alto, California
- University of Colorado – Aurora Cancer Center, Aurora, Colorado
- BRCR Medical Center, Plantation, Florida
- Moffitt Cancer Center, Tampa, Florida
- Northwest Oncology and Hematology, Rolling Meadows, Illinois
- Orchard Healthcare Research Inc, Skokie, Illinois
- University of Iowa Hospitals and Clinics, Iowa City, Iowa
- University of Kansas Cancer Center, Kansas City, Kansas
- American Oncology Partners of Maryland PA (Center for Cancer & Blood Disorders), Bethesda, Maryland
- University of Michigan, Ann Arbor, Michigan
- Cancer Care Specialists, Reno, Nevada
- New York Presbyterian Hospital/Weill Cornell Medical Center, New York, New York
- Duke University Medical Center, Durham, North Carolina
- Gabrail Cancer Center, Canton, Ohio
- MD Anderson Cancer Center, Houston, Texas
For international study locations, click here.
