The University of Nebraska Medical Center is one of 62 sites nationwide and in Canada that is enrolling patients in a clinical trial, supported by the National Institutes of Health, to test a new treatment for West Nile Virus.
Alison Freifeld, M.D., an infectious diseases physician at UNMC who specializes in treating infections in patients who have received organ transplants or who have cancer, is hopeful that the medication being tested, Omr-IgG-amTM, will provide a better treatment for those affected with West Nile Virus. The NIH National Institute of Allergy and Infectious Diseases is supporting the clinical trial.
UNMC is excited to be a participant in this study. Right now, no therapy has been proven to be effective for West Nile Virus infections, said Dr. Freifeld, the principal investigator for the grant at UNMC. Were hopeful that this medication will make a positive impact in the treatment of severe West Nile virus disease. We think it will make a substantial contribution to the treatment of those afflicted with this virus.
This clinical trial is intended to test the safety and tolerability of Omr-IgG- amTM an intravenous immunoglobulin G containing high anti-West Nile Virus antibody titers in selected patients with suspected or confirmed West Nile Virus disease. Omr-IgG- amTM is expected to be effective because it contains high levels of antibodies against West Nile Virus. These high antibody levels are present in the product because it is derived from donors living in Israel, where the virus is common in the environment and people highly exposed to it.
The data from the animal testing of Omr-IgG-amTM is very compelling, Dr. Freifeld said. This is the one treatment for West Nile Virus that has the most scientific basis behind it.
Only those patients who might suffer from the most severe complications from West Nile Virus, or who already have those complications such as encephalitis or myelitis (paralysis), will be admitted to the clinical trial. Patients with these types of severe neurologic complications account for less than 1 percent of all cases of the disease, Dr. Freifeld said. Those who have a higher chance of developing neurologic problems due to West Nile are usually over 40 years old and/or have a compromised immune system, such as from a transplant, cancer treatment or a disease such as AIDS. During the clinical trial, three of every five patients will receive the Omr-IgG-amTM , while 20 percent will receive a similar antibody preparation called Polygam®, and another 20 percent will receive a placebo.
It is important for people to understand that if they do enter this clinical trial, there is a 60 percent chance that they will receive Omr-IgG-amTM and a 40 percent chance they will receive a placebo or other agent, Dr. Freifeld said. It is extremely important to do this type of randomization in order to know whether or not the new drug is really better and safer than other similar drugs, or no drug at all.
In 2003, 1,942 cases of West Nile Virus were reported in Nebraska, second only to Colorados 2,947 cases. The deaths of 29 Nebraskans were attributed to the disease. The reported case numbers do not account for all people infected with the disease, Dr. Freifeld said. She explained that 80 percent of those people who are infected with West Nile Virus have no symptoms of the disease and never know that they have it. Twenty percent of those people infected acquire West Nile fever, a flu-like illness that can last several days. Less than 1 percent of those people infected experience the most severe complications of the disease, such as involvement of the brain (encephalitis).
People interested in enrolling a patient in the study should contact Kimberly Bargenquast, research nurse coordinator at UNMC, at (402) 559-8650 or kbargenquast@unmc.edu.
In addition to UNMC, four other medical facilities in Nebraska are participating in the trial. They, along with the principal investigators at those facilities, include: Creighton University Medical Center/Veterans Affairs Medical Center, Omaha, David Dworzack, M.D.; Jennie Melham Memorial Medical Center, Broken Bow, Robert Kahnk, M.D.; Great Plains Regional Medical Center, North Platte, Mark Nielsen, M.D.,; and Community Hospital, McCook, Toby Free, M.D.