First human gets new antibody aimed at hepatitis C virus

Aug 06, 2009

Building upon a series of successful preclinical studies, researchers at MassBiologics of the University of Massachusetts Medical School (UMMS) today announced the beginning of a Phase 1 clinical trial, testing the safety and activity of a human monoclonal antibody they developed that can neutralize the Hepatitis C virus (HCV).

The first volunteer received the antibody known as MBL-HCV1 on July 28, 2009, and the study is now proceeding and will eventually involve 30 healthy subjects in a dose-escalation trial expected to conclude later this year. "We are pleased that this program has now entered the clinical trial phase," said Donna Ambrosino, MD, executive director of MassBiologics and a professor of pediatrics at the Medical School. "This trial will test the safety of the antibody and measure its activity in the subjects. This will help us determine the useful dose and other parameters as we plan for the next step in this program, which will be a Phase 2 study in patients."

HCV attacks the liver and can eventually lead to liver failure. According to the U.S. Centers for Disease Control and Prevention, 3.2 million Americans are chronically infected with HCV and some 10,000 die annually of the disease. Globally, as many as 170 million people are estimated to suffer from HCV infection. For the most serious cases of HCV that do not respond to antiviral drugs, liver transplantation is the only option.

HCV is the leading indication for , diagnosed in about half of the 6,000 liver transplants done each year in the United States. Transplantation can be a life-saving treatment; however, in nearly all cases the patient's new liver is eventually infected by HCV because the virus remains in the patient's bloodstream during surgery. The powerful antiviral drugs now used to attack HCV prior to end-stage liver failure are not routinely used during surgery due to the patients' weakened condition and because of the strong medication that must be used to prevent the body from rejecting the new liver. After re-infection with HCV, nearly 40 percent of patients suffer rapid , with markedly reduced survival rates.

To close that clinical gap, the new antibody developed at MassBiologics is designed to be a therapy shortly before and after transplant surgery. By giving a patient the new antibody before and during the time when the donor liver is implanted, researchers hope the HCV virus left in the bloodstream will be neutralized and rendered unable to infect the new liver. Then, because monoclonal are highly specific and typically have little or no side-effects, additional dosages of the new antibody could, theoretically, be given immediately after transplant surgery to continue neutralizing any remaining virus.

It is also possible, researchers theorize, that the antibody could be used in combination with new antiviral drugs for treatment in patients with newly diagnosed HCV infection. "There is still more work to be done, but we are encouraged by the progress of this program to date," Dr. Ambrosino noted. "And we are grateful to the people who have volunteered to participate in this Phase 1 study. These subjects' participation will help others and advance the cause of human health."

Source: University of Massachusetts Medical School (news : web)

Explore further: Effect of topical antibiotics on antibiotic resistance, patient outcomes in ICUs

add to favorites email to friend print save as pdf

Related Stories

Novel antibody prevents infection by hepatitis C virus

May 05, 2009

Taking aim at a leading cause of liver failure in the United States, a team of scientists at the Massachusetts Biologic Laboratories (MBL) of the University of Massachusetts Medical School (UMMS) has developed a human monoclonal ...

Improved culture system for hepatitis C virus infection

Jul 16, 2008

A University of California, San Diego School of Medicine researcher has developed the first tissue culture of normal, human liver cells that can model infection with the Hepatitis C virus (HCV) and provide a realistic environment ...

Possible hepatitis C vaccine

Sep 05, 2007

Hepatitis C Virus (HCV) infects up to 500,000 people in the UK alone, many of the infections going undiagnosed. It is the single biggest cause of people requiring a liver transplant in Britain. Now, in a collaborative effort ...

Researcher Announced Cure for Hepatitis C

May 22, 2007

The use of peginterferon alone, or in combination with ribavirin, points to a cure for hepatitis C, the leading cause of cirrhosis, liver cancer and the need for liver transplant, a Virginia Commonwealth University researcher ...

Recommended for you

Africa's uneven health care becomes easy prey for Ebola

5 hours ago

Threatened by the possible spread of an Ebola epidemic which respects no borders, Africa is divided between a handful of countries equipped to withstand an outbreak and many more which would be devastated, experts say.

Ebola case stokes concerns for Liberians in Texas

6 hours ago

The first case of Ebola diagnosed in the U.S. has been confirmed in a man who recently traveled from Liberia to Dallas, sending chills through the area's West African community whose leaders urged caution ...

Is Australia prepared for Ebola?

9 hours ago

Australia needs to be proactive about potential disease outbreaks like Ebola and establish a national centre for disease control.

Dallas hospital confirms first Ebola case in US

14 hours ago

A patient at a Dallas hospital has tested positive for Ebola, the first case of the disease to be diagnosed in the United States, federal health officials announced Tuesday.

User comments : 0