Navigation Links
First human gets new antibody aimed at hepatitis C virus

Boston, Mass. 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 liver transplant 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 liver transplantation, 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 liver failure, 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 antibodies 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."


Contact: Michael Cohen
University of Massachusetts Medical School

Related biology news :

1. Which came first, the moth or the cactus?
2. First all-African GM crop is resistant to maize streak virus
3. Scientists retrace evolution with first atomic structure of an ancient protein
4. CU-Boulder team discovers first ancient manioc fields in Americas
5. First finding of a metabolite in 1 sex only
6. First orchid fossil puts showy blooms at some 80 million years old
7. First individual genome sequence published
8. U of M begins nations first clinical trial using T-reg cells from cord blood in leukemia treatment
9. UNH becomes first university in nation to use landfill gas as primary energy source
10. Scientists in first global study of poison gas in the atmosphere
11. Weight gain between first and second pregnancies associated with increased odds of male second child
Post Your Comments:
(Date:5/12/2016)... , a brand of Troubadour Research & ... Q1 wave of its quarterly wearables survey. A particular ... a program where they would receive discounts for sharing ... "We were surprised to see that so many ... CEO of Troubadour Research, "primarily because there are segments ...
(Date:4/28/2016)... , April 28, 2016 First quarter 2016: ... up 966% compared with the first quarter of 2015 ... SEK 589.1 M (loss: 18.8) and the operating margin was 40% ... 0.32) Cash flow from operations was SEK 249.9 M ... revenue guidance is unchanged, SEK 7,000-8,500 M. The operating ...
(Date:4/15/2016)... 15, 2016  A new partnership announced today ... underwriting decisions in a fraction of the time ... and high-value life insurance policies to consumers without ... With Force Diagnostics, rapid testing (A1C, Cotinine and ... (blood pressure, weight, pulse, BMI, and activity data) ...
Breaking Biology News(10 mins):
(Date:6/24/2016)... June 24, 2016 Epic Sciences unveiled ... cancers susceptible to PARP inhibitors by targeting homologous ... (CTCs). The new test has already been incorporated ... multiple cancer types. Over 230 clinical ... response pathways, including PARP, ATM, ATR, DNA-PK and ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Researchers at ... most commonly-identified miRNAs in people with peritoneal or pleural mesothelioma. Their findings are the ... read it now. , Diagnostic biomarkers are signposts in the blood, lung fluid ...
(Date:6/23/2016)... ... June 23, 2016 , ... UAS LifeSciences, one of the ... brand, UP4™ Probiotics, into Target stores nationwide. The company, which has been manufacturing ... to its list of well-respected retailers. This list includes such fine stores as ...
(Date:6/23/2016)... 23, 2016 /PRNewswire/ - FACIT has announced the ... biotechnology company, Propellon Therapeutics Inc. ("Propellon" or ... of a portfolio of first-in-class WDR5 inhibitors for ... as WDR5 represent an exciting class of therapies, ... medicine for cancer patients. Substantial advances have been ...
Breaking Biology Technology: