Navigation Links
First human gets new antibody aimed at hepatitis C virus
Date:8/14/2009

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
Michael.Cohen@umassmed.edu
508-868-4778
University of Massachusetts Medical School
Source:Eurekalert

Related biology technology :

1. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
2. GlaxoSmithKline Recognizes University of Michigans Dr. Daniel F. Hayes as the First Recipient of the Gianni Bonadonna Breast Cancer Award
3. Kewaunee Scientific Announces First Quarter Results and Quarterly Dividend
4. Genmab Announces 2007 First Half Year Results
5. Pharsight Achieves First License Sale for Public-Source Database
6. Novare Announces First Ever Single Port Laparoscopic Kidney Removal (Nephrectomy) Using RealHand(TM) HD Instruments
7. ExonHit Therapeutics: Allergan and ExonHits First Collaboration Compound to Begin Human Clinical Trials
8. China Medical Technologies Reports First Quarter Financial Results
9. Pressure BioSciences, Inc. Issued First Patent in Canada
10. Peregrine Pharmaceuticals to Announce First Quarter FY 2008 Financial Results
11. Exelixis Reports Encouraging Interim Data From a Phase 2 Trial of XL647 as First-Line Therapy for Non-Small Cell Lung Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/19/2017)... PUNE, India , Jan. 19, 2017  Market Research Future ... The Global Market for Liquid Biopsy is growing rapidly and expected ... period. Market Highlights ... The Global Liquid Biopsy Market has been assessed as ... high growth figures and boom in the coming future. There has ...
(Date:1/19/2017)... /PRNewswire -- WuXi AppTec, a leading global pharmaceutical, ... platform, today announced that it has acquired HD ... discovery contract research organization (CRO). After completion of ... of WuXi, and will continue to focus on ... The acquisition will further strengthen WuXi,s R&D capability ...
(Date:1/19/2017)... ... January 19, 2017 , ... ... development (R&D), today announced the launch of Data Science Services , ... rapidly evolving field of precision medicine. , Data Science Services allows ...
(Date:1/19/2017)... and GAITHERSBURG, Md. , ... PIP) and Altimmune, Inc., a privately-held immunotherapeutics company ... a definitive agreement for the merger of PharmAthene ... investors include Novartis Venture Fund, HealthCap, Truffle Capital ... a fully-integrated and diversified immunotherapeutics company with four ...
Breaking Biology Technology:
(Date:12/19/2016)... España y TORONTO , 19 de diciembre de ... Biologics Inc. que permitirá el desarrollo acelerado de MSC-1, un anticuerpo ... varios tipos de tumor en 2017, con múltiples sitios previstos a ... ... con objetivo en el factor inhibidor de leucemia (LIF), una citoquina ...
(Date:12/16/2016)... YORK , Dec. 16, 2016 The global wearable ... USD 12.14 billion by 2021 from USD 5.31 billion in 2016, ... ... is mainly driven by technological advancements in medical devices, launch of ... rising preference for wireless connectivity among healthcare providers, and increasing focus ...
(Date:12/15/2016)... Dec 15, 2016 ... Research and Markets has announced the addition of ... The report forecasts the global military biometrics market to ... The report has been prepared based on an in-depth market analysis ... its growth prospects over the coming years. The report also includes a ...
Breaking Biology News(10 mins):