Navigation Links
MassBiologics receives orphan drug status from FDA for hepatitis C treatment
Date:12/4/2013

BOSTON, MA MassBiologics of the University of Massachusetts Medical School (UMMS) has received an orphan drug designation from the U.S. Food and Drug Administration (FDA) for MBL-HCV1, a monoclonal antibody developed to prevent hepatitis C virus (HCV) recurrence in patients receiving a liver transplant.

Complications from chronic HCV infection are the most common indications for liver transplantation today. For patients with end-stage liver disease or hepatocellular carcinoma resulting from HCV infection, liver transplantation is often the only treatment option, but it is not a cure for the disease. In almost all cases, the new donor liver becomes infected with HCV soon after transplantation.

MassBiologics' monocloncal antibody, currently in a Phase 2 clinical trial, is intended to prevent HCV from damaging the transplanted liver.

"Being granted orphan drug status facilitates the goal of bringing this investigational product to patients," says Deborah C Molrine, MD, deputy director of clinical affairs at MassBiologics and professor of pediatrics at University of Massachusetts Medical School. "The economic incentives available to MassBiologics and potential commercial partners through the Orphan Drug Act will contribute greatly to bringing this monoclonal antibody to market as a treatment option for patients receiving liver transplants as a result of HCV infection."

The Orphan Drug Act was established by Congress in 1983 to aid the development of new therapies for rare medical conditions or diseases that affect less than 200,000 patients annually. To help stimulate new drug development for these less common conditions, the FDA provides financial benefits to companies that achieve orphan drug designation, including market exclusivity for 7 years, tax incentives, fee waivers and potential grant support.

Developed by MassBiologics, MBL-HCV1 is a fully human monoclonal antibody that targets a region of the hepatitis C virus on its surface envelope, preventing it from infecting liver cells. MBL-HCV1 has been shown to be safe in healthy human subjects and is currently being studied in patients with chronic hepatitis C infection undergoing liver transplantation.

"Infusions of the monoclonal antibody have been well-tolerated in transplant patients and allow for delivery of the targeted HCV treatment to begin just before the removal of the diseased liver and to continue through the early post-transplant period," said Dr. Molrine. "A Phase 2 study is underway in liver transplant patients that combines the monoclonal antibody with one of the first two oral HCV direct acting anti-virals to be licensed by the FDA. We anticipate having data to present soon on the effect of this treatment on HCV detection after liver transplantation."


'/>"/>

Contact: Jim Fessenden
james.fessenden@umassmed.edu
508-856-2000
University of Massachusetts Medical School
Source:Eurekalert

Related biology news :

1. In search for a vaccine, IU biologist receives $2.3 million to explore chlamydia genomics
2. Renowned geneticist R. Rodney Howell receives ACMG Foundation Lifetime Achievement Award
3. UF receives $1 million from Keck Foundation to study mechanisms of inherited disease
4. Gladstone scientist Warner C. Greene receives Washington University School of Medicine Alumni Award
5. Carnegies Wolf B. Frommer receives Bogorad Award for Excellence in Plant Biology
6. UC Riverside plant cell biologist receives top scientific honor
7. UC Riverside receives grant for global health and development research
8. Washington University receives $8 million to lead international childhood malnutrition effort
9. SRI Sarnoffs Iris on the Move® N-Glance™ Identification System Receives Lenel Factory Certification
10. SF State biology department receives $1.5 million to support science teaching
11. Dr. Karen Lloyd receives WHOIs Holger W. Jannasch Visiting Scholar Award
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/10/2020)... ... , ... Today CJ BIO announced the first in a series of Food ... phenomenon that is revolutionizing ingredient mixes, nutritional content and flavor profiles across a range ... 13, 2020 at11:00 AM (CDT) during SHIFT20, the virtual edition of the IFT Annual ...
(Date:7/1/2020)... ... July 01, 2020 , ... ... had completed the purchase of Teva-Takeda Pharmaceuticals’ packaging facility in Minakuchi, located in ... Japanese clinical supply facility located in Kakegawa, the new 60,000-square-foot facility will provide ...
(Date:6/25/2020)... ... June 24, 2020 , ... eClinical ... clinical data services that accelerate drug development, is collaborating with Karyopharm Therapeutics (Nasdaq: ... in hospitalized patients with severe COVID-19. This is the first study of an ...
Breaking Biology News(10 mins):
(Date:7/31/2020)... ... July 29, 2020 , ... ... transmitter systems that can be configured to drive Klystrons, TWTs, IOTs, and magnetrons. ... drive one or two switches in a push-pull configuration; yielding fast fall time ...
(Date:7/31/2020)... MIAMI (PRWEB) , ... July 29, 2020 , ... ... nearly 200 of the top radiation centers in 16 countries, has reached its ... years, SDX® is now in routine use at top universities including University of ...
(Date:7/18/2020)... ... July 16, 2020 , ... “We are thrilled to deliver this ... the only technology of its kind on the market and we were pleased that ... protective capacity of traditional cultured ingredients, creating a natural way to extend the shelf ...
(Date:7/10/2020)... ... July 09, 2020 , ... ... of Technology (MIT) has expanded the company’s exclusive license to include clinical ... the point-of-care diagnostic market, focusing initially on the SARS-CoV-2 biosensor. CANARY’s™ ...
Breaking Biology Technology: