header image

[Sign Up Now] to Receive Our FREE Daily SCVTV-SCVNews Digest by E-Mail

Inside
Weather


 
Calendar
Today in
S.C.V. History
March 28
1934 - Bouquet Canyon Reservoir, replacement for ill-fated St. Francis Dam & reservoir, begins to fill with water [story]
Bouquet Reservoir


In partnership with the Liberian government, the National Institute of Allergy and Infectious Diseases (NIAID) launched a clinical trial Friday to obtain safety and efficacy data on the investigational drug ZMapp as a treatment for Ebola virus disease. The study, which will be conducted in Liberia and the United States, is a randomized controlled trial enrolling adults and children with known Ebola virus infection.

“Although ZMapp has been used to treat several Ebola-infected patients in recent months, we cannot determine if the drug actually benefitted those patients because it was not administered within the context of a clinical trial,” said Anthony S. Fauci, M.D., director of the NIAID, at the National Institutes of Health (NIH). “This clinical trial will help us determine if ZMapp and other treatments are safe and effective for use in the current devastating outbreak in West Africa as well as in future outbreaks.”

Ebola virus buds from the surface of a Vero cell from the African green-monkey kidney epithelial cell line. Photo: National Institute of Allergy and Infectious Diseases.

Ebola virus buds from the surface of a Vero cell from the African green-monkey kidney epithelial cell line. Photo: National Institute of Allergy and Infectious Diseases.

ZMapp, developed by Mapp Biopharmaceutical Inc., based in San Diego, is composed of three different proteins called monoclonal antibodies. ZMapp is designed to prevent the progression of Ebola virus disease within the body by targeting the main surface protein of the Ebola virus. The antibodies comprising ZMapp are produced in tobacco plants specially bioengineered to produce large quantities of these proteins. Studies in nonhuman primates demonstrated that ZMapp has strong antiviral activity and rescued the animals from death as late as five days after infection with Zaire ebolavirus. The drug has not yet been tested in human clinical trials, but was administered under emergency use authorization to nine infected patients in Africa, the United States, and Western Europe.

The trial will be led by co-principal investigators Richard T. Davey, Jr., M.D., deputy clinical director of NIAID’s Division of Intramural Research, and Moses Massaquoi, M.D., National Chair for Case Management at the Ebola Incident Management System in Monrovia.  The trial will enroll adults and children of any age who have been admitted to Ebola treatment units in Liberia, health care workers who were infected with Ebola virus in West Africa and have returned to the United States for treatment, and adults and children who may have acquired Ebola infection in the United States through secondary transmission. All participants will provide informed consent prior to enrollment. Treatment centers in Monrovia, Liberia, will include the ELWA 2 Ebola treatment unit and the Monrovia Medical Unit—staffed by the Commissioned Corps of the U.S. Public Health Service. The NIH Clinical Center in Bethesda, Maryland will serve as a treatment center in the U.S. Additional trial sites under consideration in the U.S. include the Walter Reed National Military Medical Center in Bethesda, Maryland, Emory University Hospital in Atlanta, and the University of Nebraska Medical Center in Omaha, Nebraska.

All participants will receive the optimized standard of care for treating Ebola infection, which includes providing intravenous fluids, balancing electrolytes, maintaining oxygen status and blood pressure and treating other infections if they occur. Participants will then be assigned randomly to one of two groups: the first group, which will act as the control, will continue to receive the current optimized standard of care. The second group will receive the optimized standard of care plus three separate intravenous infusions of ZMapp administered three days apart. The total dose of ZMapp at each infusion will depend on the weight of the participant. Study participants will be monitored up to 30 days following discharge from the hospital and may return for outpatient visits for additional follow up.

Researchers designed the study protocol to include a series of two-arm comparisons (the first being ZMapp compared to the current standard of care) to establish a framework to evaluate multiple potential Ebola treatments in the future. If one investigational treatment proves to be statistically more effective, it will then become the basis of the new standard of care against which additional investigational Ebola interventions could be tested and compared. Each experimental therapy will be examined in up to 100 participants per arm. If scientists are unable to establish a significant difference after enrolling 100 participants per arm, then that particular treatment will be declared ineffective and scientists will begin testing the next therapy. These additional treatments may also include the following:

* Tekmira siRNA from Tekmira Pharmaceuticals Corp., based in Burnaby, British Columbia

* Favipiravir from Toyama Chemical Co. LTD, based in Tokyo, Japan

* Convalescent or post-immunization plasma collected from recent Ebola infection survivors. It is possible that this category could potentially be expanded to include plasma donors who have participated in Phase 1 Ebola vaccine clinical trials and whose plasma shows high neutralizing activity against the virus.

* BCX4430 from BioCryst, based in Durham, North Carolina

* AVI-7537 from Sarepta, based in Cambridge, Massachusetts

NIH is collaborating with experts from the University of Minnesota; Leidos Biomedical Research Inc.; Emory University Hospital; the University of Nebraska Medical Center; the Centers for Disease Control and Prevention; the U.S. Food and Drug Administration; the Uniformed Services University of the Health Sciences; and the Walter Reed National Military Medical Center to conduct this trial. The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services, is funding the production of ZMapp. The trial is expected to conclude in December 2016. Given the current decline in the number of new Ebola cases in Liberia, study investigators anticipate the need for flexibility in the conduct and design of the trial to address the changing nature of the outbreak in West Africa. Consideration will also be given to other sites in the outbreak region that express interest.

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

Comment On This Story
COMMENT POLICY: We welcome comments from individuals and businesses. All comments are moderated. Comments are subject to rejection if they are vulgar, combative, or in poor taste.
REAL NAMES ONLY: All posters must use their real individual or business name. This applies equally to Twitter account holders who use a nickname.

No Comments

    Leave a Comment


    SCV NewsBreak
    LOCAL NEWS HEADLINES
    Thursday, Mar 28, 2024
    April 16: FYI Seeks Volunteers To Pair With Local Foster Youth
    Local nonprofit Fostering Youth Independence is seeking “Allies” to support Santa Clarita youth who are aging out of the L.A. County foster care system.
    Thursday, Mar 28, 2024
    California Announces $25 Million in Awards for Youth Mental Health
    To support the mental health of California's young people, the California Department of Public Health awarded $25 million to 28 tribal and community-based organizations across the state.
    Wednesday, Mar 27, 2024
    California Launches New Youth Suicide Prevention Campaign
    The California Department of Public Health launched the “Never a Bother” campaign, a youth suicide prevention public awareness and outreach campaign for youth, young adults, and their parents, caregivers, and allies.
    Keep Up With Our Facebook

    Latest Additions to SCVNews.com
    Local nonprofit Fostering Youth Independence is seeking “Allies” to support Santa Clarita youth who are aging out of the L.A. County foster care system.
    April 16: FYI Seeks Volunteers To Pair With Local Foster Youth
    The Los Angeles County Department of Public Health today unveiled the latest L.A. County Health Survey, which gathers vital data on health behaviors, conditions, neighborhood settings, and the needs of L.A .County residents, informing future public health policies and programs.
    Public Health Unveils the 2023 L.A. County Health Survey Findings
    Due to the projected rain forecast, Eggstravaganza will now be held indoors at the Canyon Country Community Center beginning promptly at 10 a.m. on March 30.
    March 30: Eggstravaganza Now Being Held Indoors at Canyon Country Community Center
    To support the mental health of California's young people, the California Department of Public Health awarded $25 million to 28 tribal and community-based organizations across the state.
    California Announces $25 Million in Awards for Youth Mental Health
    The College of the Canyons Athletic Department will host a dedication ceremony to unveil the Michele Jenkins Softball Team Room in honor of the longtime board member and ardent softball program supporter’s nearly 40 years of service to the district.
    April 16: COC to Host Michele Jenkins Team Room Dedication Ceremony
    PFLAG Santa Clarita has announced the establishment of the Peggy and Jeff Stabile PFLAG SCV Scholarship. The scholarship will provide financial assistance to LGBTQIA+ students pursuing higher education and committed to advocating for LGBTQIA+ rights and promoting diversity and inclusion.
    PFLAG SCV Announces Stabile PFLAG Scholarship
    1934 - Bouquet Canyon Reservoir, replacement for ill-fated St. Francis Dam & reservoir, begins to fill with water [story]
    Bouquet Reservoir
    The California Department of Public Health launched the “Never a Bother” campaign, a youth suicide prevention public awareness and outreach campaign for youth, young adults, and their parents, caregivers, and allies.
    California Launches New Youth Suicide Prevention Campaign
    The Santa Clarita Master Chorale invites the community to "Let the Sunshine In," a delightful evening of food, wine and song at the annual Cabaret & Cabernet fundraising benefit.
    April 20: Santa Clarita Master Chorale’s Cabaret, Cabernet Fundraiser
    The Los Angeles County Department of Public Health cautions residents who are planning to visit the below Los Angeles County beaches to avoid swimming, surfing, and playing in ocean waters:
    March 27 Ocean Water Warning
    As an integral ingredient necessary to help the Santa Clarita Valley to flourish, feedback from the business community is the secret sauce for achieving great things.
    SCVEDEC Asks For the Business Community’s Opinion on Santa Clarita
    Raise your heart rate while raising funds for the Santa Clarita Sister Cities Dollars-for-Desks campaign to provide school desks for students in Sariaya, Santa Clarita's Sister City in the Philippines.
    April 13: Sister Cities Zumba-thon Fundraiser
    Remo, Inc. is is the world's leading manufacturer and developer of synthetic drumheads and shells. They’ve been in business for 60 years
    SCVEDC Company Spotlight: Drumming Up Big Business with Remo, Inc.
    California State Assemblywoman Pilar Schiavo (D-Chatsworth) and Assemblyman James Ramos (D-Highland) have introduced AB 3074 the "School or athletic team names: California Racial Mascots Act."
    Schiavo Introduces Bill to Prohibit ‘Derogatory’ School Mascot Names
    Los Angeles County’s Justice, Care and Opportunities Department  in collaboration with Local Initiatives Support Corporation Los Angeles is proud to announce the 2nd Annual Pitch Competition for the cohorts of JCOD's Incubation Academy.
    March 28: JCOD Incubation Academy Helps Grassroots Non-Profits For the Second Year
    Children’s Bureau is seeking foster families and now offers two virtual ways for individuals and/or couples to learn how to help children in foster care while reunifying with birth families or how to provide legal permanency by adoption.
    April 18: Children’s Bureau Hosts Virtual Orientation
    The Sunburst track was constructed in 1887 by the Southern Pacific Railroad and was a part of the main line running between San Francisco and Los Angeles.
    Enjoy Spring With a Ride On The Sunburst Track
    California State Superintendent of Public Instruction Tony Thurmond hosted a Personal Finance Summit today where he announced his support for Assembly Bill 2927 (McCarty), legislation that would require a personal finance education course for California high school graduation.
    State Superintendent Announces Support for Personal Finance Graduation Requirement
    1847 - Probable birth date of Pico Canyon oil driller Charles Alexander Mentry [story]
    C.A. Mentry
    The first Music Jam Session at The MAIN was held on Thursday, Feb. 22 and was a hit. Come out and join in for the next one on Thursday, March 28 7 p.m.-9 p.m.
    March 28: The MAIN to Host Musicians’ Jam Session
    Los Angeles County Inspector General Max Huntsman of the Office of Inspector General has issued a report entitled "Tenth Report Back on Implementing Body-Worn Cameras in Los Angeles County."
    Office of Inspector General Issues Latest Report on LASD Body Cams
    College of the Canyons women's tennis played to a convincing 7-2 conference win over Ventura College on Moica to strengthen its potential playoff resume.
    Canyons Closes Out Ventura 7-2 in Final Home Match
    Join the Santa Clarita Valley Chamber of Commerce with the Latino Business Alliance at the Cinco de Mayo Networking Celebration on Tuesday, May 7.
    May 7: Latino Business Alliance Cinco de Mayo Celebration
    SCVNews.com