{"id":6,"date":"2011-10-14T10:29:21","date_gmt":"2011-10-14T14:29:21","guid":{"rendered":"https:\/\/www.bumc.bu.edu\/ipcp\/news8\/"},"modified":"2021-02-22T13:53:42","modified_gmt":"2021-02-22T18:53:42","slug":"news8","status":"publish","type":"page","link":"https:\/\/www.bumc.bu.edu\/ipcp\/news8\/","title":{"rendered":"News"},"content":{"rendered":"

February 3, 2021<\/strong><\/p>\n

BU Study: New Vaginal Film, MB66, is Safe and Neutralizes HIV and HSV in Vaginal Fluid for up to 24 Hours<\/strong><\/p>\n

(Boston)\u2014 While a number of topical products designed to reduce the occurrence of sexually transmitted infections have been tested with largely disappointing results, researchers at Boston University School of Medicine (BUSM), Alpert Medical School of Brown University and Mapp Biopharmaceutical have now found that MB66, a vaginal film product containing monoclonal antibodies against human immunodeficiency virus-type 1 (HIV-1) and herpes simplex viruses types 1 and 2 (HSV-1 and 2), is safe and effective.<\/p>\n

HIV-1 and HSV-1 and 2 are relatively common sexually transmitted infections associated with significant illness and sometimes even death. Though antiviral drugs can suppress viral concentrations and dramatically slow disease progression, these infections are incurable. Therefore, considerable effort is being directed toward prevention strategies.<\/p>\n

Researchers conducted a Phase 1 clinical trial to assess the safety, acceptability, drug distribution<\/span> and effectiveness of both single and repeated doses of MB66. The MB66 vaginal film multipurpose prevention product was safe, and well tolerated, both for single dose, as well as repeated dose application. In addition, effective antibody levels were detected in vaginal secretions up to 24 hours after product use and they significantly inactivated both HIV-1 and HSV-2 in laboratory tests. Women who participated in the study reported high acceptability and willingness to use the vaginal film with a majority of women reporting they would definitely use the product.<\/p>\n

\u201cThe results of our study indicate that MB66 is safe and acceptable to women. Furthermore, our data showed excellent antiviral protection for at least 24 hours after product insertion, providing evidence that MB66 is a promising multipurpose prevention technology product to protect women against HIV and HSV-2. More clinical trials are needed to ascertain the clinical efficacy and acceptability in at-risk populations. It may be necessary to add more than one anti-HIV antibody to MB66 for optimal efficacy and to avoid HIV escape mutations,\u201d said corresponding author Joseph Politch, PhD, associate professor of medicine at Boston University School of Medicine.<\/p>\n

To date, there are no effective vaccines to prevent HIV or HSV transmission. Condoms are safe and effective when used consistently and correctly but are generally perceived as a barrier to intimacy and sexual pleasure, and have relatively low acceptability among both men and women. Therefore, there is a need for products like MB66 that can provide protection on demand if used as a vaginal film or longer lasting protection in the form of a vaginal ring. \u00a0These products will also allow women to have control over their sexual health.<\/p>\n

These findings appear online in PLOS Medicine<\/em><\/a>.<\/p>\n

This research was\u00a0funded under the\u00a0Integrated Preclinical\/Clinical Program for HIV Topical Microbicides through a grant (U19 AI096398) from the NIH.<\/p>\n

\u00a0<\/strong><\/p>\n

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____________________________________________________<\/a><\/strong><\/p>\n

\"LeafBio<\/a><\/strong><\/p>\n

Clinical Trials Begin on Antibody-based Prevention of HIV and Genital Herpes<\/strong><\/h2>\n

Leaf Bio\u2019s MB66 Developed as Multipurpose Prevention Technology<\/em><\/h3>\n

January 7, 2016 \u2013 SAN DIEGO \u2013 LeafBio, Inc., the commercial arm of Mapp Biopharmaceutical, Inc., announced today that a clinical safety trial of MB66 has begun. MB66 is intended to block sexual transmission of genital herpes and HIV as a rapidly dissolving film that releases anti-viral monoclonal antibodies to the vaginal mucosa.<\/p>\n

A consortium of investigators from universities and the pharmaceutical industry is evaluating MB66.<\/p>\n

“MB66 is designed to use antibodies to protect the vaginal mucosa much the same way Mother Nature would,\u201d said Dr. Deborah Anderson, professor at Boston University and co-principal investigator of the initiative funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. \u201cIn preclinical tests, MB66 was safe and effective, and we are very pleased that a multipurpose prevention technology like MB66 has now advanced to the clinical evaluation stage.\u201d<\/p>\n

The Phase 1 safety trial is being conducted at The Miriam Hospital in Providence, Rhode Island. “We have evaluated a large number of the first generation microbicides in our clinical facilities, and are pleased to evaluate this novel technology for safety,” said Dr. Susan Cu-Uvin, professor of obstetrics-gynecology and medicine at Brown University.<\/p>\n

“Scientists have been evaluating the safety and efficacy of antibodies delivered by infusion or injection in the prevention of HIV transmission. We look forward to evaluating similar antibodies applied topically,” said Dr. Kenneth Mayer, professor of medicine at Harvard University, medical research director of the Fenway Health Center and clinical co-chair of the trial along with Dr. Cu-Uvin.<\/p>\n

\u201cThis is an exciting first step as we work toward the development of a multipurpose prevention technology that can protect against sexually transmitted infections and provide effective contraception at the same time,\u201d said Dr. Kevin Whaley, CEO of Mapp.<\/p>\n

MB66, which has been in development by Mapp since its founding in 2003, is the second LeafBio product to enter clinical trials. ZMappTM<\/sup> is currently being evaluated in an efficacy trial for the treatment of Ebola virus disease in the United States and West Africa.<\/p>\n

###<\/strong><\/p>\n

About Mapp Biopharmaceutical and LeafBio<\/em><\/strong>: Mapp Biopharmaceutical was founded in 2003 to develop novel pharmaceuticals for the prevention and treatment of infectious diseases<\/em>, focusing on unmet needs in global health and biodefense. As these products transition to clinical evaluation, LeafBio assumes ownership and commercialization responsibilities.The project described received funding from NIAID (Grant Number U19AI096398).<\/em><\/p>\n

 <\/p>\n

FOR IMMEDIATE RELEASE<\/p>\n

January 7, 2016<\/p>\n

Contact: Kerri Lyon \/ 917.348.2191<\/p>\n

klyon@skdknick.com<\/a><\/p>\n

 <\/p>\n

 <\/p>\n

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