Message boards index | Help | Search messages | Sign in


+ UKCAB + Public area + News, events, announcments + IPM Briefing on vaginal microbicide ring licensing. 14 May, Positive East, 12:30

IPM Briefing on vaginal microbicide ring licensing. 14 May, Positive East, 12:30

Print
Pages: 1

Gus Cairns
Member
Posts: 257
IPM Briefing on vaginal microbicide ring licensing. 14 May, Positive East, 12:30
Posted on: May 5 2015, 04:56 pm

Dear all,
Here is an invitation from Derek Bodell, IPM consultant (and long-ago Chief Executive of NAT) inviting you to a briefing session on progress towards a vaginal ring microbicide for women. Please RSVP to Derek if interested.
Gus

*****

The International Partnership for Microbicides (IPM) would like to invite you to a briefing at the offices of Positive East from Leonard Solai IPM’s Director, External Affairs (Africa) titled The Dapivirine Ring Licensure Programme -   Engaging communities and advocates in microbicide trials.

Leonard has been part of the team that have recruited and supported participants in The Ring Study, a collaboration between IPM and the Microbicide Trials Network (MTN) to conduct parallel Phase III long-term safety and efficacy studies of the monthly dapivirine ring as part of IPM's Dapivirine Ring Licensure Program. Efficacy results are expected by late 2015 or early 2016.

If the trials show efficacy and safety it will provide women with a female controlled prevention tool that is discreet and can be used even in circumstances where a partner may reject using condoms, as faced by many female sex workers among others.   

The meeting is on Thursday 14th May and will start at 1.00pm with lunch provided from 12.30. Positive East is at 159 Mile End Road, Stepney Green, London E1 4AQ :
http://www.positiveeast.org.uk/

 It would be helpful for the catering if you could confirm your attendance to me at: dbodell@ipmglobal.org
 
Derek Bodell
IPM Consultant
 
Tel:             +44(0)1535 655616
Mobile:     +44(0)7779169903
 
Email:        dbodell@ipmglobal.org
 
Background:
What Are Microbicides?
Microbicides are biomedical products being developed to protect healthy people from becoming infected with HIV during sex. Some microbicides are being designed only for women as vaginal products, and others would be rectal products that both men and women could use.
Filling a gap in current prevention strategies
Microbicides will fill an important gap in current prevention strategies by giving women a discreet tool they can use to protect themselves against HIV. They will also complement existing HIV prevention strategies when they can be used.
IPM is among several nonprofit product developers focused on developing vaginal microbicides to protect women against HIV during sex with a male partner.
Why ARV-based microbicides?
Research shows that the same types of antiretroviral (ARV) drugs already being used successfully to treat HIV/AIDS can offer protection against HIV when used consistently.
What forms will ARV-based microbicides take?
They would take many forms which women could use easily and discreetly, including sustained-release rings that could provide protection for a month at a time and vaginal gels used around the time of sex. Learn more about developing products that meet women’s preferences.
most clinically advanced microbicide candidate is dapivirine, also known as TMC120. Dapivirine is a highly potent ARV drug that acts as a non-nucleoside reverse transcriptase inhibitor (NNRTI).
How does dapivirine work?
As an NNRTI, dapivirine works by preventing HIV from replicating its genetic material after the virus enters a healthy cell.
What dosage forms of dapivirine are in development?
IPM is evaluating dapivirine-based products in three dosage forms: a monthly vaginal ring, now in parallel Phase III trials, a 90-day vaginal ring that combines dapivirine with a contraceptive, and a once-daily gel.
What is dapivirine’s clinical history?
Developed by Janssen Sciences Ireland UC (formerly Tibotec Pharmaceuticals), one of the Janssen Pharmaceutical Companies, dapivirine was initially tested as an oral treatment for HIV in 11 Phase I/II clinical trials. In 2004, Tibotec granted IPM a non-exclusive, royalty-free license to develop dapivirine as a microbicide for use in resource-poor countries, and IPM began its work on the monthly dapivirine ring. This agreement expanded in 2014, when Janssen granted IPM exclusive worldwide rights to dapivirine.
How is dapivirine being tested in IPM clinical trials?
IPM has studied the compound in 16 Phase I/II clinical trials in Africa, Europe and the United States. In all Phase I and Phase I/II studies to date, dapivirine has been found to be safe and well-tolerated, providing the basis for larger studies that will determine if IPM's dapivirine vaginal ring is safe and effective in preventing HIV. IPM and clinical trial partner the Microbicide Trials Network (MTN) are conducting parallel Phase III long-term safety and efficacy studies of the monthly dapivirine ring as part of IPM's Dapivirine Ring Licensure Program, with efficacy results expected by 2016.   
Could dapivirine be combined with other ARV microbicide candidates?
IPM is also developing dapivirine in combination with the drug maraviroc, an ARV that targets the CCR5 receptor and works by preventing the virus from attaching to healthy cells.
Could dapivirine be combined with drugs that combat other health risks?
IPM is also developing a 90-day vaginal ring that combines dapivirine with a contraceptive hormone called levonorgestrel. This multipurpose prevention technology could provide women with a single product that simultaneously prevents against the dual risks of HIV and unintended pregnancy.

Leonard Solai serves as the Director of External Affairs (Africa) at the IPM. From IPM’s office in Paarl, South Africa, Leonard is responsible for increasing awareness of and support for the development of microbicides as a promising HIV prevention tool in Africa and for engaging governments, local authorities, community leaders, and other key stakeholders in these efforts. He manages the communications activities and community engagement program for IPM’s pivotal Phase III clinical trial, The Ring Study. Leonard has worked at leading communications consultancies in Southern Africa, leading various healthcare and pharmaceutical projects for organizations such as the International AIDS Society (IAS), Secure the Future (A Bristol Myers Squibb HIV program) and Glaxo SmithKline (malaria product launch), among others, in many African regions. Prior to joining IPM, he worked closely with the governments of KwaZulu Natal and Eastern Cape in South Africa as lead consultant on their extensively drug-resistant tuberculosis (XDR-TB) programs where he led large knowledge, awareness, perceptions and behavior studies, developed strategies and oversaw implementation of advocacy, communications and social mobilization programs. He has worked closely with the government of South Africa – twice leading the National communications qualitative study commissioned by the Presidency of South Africa. Leonard holds an MBA in marketing and product development from the University of Cape Town and Erasmus Universiteit’s Rotterdam School of Management, as well as a Bachelor of Science (Honours) in Sports Medicine from the University of Cape Town.
Logged

Print
Pages: 1

+ UKCAB + Public area + News, events, announcments + IPM Briefing on vaginal microbicide ring licensing. 14 May, Positive East, 12:30