International Partnership for Microbicides Advancing HIV-Prevention Options for Women Parliamentary...
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International Partnership for MicrobicidesInternational Partnership for MicrobicidesInternational Partnership for MicrobicidesInternational Partnership for Microbicides
Advancing HIV-Prevention Options for WomenAdvancing HIV-Prevention Options for Women
Parliamentary Seminar on New HIV-Prevention Parliamentary Seminar on New HIV-Prevention TechnologiesTechnologies
Dr. Zeda Rosenberg
Helsinki, 24 October 2007
The Face of HIV is Increasingly…The Face of HIV is Increasingly…The Face of HIV is Increasingly…The Face of HIV is Increasingly…
FemaleFemale
YoungYoung
Married and monogamousMarried and monogamous
A motherA mother
What is a Microbicide?What is a Microbicide?What is a Microbicide?What is a Microbicide?
Vaginal products to prevent or reduce HIV
Could be delivered in many forms:
Vaginal applicator
Vaginal ring
gel
intravaginal ring
softgel capsule
vaginal film
vaginal tablet
sponge
transmission
Microbicides in Product DevelopmentMicrobicides in Product DevelopmentMicrobicides in Product DevelopmentMicrobicides in Product Development
Free virusLactin-VInvisible Condom
AttachmentFusion
Replication(RT)
Protein synthesis and assembly
Budding
Maturation
Locus small molecules
CarraguardPRO2000SPL7013 (VivaGel)Monoclonal antibodiesDS003 (BMS)DS001 (Merck)DS006 (Maraviroc)SCHs (Schering-Plough)
S-DABODapivirine (TMC120)UC781Tenofovir (PMPA)PC815 (MIV150 + Carraguard)
IPM compounds
IPM-supported compounds
Pyrimidinediones (Samjin)
BufferGel
Integration
Microbicide Development ProcessMicrobicide Development ProcessMicrobicide Development ProcessMicrobicide Development Process
Research & Development
• Pipeline
• Basic research
• Pre-clinical studies
• Lead selection
• Community engagement
• Site selection
• Site preparation
• Site monitoring
• Incidence studies
Site Development Clinical Trials
• Pharmacokinetic
• Safety
• Efficacy
• Acceptability
Regulatory Approval
• Clinical Trials
• Licensure
• Post-licensure
studies
Launch & Access
• Manufacturing
• Service delivery
• Marketing
Early Generation MicrobicidesEarly Generation MicrobicidesEarly Generation MicrobicidesEarly Generation Microbicides
Products that non-specifically block HIV from interacting with target cells
In efficacy trials
Partial, low or no effectiveness
Short-acting (used near time of sex)
Candidate Microbicide
PhaseMechanism
of Action
Sponsor/Developer Trial Location
Carraguard 3 Entry Inhibitor
Gates, USAID /Population Council
South Africa – Cape Town, Durban, Medunsa
PRO 2000 3 Entry Inhibitor
UK Medical Research Council, DFID / MDP
South Africa – Mtubatuba, Durban, JohannesburgUganda – Masaka Tanzania – Mwanza Zambia – Mazabuka
PRO 2000 &Buffer Gel
2/2B Entry Inhibitor &Vaginal Defense Enhancer
NIAID / HPTN (MTN) Zimbabwe – Harare, ChitungwizaZambia – Lusaka Malawi – Blantyre, Lilongwe South Africa – Durban, HlabisaUnited States – Philadelphia
Early Generation Efficacy TrialsEarly Generation Efficacy Trials Early Generation Efficacy TrialsEarly Generation Efficacy Trials
Next Generation MicrobicidesNext Generation MicrobicidesNext Generation MicrobicidesNext Generation Microbicides
Based on antiretroviral drugs used to treat HIV• IPM’s microbicide candidates fall in this category• Highly potent and HIV-specific
Delivery mechanism for sustained protection• Once a day or less• Gels, intravaginal rings, vaginal tablets and others
Developed as single drugs and in combination
Trial of tenofovir gel initiated May 2007• South Africa (CAPRISA, CONRAD, USAID)• Coitally dependent
IPM Mission & DonorsIPM Mission & DonorsIPM Mission & DonorsIPM Mission & Donors
Established in 2002 as a non-profit product development partnership (PDP).
IPM’s mission is to prevent HIV transmission by accelerating the development and availability of safe and effective microbicides for use by women in developing countries.
DonorsBelgium, Canada, Denmark, France, Germany, Ireland,
Norway, Netherlands, Sweden, United Kingdom, United States, European Commission, World Bank, UNFPA, Bill & Melinda Gates Foundation, Rockefeller Foundation
Partnerships with IndustryPartnerships with IndustryPartnerships with IndustryPartnerships with Industry
Year Company Compound Type
2004 Tibotec (J&J) Dapivirine (TMC120) NNRTI
2005 Merck M167, M872, M882 CCR5 blockers
2005 Bristol- Myers Squibb BMS793 gp120 binder
2006 Gilead Tenofovir (PMPA gel) NRTI
Year Company Compound Type
2007 Pfizer Maraviroc CCR5 blocker
2007 Schering-Plough Anti-HIV Compounds CCR5 blockers
IPM Licenses with Industry
IPM Material Transfer Agreements with Industry
GMP Manufacture
Applicator Filling LinePennsylvania, US
Research and DevelopmentResearch and DevelopmentResearch and DevelopmentResearch and Development
IPM Clinical Studies of DapivirineIPM Clinical Studies of DapivirineIPM Clinical Studies of DapivirineIPM Clinical Studies of Dapivirine
2004-05
Safety/Feasibility
2007 2008
PK
Safety
PK/Feasibility
Safety
PK
Safety Male tolerance
Studies in Belgium, Kenya, Rwanda, South Africa, Tanzania
2009
2005-06
Efficacy trial
Seroconverter protocol
PK
IPM Site Development in AfricaIPM Site Development in AfricaIPM Site Development in AfricaIPM Site Development in Africa
Advanced stage site development(cohort incidence studies)
Early stage site development (cross-sectional incidence studies)
Why Test Microbicides in Why Test Microbicides in Developing Countries?Developing Countries?
Why Test Microbicides in Why Test Microbicides in Developing Countries?Developing Countries?
Countries in greatest need of new HIV prevention options
Communities with high HIV incidence
Test microbicides in contexts in which they will be used
Clinical and regulatory implications
Building understanding and support
IPM Research Center PartnersIPM Research Center PartnersIPM Research Center PartnersIPM Research Center Partners
AfrimeAfrimesh sh
ResearResearch and ch and CareCare
LadysmitLadysmith h
Hospice Hospice AssociatiAssociati
onon
Stanza Stanza Bopape Bopape
CommunCommunity Trustity Trust
Community engagement
Informed consent process Counseling
Pre- and post-HIV testing Condom education and provision Family planning
Referrals Those who initially screen HIV-
positive Pregnancy Social harms
Treatment Sexually transmitted infections Adverse reactions Antiretrovirals for HIV infections
Ethical Guidelines for Clinical TrialsEthical Guidelines for Clinical TrialsEthical Guidelines for Clinical TrialsEthical Guidelines for Clinical Trials
Product Acceptability StudiesProduct Acceptability StudiesProduct Acceptability StudiesProduct Acceptability Studies
Placebo gel formulations• Market research in Kenya, Zambia, South Africa
(500 volunteers), 2006• Assess women’s preferences• Supported acceptability of a daily product
Placebo vaginal ring• Study launched February 2007 (200 volunteers)• Four sites in South Africa, Tanzania, Kenya• Collect early safety and acceptability data
Vaginal tablet and film: initiated Q4 2007
IPM Access PrinciplesIPM Access Principles IPM Access PrinciplesIPM Access Principles
Availability
Accessibility
Acceptability
Affordability
Sample Access ActivitiesSample Access Activities Sample Access ActivitiesSample Access Activities
Intellectual property agreements
Community mobilisation for trials
Market research
Mapping regulatory pathways
Surveying manufacturing capacity
Modelling introduction scenarios
Assessing health system capacity
Lessons learned from other health technologies
European ActivitiesEuropean ActivitiesEuropean ActivitiesEuropean Activities
Europrise: European Vaccines & Microbicides Initiative Int’l research network of 33 partners from 10 countries Chair of IPM’s SAB is coordinator & IPM Belgium is affiliate member
EMPRO: European Microbicides Project Int’l research network of 25 partners in Europe & Africa IPM has advisory role & is planning a joint Phase IIVR trial
EDCTP: European and Developing Countries Clinical Trials Partnership
Partnership of 14 EU countries, Norway & Switzerland to develop clinical interventions in cooperation with 18 African countries
IPM provides proposal review and expertise and supports bridge funding for sites, as requested
IPM Support of Global IPM Support of Global Development EffortsDevelopment Efforts
IPM Support of Global IPM Support of Global Development EffortsDevelopment Efforts
Improvement in health
Reduction in new HIV infections Increased community education and mobilization Regulatory path for new prevention technologies
Capacity building
Infrastructure and equipment Income and skills generation (jobs and training) Access to medical care and support
Women’s rights
Contribution to MDGsContribution to MDGsContribution to MDGsContribution to MDGs
“Microbicides are a development priority. I can think of no other technology that has the potential to dramatically improve the health of women in developing countries. Moreover, I do not see how we can meet the MDGs without safe and effective microbicides.”
STEPHEN LEWIS, 2005 Former UN Special Envoy for HIV/AIDS in Africa