Download PDP Press Releases (since November 1, 2012)

UPDATE 46: NOVEMBER 1 TO NOVEMBER 30, 2012
PDP FUNDERS GROUP
Items in blue or purple should be hyperlinked to the full text version; if I have made mistakes
many apologies. If you have any issues that you would like to include in the Update please
send them to Jane Rowley ([email protected]).
FUNDER ANNOUNCEMENTS (SINCE NOVEMBER 1, 2012)
Australia - AUSAID
2 November 2012:
Australian leadership to fight malaria and save lives
Foreign Minister Bob Carr today announced Australia will spend more than $100 million over the next
four years to help reduce deaths and illness from malaria in the Asia-Pacific region.
Senator Carr announced the funding at Malaria2012: Saving Lives in the Asia Pacific conference in
Sydney. …
Australia's funding for malaria includes support for several country and regional programs, including
$14.5 million to address drug resistant malaria control and elimination activities in the Mekong and
over $20 million for malaria programs in Solomon Islands, Vanuatu and Papua New Guinea.
Australia will also provide $10 million for malaria research as the first investment under the aid
program's new Medical Research Strategy.
Senator Carr recently announced the appointment of Mr James Gilling as Australia's Ambassador for
HIV/AIDS, Tuberculosis and Malaria. This appointment reflects Australia's focus on the major health
challenges facing the region.
The World Health Organisation's Defeating Malaria in the Americas, Europe, the Middle East, Asia and
the Pacific Report was also launched at the conference.
US - NIH
28 November 2012:
HIV treatment reduces risk of malaria recurrence in children
A combination of anti-HIV drugs has been found to also reduce the risk of recurrent malaria by nearly
half among HIV-positive children, according to researchers supported by the National Institutes of
Health.
The combination of protease inhibitors lopinavir and ritonavir contributed to an overall reduction of
40 percent in the rate of malaria among a group of HIV-positive infants and children up to 6 years old
in Uganda who were also being treated with anti-malarial drugs. This reduction was in comparison to
malaria incidence among children receiving a drug treatment of one of a class of drugs called nonnucleoside reverse transcriptase inhibitors (NNRTIs).
Protease inhibitors interfere with the reproduction of HIV by blocking the protease enzyme of HIV.
The protease inhibitor combination used in the study did not appear to inhibit an initial bout of
malaria — but reduce the chances of a recurrence of the disease following a successful treatment.
The researchers found that blood levels of anti-malarial drugs were higher in children who had
received the protease inhibitors, which may help explain their effectiveness at preventing malaria's
return. …
Wellcome Trust
12 November 2012:
Candidate vaccine reduces malaria by approximately one-third in African infants
Results from a large-scale clinical trial, published in the ‘New England Journal of Medicine’, have
shown that a new candidate vaccine being developed by GlaxoSmithKline (GSK) can help protect
African infants against malaria.
Infants aged 6-12 weeks who received the candidate vaccine RTS,S had one-third fewer episodes of
clinical malaria - including one-third fewer severe episodes - than infants who received a control
vaccine. In terms of side-effects, reactions to the two vaccines were similar.
The trial was conducted at 11 research centres in seven African countries, including at the KEMRIWellcome Trust Research Programme, one of the Wellcome Trust's Major Overseas Programmes. The
UPDATE 46: NOVEMBER 1 TO NOVEMBER 30, 2012
trial was carried out together with GSK and the PATH Malaria Vaccine Initiative (MVI), with funding
from the Bill & Melinda Gates Foundation to MVI. …
15 November 2012:
Common enzyme deficiency may hinder plans to eradicate malaria
A Wellcome Trust-funded study estimates that around 350 million people living in malaria-endemic
countries are deficient in an enzyme that means they can suffer severe complications from taking
primaquine, a key drug for treating relapsing malaria.
This finding is important because primaquine is recommended in the global action plan to eliminate
malaria and is the only drug to prevent malaria relapse. The study, funded by the Wellcome Trust,
suggests that the benefits of implementing a treatment programme with this drug need to be
weighed against the potential harm to a substantial proportion of the population.
People who have a deficiency in the enzyme glucose-6-phosphate dehydrogenase (G6PD) experience
severe complications in response to treatment with primaquine, caused by the breakdown of their
red blood cells. The deficiency is caused by a mutation in the gene for the enzyme. …
22 November 2012:
Three-year study searches for new biological markers to measure parasite clearance
in Chagas' disease
The Drugs for Neglected Diseases initiative (DNDi) has received a £1.9 million Strategic Translation
Award from the Wellcome Trust to identify new biological markers for the evaluation of treatment
efficacy in Chagas’ disease, a potentially fatal neglected tropical disease. …
The funding from the Wellcome Trust will be used to conduct the first large-scale study involving
treatment of non-human primates (macaques) who were naturally infected with the parasite that
causes Chagas' disease while living in an outdoor environment.
The animals will be treated with three different drug regimens compared with placebo and tested for
clearance of the parasite over a period of 12 months after treatment using a range of blood tests. The
primary goal of the study is to see whether these tests can accurately measure parasitological cure. …
PDP PRESS RELEASES (SINCE NOVEMBER 1, 2012)
DNDi
8 November 2012:
International Medical Conference to Assess Progress and Shortcomings of Global
Health Revolution for Neglected Patients
Meeting the lifesaving needs of people left behind by the global health revolution will be the focus of
a major medical conference in December in New York, held by Doctors Without Borders/Médecins
Sans Frontières (MSF), the Drugs for Neglected Diseases initiative (DNDi), and Mount Sinai School of
Medicine’s Global Health Program.
The symposium, Lives in the Balance: Delivering Medical Innovations for Neglected Patients and
Populations, will bring together some of the top minds in the field of global health. The goal will be to
examine the progress and shortcomings of a decade’s worth of international initiatives aimed at
addressing urgent health needs of the poorest populations in the world. Dr. Anthony S. Fauci, director
of the National Institute of Allergy and Infectious Diseases at the US National Institutes of Health, will
deliver the keynote address at the symposium, which will take place December 13-14, 2012, at Mount
Sinai Hospital in New York City. ….
12 November 2012:
USD 3 Million Awarded to Find Biomarkers for Potential Test of Cure for Chagas
Disease
Today at the 61st Annual Meeting of the American Society of Tropical Medicine and Hygiene
(ASTMH), the Drugs for Neglected Diseases initiative (DNDi) announces a new USD 3 million Strategic
Translation Award from the Wellcome Trust to identify new biological markers for the evaluation of
treatment efficacy in Chagas disease, a potentially fatal neglected tropical disease. ….
The USD 3 million Wellcome Trust Award will fund the first-ever large-scale study involving treatment
UPDATE 46: NOVEMBER 1 TO NOVEMBER 30, 2012
of non-human primates (macaques) naturally infected in their outdoor living environment with the
parasite that causes Chagas disease,Trypanosoma cruzi. The animals will be treated with three drug
regimens versus placebo: benznidazole at optimal dose, benznidazole at suboptimal dose, and
another azole compound with anti-parasite activity. Over a period of 12 months after treatment, the
animals will be examined for clearance of the Chagas parasite through polymerase chain reaction
(PCR) and other blood tests. The primary goal of the study is to see if these blood tests can accurately
measure parasitological cure. …
13 November 2012:
Open Access Initiative Reveals Drug Hits for Deadly Neglected Tropical Diseases
The Drugs for Neglected Diseases initiative (DNDi) and Medicines for Malaria Venture (MMV)
announce today the identification of three chemical series targeting the treatment of deadly
neglected tropical diseases (NTDs), through DNDi’s screening of MMV’s open access Malaria Box. The
resulting DNDi screening data are among the first data generated on the Malaria Box to be released
into the public domain, exemplifying the potential of openly sharing drug development data for
neglected patients.
The open access Malaria Box (mmv.org/malariabox) is an MMV initiative launched in December 2011
to catalyse drug discovery for malaria and neglected diseases. It contains 400 molecules, selected by
experienced medicinal chemists to offer the broadest chemical diversity possible and is available free
of charge. In return, MMV requests that any data gleaned from research on the Malaria Box are
shared in the public domain within two years. To date, more than 100 Malaria Boxes have been
delivered to over 20 countries for research on diseases including malaria, neglected diseases, HIV and
cancer.
DNDi, in partnership with the Laboratory for Microbiology, Parasitology and Hygiene (LMPH),
University of Antwerp, screened all the compounds in the Malaria Box against the parasites
responsible for the three NTDs on which DNDi mainly focuses: sleeping sickness (human African
trypanosomiasis), leishmaniasis (including visceral leishmaniasis, or kala azar, also known as black
fever), and Chagas disease. This initial screen identified two potential drug series for the treatment of
sleeping sickness and one for leishmaniasis. The DNDi screens have yielded valuable information that
will strengthen DNDi’s research pipeline. All the biological data from DNDi’s screen, together with the
existing preliminary data from MMV, are now publicly available on the open-source ChEMBL database
(www.ebi.ac.uk/chembl/malaria).
30 November 2012:
DNDi Applauds Call for Scale-Up of Pediatric HIV Treatment in US PEPFAR Blueprint
for an AIDS-Free Generation
The Drugs for Neglected Diseases initiative (DNDi) welcomed the US President’s Emergency Plan for
AIDS Relief (PEPFAR)’s new ‘PEPFAR Blueprint: Creating an AIDS-Free Generation,’ released by US
Secretary of State Hillary Clinton in advance of World AIDS Day, and its focus on ensuring ambitious
scale-up of treatment and diagnosis for people with HIV/AIDS, including children living with HIV/AIDS.
….
EVI
21 November 2012:
EVI Press Release on the interim results of the recent RTS, S phase III efficacy trial
The European Vaccine Initiative urges continued and sustainable malaria vaccine development efforts
and funding. ….
While these results are comforting, a need still exists for further improvement of the malaria vaccine.
Therefore EVI urges continued and sustainable support for second generation Malaria vaccines. Dr
Odile Leroy, Executive Director of European Vaccine Initiative (EVI) “We have come a long way in
Malaria vaccine development, and the recent results of the RTS,S efficacy trial are a major step in
the development of malaria vaccines. It is unambiguously clear that a highly effective malaria vaccine
is not yet within reach, and can only be attained by sustainable funding and development efforts for
the next decade.” …
UPDATE 46: NOVEMBER 1 TO NOVEMBER 30, 2012
IAVI
29 November 2012:
World AIDS Day Statement 2012
… Vaccine research, in particular, has advanced in leaps and bounds since a trial in Thailand
established for the first time, three years ago, that HIV transmission can be prevented through
vaccination. Researchers have now explored the underlying biology of the modest protection
observed in that trial, laying the groundwork for improvements on the vaccine regimen it assessed.
Indeed, two major trials currently being planned aim to do just that.
Meanwhile, vaccine designers have isolated scores of new broadly neutralizing antibodies against HIV
and extensively explored the mechanisms by which the most potent of them block the virus’s entry
into its target cells. They have also begun to unravel how these relatively rare antibodies arise and are
refined within the body. Armed with this information, researchers are now in the early stages of
designing vaccine candidates and immunization strategies that might elicit just such antibodies in
people. Further, major advances in the development of novel vehicles for the delivery of vaccine
antigens and for stimulating immune responses to those antigens have generated considerable
optimism in the field.
Indeed, leading researchers now believe that, if appropriately deployed, the combination of existing
and emerging HIV prevention tools with new HIV vaccines could not only reverse the tide of the
pandemic but bring it to an end. Even a partially effective vaccine could by itself have a huge impact
on HIV epidemics around the world. Modeling by IAVI and the Futures Institute suggests that a
preventive HIV vaccine of 70 percent efficacy that is distributed to just 40 percent of the population in
low- and middle-income countries could avert almost nine million new infections—about a third—in
the first decade after introduction, assuming current trends in HIV prevention coverage are
maintained.
The realization of all this promise depends on sustained funding for HIV prevention research. Political
will, too, must be sustained to secure the progress already made in the campaign against HIV. We
must remember that any call to bring about the “end of AIDS” will only be fulfilled if HIV prevention
remains high on the list of global health priorities. Scaling up access to proven prevention
interventions, and continuing investment in the development of new tools, including microbicides
and vaccines, must therefore feature prominently in the dialogue about achieving and moving beyond
the Millennium Development Goals. …
MVI
9 November 2012:
RTS,S malaria candidate vaccine reduces malaria by approximately one-third in
African infants
Results from a pivotal, large-scale Phase III trial, published online today in the New England Journal of
Medicine (NEJM), show that the RTS,S malaria vaccine candidate can help protect African infants
against malaria. When compared to immunization with a control vaccine, infants (aged 6-12 weeks at
first vaccination) vaccinated with RTS,S had one-third fewer episodes of both clinical and severe
malaria and had similar reactions to the injection. In this trial, RTS,S demonstrated an acceptable
safety and tolerability profile. …
MMV
13 November 2012:
Open access initiative reveals drug hits for deadly neglected tropical diseases
See press release under DNDi
PATH
12 November 2012:
PATH’s Drug Development program announces positive phase 1 results for its antidiarrheal medication
PATH’s Drug Development program announced today the completion of two phase 1 clinical studies
for iOWH032—its investigational new drug to treat acute secretory diarrhea caused by diseases such
as cholera. The studies evaluated the drug’s safety and tolerability and measured the extent and rate
of its absorption, distribution, metabolism, and excretion, reporting no serious adverse events. Based
UPDATE 46: NOVEMBER 1 TO NOVEMBER 30, 2012
on these outcomes, iOWH032 will proceed into the next phase of clinical trials in Bangladesh in early
2013.
The development of iOWH032 is funded by the Bill & Melinda Gates Foundation. Unlike most
currently available medications, iOWH032 is designed to treat the diarrheal processes directly by
reducing fluid secretion, thus shortening both the duration and severity of the symptoms. If
approved, the drug would be used in conjunction with oral rehydration therapy and encourage wider
adoption of and compliance with treatment. …
14 November 2012:
Revolutionary meningitis vaccine breaks another barrier; first to gain approval to
travel outside cold chain
Signaling a potential breakthrough for immunization programs in resource-poor countries,
researchers today announced at the American Society of Tropical Medicine and Hygiene (ASTMH)
conference that regulatory authorities—after conducting a rigorous review of stability data—will for
the first time allow a vaccine in Africa to be transported and stored for as long as four days without
refrigeration or even an icepack.
The meningitis A vaccine known as MenAfriVac®, created to meet the needs of Africa’s meningitis
belt, can now be kept in a controlled temperature chain (CTC) at temperatures of up to 40°C for up to
four days, a decision that could help increase campaign efficiency and coverage and save funds
normally spent maintaining the challenging cold chain during the “last mile” of vaccine delivery.
The outcome of the review and decisions of the Drugs Controller General of India (DCGI), supported
by a Health Canada analysis and confirmed by the World Health Organization (WHO) Vaccines Prequalification Programme, was revealed during a presentation this afternoon at the ASTMH
conference in Atlanta by Godwin Enwere, MD, medical director for the Meningitis Vaccine Project.
The regulatory approval has the effect of permitting the re-labeling of MenAfriVac®, while ensuring
that the vaccine remains effective and safe throughout its life cycle. …
28 November 2012:
New technology for producing thermostable vaccines.
Bend Research Inc., PATH, and Fraunhofer USA Center for Molecular Biotechnology (FhCMB)
announce the development of a new technology for the production of thermostable vaccines.
Utilizing novel formulation and spray-drying processing methods, the technology has enabled
scientists at Bend Research, PATH, and FhCMB to develop a spray-dried influenza vaccine product
that is stable at 50°C for over 2 months. The technology can also be applied to emerging influenza and
other vaccines. ….
28 November 2012:
PATH names Amie Batson as chief strategy officer
PATH today announced the appointment of Amie Batson to the newly created position of chief
strategy officer. Ms. Batson is currently senior deputy assistant administrator for global health with
the US Agency for International Development (USAID) in Washington, DC. Her 20-year career in global
health includes positions with the World Bank, the World Health Organization, and UNICEF.
Ms. Batson will have responsibility for helping guide PATH’s strategy, strengthening its partnerships
and business relationships in the global health community, and contributing to PATH’s advocacy and
policy priorities. She will join PATH in mid-April 2013 and report to Steve Davis, PATH’s president and
CEO. …
28 November:
PATH announces new cervical cancer test for low-resource countries.
China’s State Food and Drug Administration (SFDA) recently approved QIAGEN’s careHPV™ test for
sale. Developed jointly with PATH, an international, nongovernmental organization, careHPV, which is
produced in China, will be sold in that country by January 2013. The test is likely to become available
in India later in the year, with other countries to follow.
The long awaited announcement means that low-resource countries, which largely have not been
able to mount successful, national cervical cancer screening and treatment programs, soon will have a
new option. CareHPV provides results more rapidly than other DNA tests and is designed especially
for use in clinics that lack reliable clean water or electricity.
CareHPV detects the DNA of 14 different types of the human papillomavirus (HPV) that cause cervical
UPDATE 46: NOVEMBER 1 TO NOVEMBER 30, 2012
cancer. ….
CareHPV works well with samples taken from the cervix by doctors and nurses during pelvic
examinations. It shows nearly the same sensitivity with vaginal samples taken without a pelvic exam.
The PATH studies found that vaginal sampling is an attractive option for many women mainly because
pelvic exams are uncomfortable and may be embarrassing.
Some health care professionals initially were skeptical of vaginal sampling, but they quickly began to
see its potential for dramatically increasing the ability of a clinic to collect and process many samples
in a cost-effective, and rapid, manner. If the new test were used broadly, millions of women could be
screened and those with precancer promptly treated, preventing deadly cervical cancer later in life .
Sabin
5 November 2012:
Clinical Trials for First-Ever Human Hookworm Vaccine Advance
The Sabin Vaccine Institute (Sabin) today announced the start of Part II of its Phase I clinical trial of
the Na-GST-1 vaccine candidate, marking another major milestone in the progress toward developing
a human hookworm vaccine. Part II of the trial commenced in Americaninhas, Brazil, following
successful vaccinations in Part I of the study, which began in Belo Horizonte, Brazil in late 2011.
An independent Safety Monitoring Committee (SMC) recently reviewed results from Part I of the
study and determined that no safety issues had been observed after vaccinating healthy adults who
had never been exposed to hookworm. They concluded that these promising results were sufficient
to allow researchers to proceed to the next stage of the trial, in which hookworm-exposed adults will
receive the vaccine candidate.
Part II of the study is taking place in Americaninhas, a hookworm-endemic region of Brazil. The trial
will enroll 66 healthy, hookworm-exposed adults between the ages of 18 and 45. Each volunteer will
receive three injections over four months. Researchers will then follow each volunteer for 12
additional months, monitoring the vaccine’s safety and analyzing the recipients’ immune responses.
29 November 2012:
Engaging a Rising China through Tropical Disease Elimination
Today, the open-access journal PLoS Neglected Tropical Diseases published an editorial encouraging
new global health partnerships between the United States and China. The article’s author, Dr. Peter
Hotez, argues that relations between the United States and China can be strengthened by a
coordinated effort to support neglected tropical disease (NTD) control programs in countries where
these diseases are still a major public health concern. ….
“A joint Sino-U.S. enterprise around NTD control and elimination could be a powerful and winning
combination,” said Dr. Hotez. “While a long term approach is needed to reduce NTDs in Africa and
elsewhere to levels similar to the United States Sand China, there is an opportunity for our nations to
share programmatic expertise and funds for NTD programs. This is a chance to not only work on a
major global health disparity, but is a way for the United States and China to build their diplomatic
relationships with each other and with endemic countries.” …
RECENTLY RELEASED PDP REPORTS/ BRIEFING PAPERS/ ARTICLES
Articles in Peer Reviewed Journals
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A Phase 3 Trial of RTS,S/AS01 Malaria Vaccine in African Infants. The RTS,S Clinical Trials
Partnership. The New England Journal of Medicine. November 9, 2012DOI:
10.1056/NEJMoa1208394
Engaging a Rising China through Neglected Tropical Diseases. Hotez PJ. Editorial. PLoS Negl Trop
Dis 6(11): e1599. doi:10.1371/journal.pntd.0001599. November 2012.
Identification of Compounds with Anti-Proliferative Activity against Trypanosoma brucei brucei
Strain 427 by a Whole Cell Viability Based HTS Campaign. Sykes ML et al. PLoS NTDs, November
2012, 6(11): e1920. doi:10.1371/journal.pntd.0001920.
In-Hospital Safety in Field Conditions of Nifurtimox Eflornithine Combination Therapy (NECT) for
T. b. gambiense Sleeping Sickness. Schmid C et al. PLoS NTDs, November 2012, 6(11):
e1920.doi:10.1371/journal.pntd.0001920.
Fexinidazole: A Potential New Drug Candidate for Chagas Disease. Bahia MT et al. PLoS NTDs,
UPDATE 46: NOVEMBER 1 TO NOVEMBER 30, 2012
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November 2012, doi:10.1016/S0140-6736(12)61732-2.
Cell Biological Characterization of the Malaria Vaccine Candidate Trophozoite Exported Protein 1.
Kulangara C et al. PLOS one, vol 7, issue 10, e46112
“Proof-Of-Concept” Evaluation of an Automated Sputum Smear Microscopy System for
Tuberculosis Diagnosis. Lewis JJ et al. PLoS ONE 7(11): e50173.
doi:10.1371/journal.pone.0050173
Feasibility of distributing rapid diagnostic tests for Malaria in the retail sector: Evidence from an
implementation study in Uganda. Cohen J et al. PLoS ONE 7(11): e48296.
doi:10.1371/journal.pone.0048296
Private sector drug shops in integrated community case management of malaria, pneumonia,
and diarrhea in children in Uganda. Awor P et al. Am J Trop Med Hyg 2012vol. 87 no. 5 Suppl 9296
Other PDP Publications/ Briefing papers
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OneWorld Health Annual Report 2010-2011. November 2012
TB Alliance Annual Report. November 2012.
Identifying and moving levers of acceptance and uptake of recommended quality-assured
paediatric ACTs for non-complicated malaria. MMV commissioned study. November 2012.
Manual for quantification of malaria commodities. Multi-agency report, led by MSH. November
2012.
RECENTLY RELEASED PDP RELATED REPORTS/ BRIEFING PAPERS/ ARTICLES
Reports/ briefing papers/ books
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Innovative Financing for Global Health R&D. Financial Innovations Lab Report. Milken Institute.
November 2012.
Multi-stakeholder Technical Meeting on Implementation Options Recommended by the WHO
Consultative Expert Working Group on Research & Development (CEWG): Financing and
Coordination. Report of a meeting held in October 2012.
Primer on collaborative approaches to health R&D. Center for Global Health R&D Policy
Assessment. Result for Development Institute. Online Tool. November 2012.
Access to Medicine Index. 2012. Access to Medicine Foundation. November 2012.
UNAIDS World AIDS Day report 2012. UNAIDS. November 2012.
2012 Report on Tuberculosis Research Funding Trends, 2005–2011. TAG and Stop TB
Partnership. November 2012.
Achieving the End: One Year and Counting. AVAC 2012 Report. AVAC. November 2012.
Action Agenda to End AIDS : 1st Quarterly Progress Report. amfAR and AVAC. November 2012.
Rethink HIIV. Edited by Bjorn Lomborg. Cambridge University Press. October 2012.
New Technology Needs for Noncommunicable Diseases: A landscaping study. Nundy S & Han E.
Center for Global Health R&D Policy Assessment. Result for Development Institute. November
2012.
Total Market Initiatives for Reproductive Health. PATH, Abt Associates, Reproductive Health
Supplies Coalition. November 2012
Boosting the Immunization Workforce: Lessons from the Merck Vaccine Network – Africa. FSG.
November 2012.
PDP RELATED NEWS/ ARTICLES (SINCE NOVEMBER 1, 2012)
HIV/AIDS
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3 November: Condoms treated with silver nanoparticles could 'completely
inactivate' HIV, other STDs
5 November: Time magazine ranks OraQuick in-home HIV test among best
inventions of 2012
7 November: Canadian-developed HIV vaccine shows promising results, no adverse
effects
UPDATE 46: NOVEMBER 1 TO NOVEMBER 30, 2012
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Malaria
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Vaccines
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8 November: In Africa, we must do the most good with each pound spent on AidsHIV
14 November: Particle Sciences joins MOTIF project on HIV prevention
19 November: US panel advises HIV tests for everyone ages 15 to 64
19 November: Texas Biomed files for novel HIV vaccine
20 November: UNAIDS reports a more than 50% drop in new HIV infections across
25 countries as countries approach the 1000 day deadline to achieve global AIDS
targets
29 November: Finally, SA announces single pill for HIV
29 November: Clinton reveals 'blueprint' for reaching an 'AIDS-free generation'
30 November: FT Health: Combating AIDS 2012
Beating the placebo in HIV prevention efficacy trials: The role of the minimal efficacy
bound. Dimitrov D et al. Journal of Acquired Immune Deficiency Syndromes. 15
October 2012
Cervicovaginal HIV-1-neutralizing immunoglobulin A detected among HIV-1-exposed
seronegative female partners in HIV-1-discordant couples. Choi R et al. AIDS. 13
November 2012; 26(17):2155-2163.
SAMHD1 restricts HIV-1 infection in resting CD4+ T cells. Baldauf H et al. Nature
Medicine. 7 November 2012; 18:1682-1689.
Intravaginal practices and microbicide acceptability in Papua New Guinea:
Implications for HIV prevention in a moderate-prevalence setting. Vallely A et al.
BioMed Central. 1 November 2012
An assessment of the likely acceptability of vaginal microbicides for HIV prevention
among women in rural Ghana. Abdulai M et al. BMC Women's Health. 1 November
2012
Broad and potent neutralization of HIV-1 by a gp41-specific human antibody. Huang
J et al. Nature. 15 November 2012; 491:406-412.
State of the science of adherence in pre-exposure prophylaxis and microbicide trials.
Muchomba F et al. Journal of Acquired Immune Deficiency Syndromes. 15
November 2012; 61(4):490-498
Safety and efficacy of tenofovir/IQP-0528 combination gels - A dual compartment
microbicide for HIV-1 prevention. Dezzutti C et al. Antiviral Research. 26 November
2012; 96(2):221-225.
Special Supplement on the UNAIDS Report 2012 and modelling HIV/ AIDS
estimates. Sexually Transmitted Infections. December 2012, Volume 88,
Supplement 2. November 26.
In vitro profiling of the vaginal permeation potential of anti-HIV microbicides and
the influence of formulation excipients. Grammen C et al. Antiviral Research. 1
November 2012; 96(2):226-233.
Poly (4-styrenesulfonic acid-co-maleic acid) is an entry inhibitor against both HIV-1
and HSV infections - Potential as a dual functional microbicide. Qiu M et al. Antiviral
Research. 1 November 2012; 96(2):138-147.
Artemisinin-resistant Plasmodium falciparum in Pursat province, western Cambodia:
a parasite clearance rate study. Amaratunga C et al. The Lancet Infectious Diseases,
Volume 12, Issue 11, Pages 851 - 858, November 2012
9 November: New studies shed light on what it cost to vaccinate girls against HPV in
low income countries
27 November: Experimental product could offer faster method of developing new
vaccines
Dengue vaccine development: a 75% solution? Halstead SB. The Lancet, Volume
380, Issue 9853, Pages 1535 - 1536, 3 November 2012
Protective efficacy of the recombinant, live-attenuated, CYD tetravalent dengue
vaccine in Thai schoolchildren: a randomised, controlled phase 2b trial. Sabchareon
A et al. The Lancet, Volume 380, Issue 9853, Pages 1559 - 1567, 3 November 2012
UPDATE 46: NOVEMBER 1 TO NOVEMBER 30, 2012
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Industry
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Gov’ts –
US
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WHO
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Effect of vaccines on bacterial meningitis worldwide. McIntyre PB et al. The Lancet,
Volume 380, Issue 9854, Pages 1703 - 1711, 10 November 2012
Effectiveness of an oral cholera vaccine in Zanzibar: findings from a mass vaccination
campaign and observational cohort study. Khatib AM et al. The Lancet Infectious
Diseases, Volume 12, Issue 11, Pages 837 - 844, November 2012
6 November: Pharmaceutical conference focuses on global health and innovation
27 November: Now Released: The 2012 Access to Medicine Index
28 November: Gates-backed index offers Big Pharmas mixed grades on access and
R&D practices
12 November: NIH vaccine chief Gary Nabel trades dream job for big pharma
13 November: Campaign Spending: What Else Can $2 Billion Buy?
16 November: USAID steps up its science efforts
27 November: WHO members develop plan to fight poor-quality medicines
worldwide
29 November: WHO Members Agree On “Strategic Work Plan” On Health R&D – But
No Convention
15 November: Global Fund names Mark Dybul executive director
15 November: Ins and outs of the Global Fund's management
27 November: Putting neglected tropical diseases under spotlight
Global engagement for health could achieve better results now and after 2015.
Carlsson G & Nordstrom. The Lancet, Volume 380, Issue 9853, Pages 1533 - 1534, 3
November 2012.
UK investments in global infectious disease research 1997—2010: a case study.
Head MG et al. The Lancet Infectious Diseases, Early Online Publication, 8 November
2012
ONGOING CONSULTATIONS
FDA posts draft microbicide guidance for public comment
The U.S. Food and Drug Administration (FDA) is seeking public comment on its newly-posted draft
guidance for industry, entitled "Vaginal Microbicides: Development for the Prevention of HIV
Infection." The purpose of the guidance is to assist sponsors in all phases of microbicide development.
It outlines the types of nonclinical studies and clinical trials recommended throughout the drug
development process to support approval of vaginal microbicides for prevention of human
immunodeficiency virus (HIV). The FDA welcomes comments on this guidance until February 21, 2013.
The guidance document is available at:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm328834.htm
UPCOMING MEETINGS
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December 6 2012: EVI 2012 Rendez-Vous. Heidelberg. Germany.
December 13-14 2012: Lives in the Balance: Delivering Medical Innovations for Neglected
Patients and Populations. New York. USA