Malaria Researchers Hunt for Solutions to Potential Threat of Drug and Insecticide Resistance

November 4th, 2009 Comments Off

NAIROBI, 5 NOVEMBER 2009 – Scientists gathered at the world’s largest malaria conference debated the challenge of malaria drug and insecticide resistance and called on researchers and policymakers to act urgently to contain the problem. The threat of failure of frontline tools for malaria control and treatment—treated bednets, insecticides, and artemisinin combination therapies (ACTs)—could leave millions of people vulnerable to the disease, with little recourse for prevention or effective treatment. This could reverse the massive gains achieved with these tools over the last five years.

Staying one step ahead of the malaria parasite, which constantly evolves to become resistant to malaria drugs, will require a redoubling of efforts to develop new classes of effective medicines. The insecticide research and development pipeline will likewise need to be filled with new active ingredients that malaria-carrying mosquitoes have not yet learned to tolerate.

DRUG RESISTANCE

Artemisinin is the most effective front-line drug against malaria in the world today. It was recommended as first-line therapy by the WHO in 2002 and has saved millions of lives since then. However, resistance to this life-saving drug is emerging. Some studies published in 2008-2009 reported a doubling of the time to clear the parasite from the blood in some malaria patients in the western region of Cambodia. However, efficacy at 28 days was maintained, and the patients were still cured with the ACTs they had been given.

This ‘resistance’, first observed in West Cambodia, has now also been reported in the west of Thailand and in eastern Myanmar. But it has not yet been possible to ascertain if this additional ‘resistance’ is due to the Cambodian strains or to different strains. DHA/PQP (Eurartesim®), a new ACT developed by Sigma Tau and Medicines for Malaria Venture (MMV), and recently submitted to the European Agency EMEA, will also be submitted to the regulatory authorities of Cambodia. The drug could be used for the containment of the strains resistant to artemisinin, if requested by the WHO and the government of Cambodia.

In addition, a new generation of drug combinations is under development that could one day replace ACTs.

INSECTICIDE RESISTANCE

Bednets and indoor spraying are the cornerstones of malaria control, having saved millions of lives, and yet they are entirely dependent on mosquito populations remaining susceptible to insecticides. Bednets are especially vulnerable, as pyrethroids are the only class of insecticides currently available for bednets. If pyrethroid resistance becomes widespread, we lose this vital barrier against infection.

The ramp up of control programs will increase pesticide use, and the spread of resistance to all classes of insecticides could become inevitable. High levels of pyrethroid resistance have already been detected in west and southern Africa, and it appears that this is already having an impact of the effectiveness of bednets.

New insecticides that work in an entirely different way to current classes are therefore urgently needed to ensure that the expansion of control efforts does not result in a total failure of one of the only weapons we have against mosquitoes. The International Vector Control Consortium (IVCC) is working in partnership with the major chemical companies to develop new active ingredients. Their partners are using data mining programs to find development candidates for these new active ingredients within their extensive chemical libraries.

Developing entirely new insecticides takes a great deal of time and hundreds of millions of dollars, but it is crucial that the global community act now to prevent the failure of control programs and avert a new public health catastrophe in the developing world. In the meantime, careful and judicious use of the current insecticides is strongly advised.

ON THE GROUND: Dr. Robert Newman

November 4th, 2009 Comments Off

Dr. Robert Newman, Director of the World Health Organization’s Global Malaria Program, discusses his personal history with MIM and his goals for malaria control.

ON THE GROUND: Dr. Charles Wanga

November 4th, 2009 § 1

Prior to the conference, Dr. Charles Wanga, MIM Communications Officer, discusses his hopes for the event and the need for African leadership in malaria research.

New Tools and Political Commitment are Needed to Eradicate Malaria

November 4th, 2009 Comments Off

Innovation, alongside increased access and operational research for today’s best malaria interventions, provides best hope for eradication

NAIROBI, 4 NOVEMBER 2009 – As the 5th Multilateral Initiative on Malaria (MIM) Pan-African Malaria Conference reached its halfway point on Malaria Elimination/Eradication Day, leading researchers, policy makers and public health professionals focused on the long-term goal of malaria eradication.

Achieving eradication will require an integrated approach with new and existing tools – including drugs, diagnostics, long-lasting insecticide treated nets (LLINs), indoor residual spraying (IRS), other forms of vector control, and ultimately a vaccine. But beyond the tools, it will also require education; training and empowerment of patients, caregivers and health care workers; and political will, community leadership and sustained donor funding for innovation.

POLITICAL WILL

Research presented at MIM has highlighted recent achievements in malaria control, raising hopes that dramatic reductions in the burden of malaria may be closer than once thought. For example, just 5 years ago malaria was the leading cause of death in Rwanda. Now, under the leadership of the Ministry of Health, a comprehensive approach to malaria prevention and treatment has led to a decrease in malaria mortality by 60 percent in just two years. Rwanda and other endemic countries can now focus on further efforts towards eradication.

Despite these gains, stakeholders gathered at MIM agree that eradication will require true commitment from African policymakers, national malaria control program officers, donors and other implementing partners. Partnerships among these groups have led to some of the most effective malaria control advances in recent years, and will be essential for success.

RESEARCH & DEVELOPMENT

Throughout the week, scientists at MIM have discussed groundbreaking research on new malaria interventions that can help the global community reach effective eradication of malaria. With a promising new vaccine now in the pipeline, innovative new drugs in development, and a strong toolkit of existing interventions, eradication appears to be an achievable goal.

However, donors must continue to invest in new tools development to maintain a pipeline of products, such as drugs and insecticides, that can replace existing tools as the malaria parasite and vectors evolve and resistance renders interventions ineffective.

ACCESS

Experts gathered at MIM agree that without a concerted effort to massively scale up and sustain use of today’s best tools and tomorrow’s new ones, eradication will not be possible. High tech, cutting-edge, effective, life-saving interventions are pointless if the global community cannot find ways to guarantee that they get to those who need them most. Malaria interventions must be available, affordable and appropriate for local contexts.

Research released at MIM – for example, an unprecedented study on access to artemisinin-combination therapies (ACTs) – will provide evidence for policy decisions and discussions around international financing mechanisms that would increase access to lifesaving interventions.

ADVOCACY

Despite recent strides in research and implementation, eradication will not be easily attained. Continued political support combined with sufficient and sustained funding will be necessary to ensure protection for millions of vulnerable persons around the world. Building on the foundation of malaria research, pressure must be placed on both endemic and donor governments so that they maintain support for innovative treatment and prevention, and evidence-based implementation and scale-up.

Looking Back: An Oral History of MIM

November 4th, 2009 Comments Off

In this official MIM video, African scientists discuss the history of MIM and how it has impacted their careers and their lives.

Malaria Consortium on RDT Training at the Community Level

November 3rd, 2009 Comments Off

The Malaria Consortium presented the results of a multi-organizational Zambian study on the effectiveness of Rapid Diagnostic Testing (RDT) training programs at the MIM Conference today. The study, conducted over the course of one year in Livingstone, assessed the diagnostic accuracy of community workers’ performance when carrying out malaria RDT s. Results showed consistent accuracy for most participants, indicating that well structured training and job-aid can prove effective in mobilizing community workers to use malaria RDTs safely and accurately.

Read the full news story here: http://www.malariaconsortium.org/news/malaria_consortium_at_mim_2009_-_chw.htm

Malaria Consortium on the Evaluation of ITN Strategies

November 3rd, 2009 Comments Off

The Malaria Consortium reported on the urgent need for a widespread understanding of insecticide treated net (ITN) distribution strategies throughout Africa, highlighting the potential impact that a large-scale, continuous, effective ITN campaign could have on household coverage. The Consortium’s Director of Monitoring and Evaluation, Albert Kilian, reported that large scale campaigns followed by continuous distribution strategies can result in sustained high ITN coverage, though a mixed model distribution strategy is key to the elimination of malaria.

Read the full news story here: http://www.malariaconsortium.org/news/malaria_consortium_at_mim_2009.htm

GSK BLOG: Joe Cohen looks back as RTS,S moves forward

November 3rd, 2009 Comments Off

As GSK’s Joe Cohen presented on the the status of the Phase III trial of RTS,S at a press briefing today at MIM, he reflected on its the vaccine’s past.

More Than Medicine: Looking back as RTS,s moves forward

By Joe Cohen, GSK Vaccines R & D

Looking out at the packed room full of reporters this afternoon, ready to announce the progress we have made with the RTS,S Phase III trial, I could not help but think about the past.  One moment in particular comes to mind.

It was five years ago, in 2004, in a cramped room in Mozambique. The walls were sweating and so were we as we waited for the results of the very first RTS,S safety and efficacy trial in children. What would be revealed during that unblinding could make or break the vaccine. We were literally at the edge of our seats.

Those early results, later published in The Lancet, were proof that this vaccine could work in children.

Fast forward five years to today; this time we were the ones giving the good news. From Nairobi, we told the world that more than 5,000 children had been enrolled in the pivotal efficacy trial in just six months. No one person could have done this alone, and I am so grateful to every member of the RTS,S team, which has evolved and grown over the years. It has been my honor to work with them.

Today represented a turning point of sorts. It felt like I, along with all the scientists who have worked on this vaccine over the past two decades, was passing the baton to Africa. The future of this vaccine is now in the capable hands of Salim and Patricia, the two African Principal Investigators who joined me at the briefing today, and all of the other talented researchers leading the trial across Africa. As we head into the last part of this journey, they will usher RTS,S into the future on the ground.

For years, people have questioned whether this vaccine would ever see the light of day. And doubts still linger. But today we showed the world that our dream can become a reality in just a few short years. Looking into the future of RTS,S, I cannot help but echo the words of Kenya’s most famous son: “Yes We Can.” Indeed we must.

This blog entry was originally posted on GSK’s blog, More than Medicine, and can be accessed at: http://www.morethanmedicine.us.gsk.com/blog/.

MIM Researchers Focus on New Tools for Malaria that Offer Greatest Promise Toward Achieving Eradication

November 3rd, 2009 § 2

New research highlights promising drugs, vaccines, vector control and other tools in the pipeline

NAIROBI, 3 November 2009 — On the second day of the MIM Pan African Malaria Conference, leading malaria researchers and product developers provided new insights into interventions currently under development that could improve malaria control, overcome current resistance and accelerate efforts toward eradication.

While it is critical that the global malaria community improve access to the best existing interventions, new and improved drugs, diagnostics, vaccines and vector control methods remain the world’s best hope for eradication. Promising research discussed at MIM highlights the need for sustained financing of projects in the R&D pipeline even as the global community invests in research, development and delivery of next-generation compounds and products.

NEW DRUGS

New drugs are urgently needed because the old ones are no longer effective against the rapidly evolving malaria parasite. The irrational use of artemisinin-combination therapies (ACT) and the use of artemisinin as a single therapy can result in the malaria parasite developing resistance to arguably the world’s most effective antimalarial. To address this, scientists at MIM disclosed a broad range of new drugs and compound classes in the pipeline, some of which specifically tackle emerging resistance and stopping transmission. With the goal of eradication of malaria in mind, researchers are also focusing on drugs that target malaria parasites other than the deadly falciparum parasite. The hope is to one day develop a simple, affordable one-dose malaria cure.

Meanwhile, through the efforts of organizations including the Medicines for Malaria Venture (MMV) and Drugs for Neglected Diseases initiative (DNDi), and their partners, the number of malaria drugs available continues to increase. The last 2 years have seen the launch of two new WHO-prequalified ACTs and there is hope that three additional combination therapies could be pre-qualified in the immediate future.

NEW TOOLS IN VECTOR CONTROL

A proven arsenal of vector control tools designed to combat malaria-bearing mosquitoes are being scaled up to meet 2010 targets for universal coverage of long-lasting insecticide treated nets (LLINs) and Indoor Residual Spraying (IRS). Scientists agree, however, that research is needed to improve the performance of these tools. Insecticide resistance to the pyrethroid class of insecticides used in both IRS and LLINs, the life-span of LLINs, evaluation methods for delivery of malaria prevention, and the integration of vector control methods are all areas of necessary study. Research on each of these topics is being presented at this year’s conference.

Malaria scientists continue to look forward to improved tools (IRS and LLINs) and new means of addressing malaria burden in endemic countries. These include new classes of insecticides, innovative durable wall linings, insecticide treated plastic sheeting made with pyrethroids and carbamates, and potentially the use of fungi as insecticides. Research in these areas can overcome barriers to successful vector control and effectively preventing malaria transmission.

VACCINES

As discussed at MIM, progress toward developing an effective malaria vaccine has accelerated in recent years. Public health experts generally agree that vaccines are an efficient, cost-effective way to fight infectious disease, yet the malaria vaccine field has traditionally faced significant challenges. These include the technical complexity of developing any vaccine against a parasite, the costs associated with holding clinical trials, and the lack of financial incentives for private-sector developers. Now, however, there are several clinical trials underway of vaccine candidates against the most deadly type of malaria parasite.

Vaccine trials currently underway or recently completed include AMA-1, which is being studied in Mali; MZ2, which is in a Phase 1b clinical trial being conducted by the Albert Schweitzer Institute, in Lambaréné, Gabon; MSP3-LSP, which is in a Phase 2b clinical trial in Bamako, Mali; and RTS,S, which has entered a large-scale Phase 3 trial being conducted by 11 medical research institutions in Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, Tanzania.

Phase III trial of GSK’s malaria vaccine candidate now underway in seven African countries

November 3rd, 2009 Comments Off

During a press briefing earlier today at MIM, pharmaceutical company GlaxoSmithKline and its partners, the PATH Malaria Vaccine Initiative (MVI) and the Bill & Melinda Gates Foundation, announced that Phase III trials of RTS,S, the world’s most advanced malaria vaccine candidate, are currently underway in seven African countries. Thus far, more than 5,000 children have already been enrolled in this trial, which will eventually enroll 16,000 children.

Phase II studies published in the Lancet in 2004 and 2005 demonstrated that the vaccine is capable of reducing clinical episodes of malaria by 35 percent and severe malaria by 49 percent.

The current Phase III trial will evaluate the vaccine’s ability to prevent malaria in two age groups: infants aged 6 to 12 weeks and children aged 5 to 17 months. If these trials are successful, data based on efficacy in children 5-17 months of age could be submitted under the European Medicines Agency (EMEA) Article 58 – a regulatory framework for pharmaceutical product intended exclusively for export – as early as 2012.

Thus far, GSK has invested $300 million in this project and expects to invest an additional $100 million before its completion.  The Bill & Melinda Gates Foundation has also provide the project with more than $200 million of financial support.

For more information, please read GSK and MVI’s joint press release:

http://www.eurekalert.org/pub_releases/2009-11/bc-wlm110209.php