Award to Aeras Boosts Historic Hunt for New Vaccines against TB, as Drug-Resistant Strains Proliferate

Grant Represents Vital Step in Meeting Urgent Global Need To Fund Worldwide Scientific Efforts to Eliminate Airborne Threat

Rockville, MD, USA | Cape Town, South Africa (March 15, 2012) – Aeras announces today the receipt of a grant by the Bill & Melinda Gates Foundation of up to US $220 million over five years, placing it at the forefront of a global scientific initiative aimed at developing safe, effective vaccines against tuberculosis, a disease that infects two billion people worldwide. One of the world’s largest not-for-profit biotechs, Aeras is developing modern vaccines to combat TB against the backdrop of a significant increase in drug-resistant strains. “We are grateful to the Bill & Melinda Gates Foundation for their continued confidence in Aeras and their support of our efforts to develop vaccines against a disease that costs the global economy billions of dollars annually, and hits hardest in the nations of Africa and Eastern Europe, and the emerging economic powerhouses of Asia,” said Jim Connolly, President and Chief Executive Officer of Aeras. “This infusion of funding must be seen as a global call to action in response to one of the world’s deadliest diseases. It will allow Aeras to expand upon existing partnerships in Europe, Africa, China, and around the world, and to build new partnerships that will accelerate the development of safe and effective vaccines. But the scientific challenges are immense, and the threat is global. Without support for this search for new vaccines from every quarter, we will never eliminate TB as a global health threat.” Globally, the TB vaccine field estimates it will need in excess of US$1 billion over the next five years to support worldwide efforts against a disease so complex it is expected to require more than one vaccine to address geographic variations in the strains, different stages of disease, and a variety of target populations. Aeras estimates US $400-500 million will be needed over the next five years if the organization is to accomplish critical TB vaccine development goals set jointly with global research and development partners. This grant provides approximately half of the estimated cost of meeting 2012-2016 milestone targets, while addressing significant scientific questions that must be answered in order to further successful development of new vaccines. “There is an urgent need for the global community to support the full range of tools to eliminate tuberculosis, but the development of TB vaccines that can prevent men, women and children from developing the disease would be the single greatest advance in the global fight against TB,” said Trevor Mundel, President of the Global Health Program at the Bill & Melinda Gates Foundation. “Aeras’ work will help realize the vision for the Decade of Vaccines, to create a world in which all individuals and communities enjoy lives free from vaccine-preventable diseases, through accelerated efforts from all partners. If donor and endemic countries can join together to show their commitment through funding and collaboration, the innovative research that Aeras and others are making possible could one day have a significant impact on TB, which is gaining in its ability to resist the solutions we have in hand. The foundation thanks Aeras for its commitment to the TB research and development space, helping us realize long-term goals sooner.” Once known as “consumption” for the slow wasting away of the people who died of it, tuberculosis is one of history’s great global killers. It kills 1.4 million people every year, equivalent to the entire population of Munich, Germany or Phoenix, Arizona. One out of every three people globally is thought to be infected by the airborne TB organism, although only a portion will go on to develop the disease. And increasing cases of drug-resistant strains of TB, reported in 80 countries and 8 territories over the past several years, is one of the greatest global threats from TB today. A recent World Health Organization (WHO) study reports the highest-ever recorded levels of multi-drug resistant TB worldwide. The WHO estimates the global economic burden of TB at nearly $12 billion a year, with India and China together accounting for more than half the global economic toll. London has the highest TB rate of any capital city in Western Europe, making it one of the city’s biggest health problems today. And a new World Health Organization/European Union plan to address drug-resistant TB estimates18 percent of the global burden of resistant TB is in the European region. In the United States, just one case of extremely drug-resistant TB is estimated to cost a quarter-million dollars to treat. In the last 12 years, TB vaccine research has made dramatic strides, but it began with a tremendous handicap. Scientists had learned little about the disease since the discovery of a vaccine in 1908 that continues to have limited efficacy. So in 2000, when scientists began in earnest to search for a new vaccine, they did so in the virtual dark. “Until 20 or 30 years ago, the global community thought TB was on the way out, along with other killer infectious diseases like smallpox and polio,” said Tom Evans, Chief Scientific Officer of Aeras. “But this lowering of the guard, and the emergence of drug-resistant strains and the deadly combination of TB and rising HIV infections in Africa, has created what the WHO called ‘fire raging out of control’ in developing countries. The disease should now have our full attention.” In the past decade, the number of TB vaccines in clinical trials has grown from zero to a dozen, six of which have been developed by Aeras or with support from Aeras and its partners. Two of these are currently the most clinically-advanced TB vaccine candidates in the world. Aeras scientists and their colleagues are applying what they’ve learned to rapidly test the best proposals coming out of laboratories around the world, in a drive to identify the most promising prospects for the next generation of vaccines. Today’s grant to Aeras will help advance several vaccine candidates into pivotal large-scale efficacy trials, build a robust and diverse pipeline of innovative, next-generation candidates, and develop and utilize key scientific approaches including challenge models, systems biology, and innovative vaccine designs to strengthen and accelerate TB vaccine development. “Aeras is now at the center of the most promising research across private industry, government, and civil society, with the potential to deliver a vaccine by the end of this decade,” said Aeras’ Jim Connolly. “However, no single organization—including Aeras—can do this alone. We are in this together, and to succeed we will need to work with everyone—more investors, researchers, manufacturers, regulatory agencies, and national leaders.” ### About Aeras Aeras (www.aeras.org) is a non-profit product development organization dedicated to the development of effective TB vaccines and biologics to prevent TB across all age groups in an affordable and sustainable manner. Aeras utilizes its broad capabilities and technologies in collaboration with numerous partners and stakeholders to support the development of vaccines and other biopharmaceuticals to address TB and other significant public health needs of underserved populations. To date, Aeras has invented or supported the development of six TB vaccine candidates, which are undergoing Phase I and Phase II clinical testing in Africa, Asia, Europe and North America. Aeras receives funding from the Bill & Melinda Gates Foundation, other private foundations and various governments. Aeras is based in Rockville, Maryland, USA – where it operates a state-of-the-art manufacturing and laboratory facility – and Cape Town, South Africa.

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This press release is reprinted by Alanna Shaikh out of an obscure sense of guilt. It does not represent the opinions of Alanna Shaikh or any of her employers.

Are Shoes ‘the Next Bed-Nets’?: Announcing Footwork, the International Podoconiosis Initiative

(Brighton and Sussex Medical School, Brighton, England) – Footwork, the newly-formed International Podoconiosis Initiative, brings together private and public partners to advance advocacy for and prevention and treatment of podoconiosis, popularly known as ‘podo’, one of the few readily-preventable and treatable Neglected Tropical Diseases (NTDs). Footwork envisions a world free of podoconiosis in our lifetime.

Podoconiosis is a non-infectious elephantiasis found in highland tropical areas where shoes are frequently not worn and barefoot farmers cultivate in volcanic clay soil, allowing irritant mineral particles to cause damage to the lymphatic system in the legs. Causing the disfigurement, debilitation and ostracism of an estimated 4 million people or more globally, the disease hinders livelihoods, quality of life and development in at least 10tropical countries.

Women farmers affected by podoconiosis in western Ethiopia

“Footwork will help bring a spotlight to this long-overlooked disease,” says Dr. Gail Davey, Footwork’s Executive Director and Reader in Global Health at Brighton and Sussex Medical School as well as the world’s foremost expert on podoconiosis. “Podoconiosis is readily preventable by wearing shoes and treatable through a relatively simple but critical regimen of foot-washing, off-the-shelf ointment or emollients, use of compression bandages and skillfully-applied lower-leg massage to aid lymphatic drainage. Wearing shoes not only helps prevent podoconiosis, but also a wide variety of foot-related afflictions such as wounds, parasitic worms, tetanus, Madura foot, jiggers and snakebite. Footwork will help enable shoes to be thought of as ‘the next bed-nets’.”

Dr. Lorenzo Savioli, Director of the World Health Organization (WHO) Department for Control of Neglected Tropical Diseases comments, “WHO fully supports this laudable initiative. Podoconiosis is a neglected condition that mainly affects marginalized populations. We strongly encourage projects aimed at raising awarenessabout this disease.”

Professor David Molyneux, of the Global Alliance to Eliminate Lymphatic Filariasis adds, “This is the first time that international partners have had a forum through which to begin to address the problem of podoconiosis.”

Footwork aims to achieve its vision of the eradication of ‘podo’ through a strategic combination of advocacy/awareness efforts, new research and data collection, and propagation of control interventions.

A new website has been launched in conjunction with the initiative: www.podo.org, which will serve as a central source of information on the disease as well as treatment, research, and an online community for those actively working with podoconiosis in thefield.

Footwork is led by an international and multidisciplinary Steering Committee of specialists and advocates from Brighton and Sussex MedicalSchool, WHO Department for Control of NTDs, the Global Alliance to Eliminate Lymphatic Filariasis; the Center for Neglected Tropical Diseases, Liverpool School of Tropical Medicine; the Centers for Disease Control and Prevention; the Global Network for NTDs; Children Without Worms; the International Foundation for Dermatology; International Orthodox Christian Charities; Mossy Foot UK; National Human Genome Research Institute at the National Institutes of Health; the Research Foundation for Tropical Disease and the Environment, Buea, Cameroon; the Schistosomiasis Control Initiative at Imperial College, London; the UK Coalition Against NTDs; and TOMS Shoes.

Blake Mycoskie, founder and Chief Shoe Giver of TOMS Shoes said, “Eliminating podoconiosis in our lifetime is a bold and achievable goal. It will take passionate people from across health, research, treatment, advocacy, government and commercial entities working together to apply our talents and resources to speed up the journey to restoring a brighter future for millions of people in need.”

Footwork: the International Podoconiosis Initiative was formed in March 2012 to bring together public and private partners to support prevention and treatment of, and advocacy for, podoconiosis. Its vision is a world free of podoconiosis in our lifetimes. Footwork, found at www.podo.org, is a project of Washington DC-based New Venture Fund, an IRS-registered 501(c)3 charitable organization. The Initiative is hosted by the UK’s Brighton & Sussex Medical School, which serves as an international hub for podoconiosis research.

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This press release is reprinted by Alanna Shaikh out of an obscure sense of guilt. It does not represent the opinions of Alanna Shaikh or any of her employers.

Men Respond More Aggressively Than Women to Stress and it’s All Down to a Single Gene

The pulse quickens, the heart pounds and adrenalin courses through the veins, but in stressful situations is our reaction controlled by our genes, and does it differ between the sexes? Australian scientists, writing in BioEssays, believe the SRY gene, which directs male development, may promote aggression and other traditionally male behavioural traits resulting in the fight-or-flight reaction to stress.

Research has shown how the body reacts to stress by activating the adrenal glands which secrete catecholamine hormones into the bloodstream and trigger the aggressive fight-or-flight response. However, the majority of studies into this process have focused on men and have not considered different responses between the sexes.

“Historically males and females have been under different selection pressures which are reflected by biochemical and behavioural differences between the sexes,” said Dr Joohyung Lee, from the Prince Henry’s Institute in Melbourne. “The aggressive fight-or-flight reaction is more dominant in men, while women predominantly adopt a less aggressive tend-and-befriend response.”

Dr Lee and co-author Professor Vincent Harley, propose that the Y-chromosome gene SRY reveals a genetic underpinning for this difference due to its role in controlling a group of neurotransmitters known as catecholamines. Professor Harley’s earlier research had shown that SRY is a sex-determining gene which directs the prenatal development of the testes, which in turn secrete hormones which masculinise the developing body.

“If the SRY gene is absent the testes do not form and the foetus develops as a female. People long thought that SRY’s only function was to form the testes” said Professor Harley. “Then we found SRY protein in the human brain and with UCLA researchers led by Professor Eric Vilain, showed that the protein controls movement in males via dopamine.”

“Besides the testes, SRY protein is present in a number of vital organs in the male body, including the heart, lungs and brain, indicating it has a role beyond early sex determination,” said Dr Lee. “This suggests SRY exerts male-specific effects in tissues outside the testis, such as regulating cardiovascular function and neural activity, both of which play a vital role in our response to stress.”

The authors propose that SRY may prime organs in the male body to respond to stress through increased release of catecholamine and blood flow to organs, as well as promoting aggression and increased movement which drive fight-or-flight in males. In females oestrogen and the activation of internal opiates, which the body uses to control pain, may prevent aggressive responses.

The role of SRY regulation of catecholamines also suggests the gene may have a role in male-biased disorders such as Parkinson’s disease.

“New evidence indicates that the SRY gene exerts ‘maleness’ by acting directly on the brain and peripheral tissues to regulate movement and blood pressure in males,” concluded Lee. “This research helps uncover the genetic basis to explain what predisposes men and women to certain behavioural phenotypes and neuropsychiatric disorders.”

Full citation:Lee. J, Harley. V, “The male fight-flight response: A result of SRY regulation of catecholamines?” Bioessays, Wiley-Blackwell, March 2012, DOI: 10.1002/bies.201100159

URL Upon publication: http://doi.wiley.com/10.1002/bies.201100159

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This press release is reprinted by Alanna Shaikh out of an obscure sense of guilt. It does not represent the opinions of Alanna Shaikh or any of her employers.