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Two innovative aids vaccine development partnerships launched

November 26, 1998

 New Scientific and Intellectual Property Approaches Would Benefit Most Severely Affected Nations as International AIDS Vaccine Initiative Invests $9.1 Million in UK-Kenya and US-South Africa Vaccine Research Teams

Crusaid and Elton John AIDS Foundation Join National AIDS Trust
and UK Government in Supporting Initiative

LONDON, November 26, 1998 -- Moving to quicken the pace of AIDS vaccine development and help ensure vaccine access to people throughout the world, the International AIDS Vaccine Initiative (IAVI) launched two innovative international HIV vaccine research and development partnerships and invested US$9.1 million in them.

IAVI said both partnership agreements include unique organizational and intellectual property provisions to help ensure that the fruits of the research are made readily available in the world's most severely afflicted countries, where the need for an AIDS vaccine is greatest. IAVI's initial investment in the vaccine-development efforts represents the two single largest AIDS research awards by a non-governmental organization in history.

Goal: A Preventive AIDS Vaccine for All The World

The Rt. Hon. Clare Short, UK Government Secretary of State for International Development, opened a press conference in London by saying, "During the course of today about 16,000 people will be infected with HIV. A preventive AIDS vaccine must be produced and made available to developing countries. That is why the UK Department for International Development attaches so much importance to this work and has provided support to IAVI."

Seth Berkley, M.D., President of IAVI, said: "Our goal is not only to ensure the development of an AIDS vaccine as soon as possible. Our goal is to make it accessible to anybody in the world who needs it."

Berkley also announced that Crusaid and the Elton John AIDS Foundation are each donating £150,000 toward the vaccine development effort. Crusaid and EJAF thus join IAVI's UK Partner, the National AIDS Trust, and the UK Government in supporting AIDS vaccines as the best long-term solution to the global pandemic. In addition the National AIDS Trust is to contribute £80,000 from its recent grant from The Diana, Princess of Wales Memorial Fund to help launch a joint European AIDS vaccines development project with IAVI based in London.

UK-Kenya Collaboration

The scientific partnerships will be pursuing some of the most exciting new vaccine technologies in the world. Led by Prof. Andrew McMichael, M.D., PH.D, of the Medical Research Council Human Immunology Unit in Oxford University and Dr J.J. Bwayo M.D. of the University of Nairobi, the first of the new scientific partnerships will produce an HIV vaccine that combines two separate vaccine constructs: a naked DNA vaccine, plus a modified vaccinia Ankara (MVA) virus vaccine.

Both vaccines in the Oxford-Nairobi project will be derived from strains of the virus circulating in Kenya. The work builds on a long standing UK Medical Research Council-supported programme of work on the immune response to virus infections.

MVA (a key component of the Oxford-Nairobi vaccine candidate) was developed in Germany by Anton Mayr in the 1970s, and the investigators are working with Impfstoffwerk Dessau-Tornau,GmbH (IDT), a pharmaceutical company in RoBlau, Germany, to produce the MVA-HIVconstruct.

U.S.-South African Collaboration

With collaborators from the University of Capetown, South Africa, the second partnership, led by Robert Olmsted, Ph.D., and Robert Johnston, Ph.D., of AlphaVax Human Vaccines Inc., in Durham, North Carolina, USA, will develop a vaccine based on VEE alphavirus replicon particles. The AlphaVax product will be based on strains from South Africa. Until now, most AIDS vaccine candidates have been produced from HIV strains prevalent in North America and Europe. (Detailed descriptions of the two new scientific approaches and the intellectual property agreements are included on the attached fact sheets.)

Both product development partnerships were recommended for funding by IAVI's blue-ribbon Scientific Advisory Committee, which selected them after reviewing a range of proposals from around the world.

"Most Promising Technologies in the World"

"These are two of the most promising new vaccine technologies in the world," said Jaap Goudsmit, M.D., Ph.D., chairman of the Scientific Advisory Committee and chair of the Department of Human Retrovirology at the University of Amsterdam. "They are also far enough along in the development process that we should be able to test them quickly in humans," he added.

Goudsmit emphasized that IAVI's scientific strategy is to ensure that every promising vaccine design is pursued as quickly as possible. That strategy - of moving multiple vaccine candidates forward in partnership with vaccine producers and developing countries - was outlined in IAVI's Scientific Blueprint for AIDS Vaccine Development, released last June at the 12th World AIDS Conference in Geneva.

Joining Berkley, Goudsmit, Short and members of the vaccine development partnerships were Professor Michael Adler, chairman of the National AIDS Trust, IAVI's long-time partner in the UK; James Deutsch, chief executive of Crusaid; and Robert Key, co-director of the Elton John AIDS Foundation. William Makgoba, M.D., Ph.D. , president-elect of South Africa's Medical Research Council, could not attend the launch but issued a statement of support.

Clare Short Calls for AIDS Vaccine Purchase Fund

The Rt. Hon. Clare Short, Secretary of State for International Development, said: "As the first Government partner of IAVI, we applaud these scientific awards and the public/private partnership they provide. The UK Government is taking a lead to ensure finance for vaccine development within G8 countries, the World Bank, and the international community. To make a vaccine widely available, I am keen to help establish and finance the necessary international mechanisms, including a vaccine purchase fund."

National AIDS Trust continues Princess Diana's support for vaccines campaign

Professor Michael Adler, Chair of the National AIDS Trust said, "As IAVI's UK Partner, the National AIDS Trust warmly welcomes the launch of these pioneering scientific partnerships to find an AIDS vaccine. The UK Government is to be commended for its foresight and boldness in taking an international lead in this campaign. Our late Patron, Diana, Princess of Wales was an early IAVI supporter and the National AIDS Trust is providing £80,000 from its recent grant from The Diana, Princess of Wales Memorial Fund to sponsor a new collaborative project with IAVI that will campaign across Europe to increase support for vaccines development. Finding an AIDS vaccine would be a fitting memorial to Princess Diana's work on AIDS."

James Deutsch of Crusaid: "We Dare Not Delay"

James Deutsch, Chief Executive of Crusaid, said: "Crusaid remains committed to supporting people with HIV in the UK through our Hardship Fund and project grants. But we can no longer ignore the catastrophic AIDS pandemic overseas. The £150,000 we are giving today, made possible by a recent legacy, is a down-payment on our determination to raise vital funds for vaccine development. We dare not delay. If Crusaid's involvement does nothing but accelerate vaccine development by six months, we will have saved over four million lives."

Sir Elton John: "End AIDS For All Time"

Sir Elton John, announcing the Elton John AIDS Foundation's £150,000 contribution to IAVI, said: "I have been assured by the world's leading scientists that, given sufficient funding and political will, a vaccine to end AIDS for all time is a genuine possibility. We hope our contribution will lead others, especially governments, to increase their commitments to this cause."

Tests in Humans to Begin in Less than A Year

Members of the product development partnerships spoke enthusiastically of the new effort.

Dr. McMichael said: "We are grateful for IAVI's support, and for the opportunity it has given us to pursue our research for the benefit of those people at the very highest risk of infection with HIV. The work builds on a lot of basic research that we have carried out, with funding from the Medical Research Council. The support from IAVI will enable us to set up this vital collaboration with Dr. Bwayo and his team and to take our vaccine candidate to Kenya after initial testing in this country. We hope to begin Phase I trials in Oxford next autumn and to move on to trials in Kenya in 2000."

Using Strains of HIV Prevalent in Africa

Dr. Anzala, a senior member of the Nairobi team currently working in Oxford, said: "Until now, virtually all AIDS vaccines have been made from strains circulating in the North. This partnership begins to address the great need for research on African strains of the virus. As a native of Kenya, I have seen countless friends and colleagues, including seven of my medical school classmates, succumb to this terrible virus."

Dr. Johnston said: "We and our collaborators have been working for approximately ten years on the scientific underpinnings of this technology and, for the last five years, on its application to an HIV vaccine, an area of obvious critical need worldwide. We are delighted to have this opportunity to participate in a partnership with IAVI and our South African colleagues to design an HIV vaccine for Southern Africa and to move it into clinical trials."

Dr. Olmsted added: "Selection of the AlphaVax technology for support by IAVI builds on past investment in our platform technology by corporate partners in other disease areas, and serves as further validation of the platform."

Added William Makgoba, M.D., Ph.D., president-elect of South Africa's Medica Research Council:"The HIV epidemic, which is creating a social and an economic crisis in South Africa, poses the single most important factor threatening the African Renaissance. The Medical Research Council of South Africa will work together with IAVI and AlphaVax in the development of suitable and specific vaccines for the people."

Notes to Editors:

IAVI and its Funders: Rockefeller, Sloan, Starr, Gates, UK Government and World Bank

IAVI, a UNAIDS Collaborating Centre, is a scientific organisation founded in 1996 whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world. Lean in structure and catalytic in nature, IAVI's work focuses on three areas: education and advocacy; accelerating scientific progress; and creating a more supportive environment for industrial involvement in HIV vaccine development. IAVI's supporters include the Rockefeller, Alfred P. Sloan, Starr, William H. Gates and Until There's A Cure Foundations, as well as the World Bank, UNAIDS and Fondation Marcel Mérieux. IAVI also receives support from the UK Government, Levi Strauss International, Glaxo Wellcome and generous individuals around the world.

The Department for International Development (DFID) is the British government department responsible for promoting development and the reduction of poverty. The government elected in May 1997 increased its commitment to development by strengthening the department and increasing its budget. The policy of the government was set out in the White Paper on International Development, published in November 1997. The central focus of the policy is a commitment to the internationally agreed target to halve the proportion of people living in extreme poverty by 2015, together with the associated targets including basic health care provision and universal access to primary education by the same date.

DFID seeks to work in partnership with governments which are committed to the international targets and seeks to work with business, civil society and the research community to encourage progress which will help reduce poverty. It also work with multilateral institutions including the World Bank, UN agencies and the European Commission. The bulk of its assistance is concentrated on the poorest countries in Asia and Sub-Saharan Africa.

The National AIDS Trust (NAT) is a leading HIV charity dedicated to improving the UK's prevention efforts and the quality of life of people living with HIV/AIDS. To achieve this mission NAT is spearheading a collaborative programme of research and campaign work to inform and influence key decision-makers in the UK and beyond on a host of public policy issues. Diana, Princess of Wales was a friend of NAT from its founding in 1987 and became its Patron in 1991, remaining its champion until her death last year. As NAT Patron Princess Diana publicly supported the launch of IAVI in June 1996 and again that year endorsed its work and the goals of the vaccines campaign. NAT is contributing £80,000 from its recent grant from The Diana, Princess of Wales Memorial Fund to help sponsor the new NAT/IAVI joint project that will campaign across Europe to increase support for vaccines development.

Crusaid is the national fundraiser for HIV and AIDS in the UK, dedicated for the last twelve years to preventing the spread of HIV and improving the quality of life of those living with the virus. Relying entirely on voluntary donations for support, Crusaid produces more fundraising events each year than any other UK charity. This key work supports Britain's national Hardship Fund, helping more than one in ten people with HIV in the UK to afford basic necessities, and large and small projects throughout Britain providing medical and social care, promoting clinical research and now, the search for an AIDS vaccine.

The Elton John AIDS Foundation is an international, non-profit organisation funding direct patient care services that help to alleviate the physical, mental and emotional hardship for those living with HIV/AIDS, as well as AIDS prevention and education programmes. The charity, with offices in Los Angeles and London, was established in 1993 by Elton John. The foundation was initially formed to look after the needs of people with HIV/AIDS living in North America and the United Kingdom. More recently, the UK office has supported projects in 32 countries worldwide, from Romania, France and Spain within Europe to India, Thailand and Bangladesh in South East Asia and, in Africa, projects in Kenya, Malawi, South Africa, and Uganda.

The Oxford-Nairobi partnership is based on the work in the Medical Research Council Human Immunology Unit, headed by Professor McMichael and the extensive clinical studies on AIDS carried out in Nairobi in Dr Bwayo's department. The two groups have been collaborating already for four years, preparing the way for the vaccine studies in Kenya. The Oxford group have specialised in the nature of the immune response to HIV and have made key discoveries on how the immune system responds to viruses and how HIV can undermine these responses. They have developed a new vaccine approach that offers promise for the control of HIV, and this needs to be tested very carefully in trials, first in people at negligible risk of HIV and then in people at high risk. The trials are difficult to carry out, and absolutely essential to determine whether the vaccine will work or not.

AlphaVax, based in Durham, North Carolina, was established to commercialize the proprietary AlphaVax vector system, an innovative delivery technology. The company's technology represents a major advance in vector technology and creates the opportunity to immunize against diseases not currently preventable with vaccines and to substantially improve existing vaccines. In January 1998, AlphaVax closed a corporate partnership with Wyeth-Lederle Vaccines & Pediatrics, a business unit of the Wyeth Ayerst Laboratories Division of American Home Products Company ("Wyeth-Lederle") to develop vaccines in five major disease areas other than HIV. AlphaVax technology was developed by the Company's founding scientists and others at the University of North Carolina at Chapel Hill (UNC-CH) and the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). The technology is the subject of five issued patents, one allowed patent and two patent applications.