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India begins its first preventive AIDS vaccine trial

February 07, 2005

India joins the global search for the best hope to stop the epidemics spread

DELHI, February 7, 2005- Today began Indias first-ever human clinical trial of an investigational vaccine candidate designed to prevent HIV/AIDS. The trial is being conducted by a partnership between the Government of Indiathrough the Indian Council of Medical Research (ICMR) and the National AIDS Control Organization (NACO)and the not-for-profit International AIDS Vaccine Initiative (IAVI).

Announcing the trial, The Union Minister of Health and Family Welfare, Dr. Anbumani Ramadoss, said: ―Developing a vaccine to prevent AIDS is one of the most difficult scientific challenges of our time. It is also one of the most urgent health needs. Perseverance is the way forward, and India has a long-term commitment.

IAVI Board Member and Minister of State, Science and Technology Mr. Kapil Sibal said: ―Vaccine research is so critical that the Health Ministry and the Science and Technology Ministry have joined hands to provide the effort the support it needs.

Dr. N. K. Ganguly, Director General of ICMR, heralded the trial as part of the Indian governments commitment to combat the AIDS epidemic: ―Our country is an emerging global leader in biomedical research. With this first trial, Indian scientists are making an important contribution that will bring the world a step closer to an AIDS vaccine.

Dr. S.Y Quraishi, Director General of NACO said: ―The trial initiation is a great culmination of the tripartite partnership among ICMR, NACO and IAVI. We expect to test other vaccine candidates in the coming years under this partnership.

More than 20 years after HIV/AIDS was identified, new infections are occurring worldwide at the rate of 14,000 every day. Public health experts agree that it is essential to develop a safe and effective vaccine.

Researchers are pursuing multiple vaccine candidates simultaneously because it is not certain which of many possible designs may prove effective.

Dr. Seth Berkley, President and CEO of IAVI, highlighted the need for global partnership: ―The partnership in India is an example of the kind of international collaboration that is critical to the quest for a vaccine. We must work together to mobilize the best science in the fight against the epidemic.

The trial in Pune

The Phase I trial that began today is being conducted at ICMR’s National AIDS Research Institute (NARI) in Pune, outside of Mumbai, and is testing a vaccine candidate named tgAAC09 (recombinant adeno–associated viral vector, rAAV). Targeted Genetics Corp. (NASDAQ:TGEN), a Seattle-based biotechnology company, and Columbus Children’s Research Institute (CCRI) in Ohio designed the vaccine candidate in partnership with IAVI.

The vaccine candidate tgAAC09 is modeled after subtype C of HIV, the subtype that accounts for the most infections worldwide and is prevalent in many developing countries, including India and South Africa.

tgAAC09 is designed so that it cannot cause HIV infection or AIDS; it consists of an artificially made copy of a portion of HIV’s genetic material.

 A Phase I vaccine trial is the first stage of human testing, and the primary purpose is to evaluate safety. The trial will take roughly 15 months to complete and will enroll 30 volunteers, men and women, who are in good health and not infected with HIV.

The trial in India is part of a multi-country Phase I trial of tgAAC09 that is also underway in Europe; researchers in Germany and Belgium are testing the vaccine candidate in partnership with IAVI.

Regulatory approval to test tgAAC09 in India was granted by the Drugs Controller General, the Health Ministry Steering Committee, the Genetic Engineering Approval Committee, the NARI Scientific Committee, the NARI Ethics Committee and the National Ethics Committee. For the trial in Germany and Belgium, approval was obtained from authorities in the countries.

tgAAC09 utilizes a vaccine-making technology called recombinant adeno-associated viral vector (rAAV). This showed encouraging results in animals, protecting some of them from developing AIDS after they became infected with a HIV-like virus. Because what works in animals only provides a guide for what might work in humans, researchers now need to study tgAAC09 in clinical trials.

About ICMR: The Indian Council of Medical Research (ICMR), the apex body in India for the formulation, co-ordination and promotion of biomedical research, having been founded in 1911, is one of the oldest medical research bodies in the world.

The Council’s research priorities coincide with the national health priorities such as control/ management of major infectious diseases, fertility control, maternal and child health, nutritional disorders, containment with safety limits of environmental/ occupational health hazards, major non-communicable diseases like cancer, cardiovascular diseases, blindness, diabetes mellitus, hematological disorders and mental health research; and drug research (including herbal drugs). Research in the field of new biology including immunology, cell and molecular biology, genetics, genomics and biotechnology is being pursued more vigorously. All these efforts aim to reduce the total burden of disease and to promote health and well-being of the population.

Human resource development in biomedical research is promoted by ICMR through its Fellowship programmes, Research Sabbatical, Emeritus Scientist, etc. The Council also recognises excellence in research by awarding prizes to Indian scientists for significant research contributions.

About NACO: National AIDS Control Organization (NACO) is the nodal organisation for formulation of policy and implementation of programmes for prevention and control of HIV/AIDS in India. The overall vision of the National AIDS Control Organization (NACO) is to lead and catalyse an expanded response to the HIV/AIDS epidemic in order to contain the spread of infection, reduce people’s vulnerability to HIV, promote community and family based care to HIV/AIDS cases within an enabling environment without any stigmatization and discrimination, and alleviate the epidemic’s devastating social and economic impact.

The National AIDS Control Programme launched in 1987 established a comprehensive, multisectoral programme for the prevention and control of HIV/AIDS in India to prevent HIV transmission; decrease the morbidity and mortality associated with the HIV infection and minimise the socio-economic impact resulting from the HIV infection. The National AIDS Control programme has been decentralised. State AIDS Societies have been set up in all the States and Union Territories to manage state efforts for HIV/AIDS prevention and control, including management of NGO collaboration.

The activities of the National AIDS Control Organization include information, education, communication (IEC) campaigns and social mobilization; condom promotion, blood safety, control of sexually transmitted infections (STIs).

About IAVI: IAVI (www.iavi.org) is a global not-for-profit organization working to accelerate the development of a vaccine to prevent HIV infection and AIDS. Founded in 1996 and operational in 23 countries, IAVI and its network of collaborators research and develop vaccine candidates. IAVI also advocates for a vaccine to be a global priority and works to assure that a future vaccine will be accessible to all who need it. IAVI’s financial and in-kind supporters include the Bill & Melinda Gates, Rockefeller, Alfred P. Sloan and Starr foundations; the governments of Canada, Denmark, Ireland, the Netherlands, Norway, Sweden, the United Kingdom and the United States; multilateral organizations including the European Union and the World Bank; corporations such as BD (Becton, Dickinson & Co.), Continental Airlines and DHL; leading AIDS charities such as Crusaid, Deutsche AIDS Stiftung, and the Until There’s A Cure Foundation; and other private donors such as the Phoebe W. Haas Charitable Trust B.

About Targeted Genetics: Targeted Genetics Corporation develops gene-based products for preventing and treating acquired and inherited diseases. The Company has three clinical product development programs, targeting cystic fibrosis, AIDS prophylaxis and inflammatory arthritis. The Company also has a promising pipeline of product candidates focused on hemophilia and cancer, and a broad platform of gene delivery technologies for application in nucleic acid-based drug development. For more information about Targeted Genetics, visit its website at www.targetedgenetics.com.