06.02.2006 17:06:00
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The Uganda Virus Research Institute (UVRI), in collaboration with the International AIDS Vaccine Initiative (IAVI) and Targeted Genetics, Launches HIV/AIDS Vaccine Trial in Entebbe, Uganda
The trial will be conducted at the Uganda Virus Research Institute(UVRI) in Entebbe, Uganda with Dr. Pontiano Kaleebu acting as thePrincipal Investigator. Parallel trials are currently underway atthree sites in South Africa. There are also plans to evaluate thevaccine candidate at a fifth site, in Zambia, pending regulatoryapproval.
"We are pleased that Uganda continues to play a leading role inthe testing of promising HIV vaccine candidates," said Dr. PontianoKaleebu. "A vaccine is the world's best hope to end the spread of adisease that infects 14,000 men, women and children worldwide everyday."
"Developing an AIDS vaccine for the regions of the world ingreatest need will take innovative North-South partnerships and asustained scientific effort," said Seth Berkley, M.D., President andCEO of IAVI. "The development of this vaccine candidate demonstratesthe role IAVI plays in bringing together the private sector and publicsectors. Uganda provides an excellent scientific environment for HIVvaccine research and clinical trials, a supportive government, and anenergized and aware public."
The vaccine candidate was developed by Targeted GeneticsCorporation, based in Seattle, Washington, USA. The vaccine is basedon HIV subtype C, the subtype of the virus most prevalent in southernand eastern Africa.
The tgAAC09 vaccine candidate is designed as a preventive vaccine,intended to protect people uninfected with HIV from contracting thedisease. It is designed to elicit two different types of immuneresponses, an antibody response and a cell-mediated response.
"Evaluating tgAAC09 in this region advances the development ofthis promising vaccine candidate and we are pleased to be working inpartnership with IAVI and the Uganda government in our fight againstHIV/AIDS. This is an example of the kind of internationalcollaboration that is critical to an expedited pursuit of an effectivevaccine," said H. Stewart Parker, President and Chief ExecutiveOfficer of Targeted Genetics. "Our HIV/AIDS vaccine developmentprogram is designed to generate robust data in a rapid and rigorousmanner, clearly important in support of the global effort to halt theHIV pandemic."
The study being conducted in Uganda is a small-scale trial. Thetrial should take about 18 months to complete and is designed toenroll a total of 78 volunteers at five sites. Its primary objectiveis to test for safety and to gather preliminary data on the ability ofthe candidate vaccine to stimulate the human immune system to fightHIV infection. It is important to test the vaccine in Africa to see ifit is appropriate for use in this region.
Uganda was home to the first-ever HIV vaccine trial in Africa in1999, which was conducted at the Joint Clinical Research Centre. Sincethat time, Uganda has become an important contributor to HIV vaccineresearch and development in partnership with IAVI and also with theWalter Reed Program and Johns Hopkins University.
About the Vaccine Candidate
The vaccine candidate, tgAAC09, utilizes a recombinantadeno-associated viral vector (rAAV) that was developed with andmanufactured by Targeted Genetics Corporation, based in Seattle,Washington, USA. Under the terms of a public-private collaboration,IAVI is funding development, pre-clinical, and clinical studies totest the vaccine. The Phase II trial follows positive safety datareceived from the Phase I trial conducted over the past two years inBelgium, Germany, and India where volunteers received a lower-doserange.
Targeted Genetics' AAV development process is based on a cell linewhich was designed by Philip R. Johnson, MD., at the Children'sResearch Institute on the campus of Children's Hospital, in Columbus,Ohio, USA. Dr. Johnson is now Chief Scientific Officer at theChildren's Hospital of Philadelphia, Pennsylvania, USA.
About IAVI
The International AIDS Vaccine Initiative (IAVI) is a globalnot-for-profit organization whose mission is to ensure the developmentof safe, effective, accessible, preventive HIV vaccines for usethroughout the world. Founded in 1996 and operational in 23 countries,IAVI and its network of collaborators research and develop vaccinecandidates. IAVI's financial and in-kind supporters include the Bill &Melinda Gates Foundation, the New York Community Trust, theRockefeller Foundation, the Starr Foundation; the Governments of theBasque Country, Canada, Denmark, the European Union, Ireland, theNetherlands, Norway, Sweden, the United Kingdom, and the UnitedStates; multilateral organizations such as the World Bank; corporatedonors including BD (Becton, Dickinson & Co.), Continental Airlines,DHL and Pfizer; leading AIDS charities such as Broadway Cares/EquityFights AIDS, Crusaid, Deutsche AIDS Stiftung, and the Until There's ACure Foundation; and other private donors such as the Haas CharitableTrusts. For more information, see www.iavi.org.
About UVRI
The Uganda Virus Research Institute (UVRI), located in Entebbe,Uganda, was established in 1936 as the Yellow Fever Research Instituteby the Rockefeller Foundation. In 1950, after gaining regionalrecognition it was renamed the East African Virus Research institute(EAVRI). After the collapse of the East African Community in 1977, itbecame a Uganda Government public health research institution and wasrenamed the Uganda Virus Research Institute. The Government of Ugandanow administers and funds the institute through the Uganda NationalHealth Research Organization (UNHRO), which is an umbrella researchbody within the Uganda Ministry of Health.
The mission of the institute is to carry out scientific researchconcerning communicable diseases, especially viral diseases of publichealth importance and to advise the government on strategies forcontrol and prevention. The institute also plays a large role incoordinating and administering virology related clinical trials withinthe county. Most recently the institute has been involved in human HIVvaccine clinical trials. The HIV/AIDS Reference and Quality AssuranceLaboratory (HRL), which is part of the institute plays an importantrole in making public policy recommendations to the Uganda NationalDrug Authority on the access and usage of new drugs and medicaltechnologies. The role of the Uganda National Drug Authority issimilar to that of the FDA in the United States.
The institute was the first to isolate more than 20 newarboviruses, including West Nile Virus, Bwamba Fever, Semliki ForestVirus, Orungo, Kadam, and O'nyong'nyong.
About Targeted Genetics
Targeted Genetics Corporation is a biotechnology company committedto the development and commercialization of innovative targetedmolecular therapies for the prevention and treatment of inflammatoryarthritis, HIV/AIDS and other acquired and inherited diseases withsignificant unmet medical need. We use our considerable knowledge andcapabilities in the development and manufacture of gene deliverytechnologies to advance a diverse product development pipeline. Ourproduct development efforts target inflammatory arthritis, AIDSprophylaxis, congestive heart failure, Huntington's disease andhyperlipidemia. To learn more about Targeted Genetics, visit itswebsite at: www.targetedgenetics.com.
Targeted Genetics' Safe Harbor Statement under the PrivateSecurities Litigation Reform Act of 1995:
This release contains forward-looking statements regardingTargeted Genetics' regulatory filings, research programs, clinicaltrials, product development and potential related to tgAAC09. Thesestatements, involve current expectations, forecasts of future eventsand other statements that are not historical facts. Inaccurateassumptions and known and unknown risks and uncertainties can affectthe accuracy of forward-looking statements. Factors that could affectTargeted Genetics' actual results include, but are not limited to, theability to recruit and enroll suitable trial participants, the timing,nature and results of Targeted Genetics' research and clinical trials,Targeted Genetics' ability to raise capital when needed, TargetedGenetics' ability to obtain and maintain regulatory or institutionalapprovals, and, Targeted Genetics' ability to protect our intellectualproperty, as well as other risk factors described in the sectionentitled "Factors Affecting Our Operating Results, Our Business andOur Stock Price" in Targeted Genetics' Quarterly Report on Form 10-Qfor the quarter ended September 30, 2005. You should not rely undulyon these forward-looking statements, which apply only as of the dateof this release. We undertake no duty to publicly announce or reportrevisions to these statements as new information becomes availablethat may change Targeted Genetics' expectations.
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