Ksjusha
26.05.2005, 18:00
Chiron's HIV Vaccine Candidate Begins Clinical Trial in United States
Trial Underscores Importance of Public-Private Partnership
Second-Generation Candidate Employs Novel Approach to Virus
EMERYVILLE, Calif., Jan. 15/PRNewswire-FirstCall/-Chiron Corporation (Nasdaq: CHIR) announced today the initiation of a clinical trial in the United States for its HIV vaccine candidate. The trial, the result of a collaboration between the HIV Vaccine Trials Network (HVTN), funded by the National Institute of Allergy and Infectious Diseases (NIAID), and Chiron, is testing a new generation of HIV vaccines that attempt to generate cellular immune response together with broad antibody response that will neutralize the virus. The Phase I study will evaluate the safety and immunogenicity of the vaccine.
" Chiron's vaccine candidate represents a novel approach to HIV vaccine development, and we are proud to contribute to the effort to fight the global HIV emergency, " said John Lambert, president, Chiron Vaccines. " Chiron is applying its unique expertise in the field of HIV to focus on where the company can make a difference. The global AIDS epidemic will continue to require strong public-private partnerships to address this growing threat to world health. "
The vaccine candidate employs a strategy that involves priming the immune response by DNA immunization and then boosting with a novel oligomeric (meaning many copies joined together) engineered envelope protein to enhance the production of broadly neutralizing antibodies. The DNA prime uses a novel delivery system in which the DNA is loaded into microparticles. The Chiron DNA vaccine is the first of its kind to be tested in humans.
The Chiron vaccine is not made from live HIV or from HIV-infected cells and does not contain live or killed HIV. This trial will involve approximately 168 participants and will last for approximately 2 years, with 15 months of active involvement for each participant. The study will be initiated in Nashville, TN, St. Louis, MO, and Seattle, WA, and will be expanded to include other HVTN sites as the trial proceeds.
About Chiron
Chiron Corporation, headquartered in Emeryville, California, is a global pharmaceutical company that leverages a diverse business model to develop and commercialize high-value products that make a difference in people's lives. The company has a strategic focus on cancer and infectious disease. Chiron applies its advanced understanding of the biology of cancer and infectious disease to develop products from its platforms in proteins, small molecules and vaccines. The company commercializes its products through three business units: BioPharmaceuticals, Vaccines and Blood Testing. For more information about Chiron, visit the company's website at www.chiron.com.
About the HIV Vaccine Trials Network
The HIV Vaccine Trials Network, a global partnership that conducts HIV vaccine clinical trials, links 25 sites worldwide, bringing together investigators, clinical trial sites and community representatives in the search for a preventative HIV vaccine. By facilitating the process of safe and ethical HIV vaccine trials, the HVTN strives to speed the development of an HIV vaccine. The HVTN is sponsored and supported by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), within the Department of Health and Human Services. For more information, visit the HVTN website at www.hvtn.org.
This news release contains forward-looking statements about the company's expectations, beliefs, plans, objectives, assumptions or future events or performance, including statements regarding product development initiatives, the success of clinical trials, new product marketing, and future product sales, that involve risks, uncertainties and assumptions and are subject to change. A full discussion of Chiron's operations and financial conditions, including factors that may affect the company's business, operating results and future prospects, is contained in documents the company has filed with the SEC, including the form 10-K for the year ended December 31, 2002 and the form 10-Q for the quarter ended September 30, 2003, and will be contained in all subsequent periodic filings made with the SEC. These documents identify important factors that could cause the company's actual performance to differ from current expectations, including the outcome and timing of clinical trials, regulatory review and approvals, manufacturing capabilities, intellectual property protections and defenses, and marketing effectiveness. In particular, there can be no assurance that Chiron will successfully complete clinical trials of new products, develop and receive approval to market new products, or achieve market acceptance for such new products.
Consistent with SEC Regulation FD, the company does not undertake any obligation to update the forward-looking information we are giving today.
SOURCE Chiron Corporation
Trial Underscores Importance of Public-Private Partnership
Second-Generation Candidate Employs Novel Approach to Virus
EMERYVILLE, Calif., Jan. 15/PRNewswire-FirstCall/-Chiron Corporation (Nasdaq: CHIR) announced today the initiation of a clinical trial in the United States for its HIV vaccine candidate. The trial, the result of a collaboration between the HIV Vaccine Trials Network (HVTN), funded by the National Institute of Allergy and Infectious Diseases (NIAID), and Chiron, is testing a new generation of HIV vaccines that attempt to generate cellular immune response together with broad antibody response that will neutralize the virus. The Phase I study will evaluate the safety and immunogenicity of the vaccine.
" Chiron's vaccine candidate represents a novel approach to HIV vaccine development, and we are proud to contribute to the effort to fight the global HIV emergency, " said John Lambert, president, Chiron Vaccines. " Chiron is applying its unique expertise in the field of HIV to focus on where the company can make a difference. The global AIDS epidemic will continue to require strong public-private partnerships to address this growing threat to world health. "
The vaccine candidate employs a strategy that involves priming the immune response by DNA immunization and then boosting with a novel oligomeric (meaning many copies joined together) engineered envelope protein to enhance the production of broadly neutralizing antibodies. The DNA prime uses a novel delivery system in which the DNA is loaded into microparticles. The Chiron DNA vaccine is the first of its kind to be tested in humans.
The Chiron vaccine is not made from live HIV or from HIV-infected cells and does not contain live or killed HIV. This trial will involve approximately 168 participants and will last for approximately 2 years, with 15 months of active involvement for each participant. The study will be initiated in Nashville, TN, St. Louis, MO, and Seattle, WA, and will be expanded to include other HVTN sites as the trial proceeds.
About Chiron
Chiron Corporation, headquartered in Emeryville, California, is a global pharmaceutical company that leverages a diverse business model to develop and commercialize high-value products that make a difference in people's lives. The company has a strategic focus on cancer and infectious disease. Chiron applies its advanced understanding of the biology of cancer and infectious disease to develop products from its platforms in proteins, small molecules and vaccines. The company commercializes its products through three business units: BioPharmaceuticals, Vaccines and Blood Testing. For more information about Chiron, visit the company's website at www.chiron.com.
About the HIV Vaccine Trials Network
The HIV Vaccine Trials Network, a global partnership that conducts HIV vaccine clinical trials, links 25 sites worldwide, bringing together investigators, clinical trial sites and community representatives in the search for a preventative HIV vaccine. By facilitating the process of safe and ethical HIV vaccine trials, the HVTN strives to speed the development of an HIV vaccine. The HVTN is sponsored and supported by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), within the Department of Health and Human Services. For more information, visit the HVTN website at www.hvtn.org.
This news release contains forward-looking statements about the company's expectations, beliefs, plans, objectives, assumptions or future events or performance, including statements regarding product development initiatives, the success of clinical trials, new product marketing, and future product sales, that involve risks, uncertainties and assumptions and are subject to change. A full discussion of Chiron's operations and financial conditions, including factors that may affect the company's business, operating results and future prospects, is contained in documents the company has filed with the SEC, including the form 10-K for the year ended December 31, 2002 and the form 10-Q for the quarter ended September 30, 2003, and will be contained in all subsequent periodic filings made with the SEC. These documents identify important factors that could cause the company's actual performance to differ from current expectations, including the outcome and timing of clinical trials, regulatory review and approvals, manufacturing capabilities, intellectual property protections and defenses, and marketing effectiveness. In particular, there can be no assurance that Chiron will successfully complete clinical trials of new products, develop and receive approval to market new products, or achieve market acceptance for such new products.
Consistent with SEC Regulation FD, the company does not undertake any obligation to update the forward-looking information we are giving today.
SOURCE Chiron Corporation