Sinovac Attended 3rd WHO Meeting On Evaluation Of Pandemic Influenza Prototype Vaccines In Clinical Trials
Main Category: Bird Flu / Avian FluAlso Included In: Immune System / Vaccines; Clinical Trials / Drug Trials
Article Date: 21 Feb 2007 - 0:00 PDT
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Sinovac Biotech Ltd. (Amex: SVA), a leading provider of biopharmaceutical products in China, today announced that Sinovac attended the 3rd WHO meeting on evaluation of pandemic influenza prototype vaccines in clinical trials. The meeting was held on February 15 - 16, 2007 at the World Health Organization's headquarters in Geneva, Switzerland.
The purpose of the forum was to review the evaluation of pandemic vaccines in clinical trials and to make recommendations on research activities that will contribute to the development of effective pandemic vaccines. In attendance at this global gathering were representatives from government regulatory agencies, pharmaceutical companies and research professionals. Sinovac's scientist reported Phase I clinical trial results on the forum.
Sinovac published its paper of clinical trial results, named "Safety and immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1) vaccine: a phase I randomized controlled trail", an online article for The Lancet on September 7, 2006.
In November 2006, Sinovac filed with the SFDA the application to commence a Phase II trial for Panflu. The application is currently under review by the SFDA and two conferences have been held with experts of SFDA. There will be hundreds of volunteer subjects enrolled in the Phase II clinical trial including children from 12 to 17 years old and elders over 60 years old. Sinovac expects to receive the approval to commence Phase II clinical trial of its pandemic influenza vaccine candidate in the near future.
About Pandemic Influenza Vaccine (H5N1)
The Pandemic influenza vaccine (H5N1) is co-developed by Chinese Centers for Disease Control and Prevention and Sinovac Biotech Ltd. The re-assortant H5N1 virus strain used for the vaccine development is from The National Institute for Biological Standards and Control (NIBSC). On November 22, 2005, State Food and Drug Administration (SFDA) approved Sinovac commence a phase I clinical trial on its proprietary Pandemic Influenza Vaccine (H5N1). And the trial is supported by Ministry of Science and Technology of the People's Republic of China.
About Sinovac
Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacture and commercialization of vaccines that protect against human infectious diseases. Sinovac's vaccines include Healive(TM) (hepatitis A), Bilive(TM) (combined hepatitis A and B) and Anflu(TM) (influenza). Sinovac is currently developing human vaccines against the H5N1 strain of pandemic influenza, Japanese encephalitis and SARS. Additional information about Sinovac is available on its website, http://www.sinovac.com.
Safe Harbor Statement
This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words or phrases such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates" and similar statements. Among other things, the business outlook and quotations from management in this press release contain forward-looking statements. Statements that are not historical facts, including statements about Sinovac's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of important factors could cause actual results to differ materially from those contained in any forward- looking statement. Sinovac does not undertake any obligation to update any forward-looking statement, except as required under applicable law.
Sinovac Biotech Ltd.
http://www.sinovac.com
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