Navigation Links
Sinovac Reports Positive Preliminary Phase II Clinical Trial Results for EV71 Vaccine Against Hand, Foot and Mouth Disease
Date:11/9/2011

BEIJING, Nov. 9, 2011 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, announced today the positive top-line results from its phase II clinical trial for its proprietary inactivated vaccine against human enterovirus 71 (EV71), which causes hand, foot and mouth disease (HFMD).  The preliminary Phase II results for the EV71 vaccine showed a good immunogenicity and a favorable safety profile with no vaccine-related serious adverse event.

The phase II trial was designed as a single center, randomization, double blinded, and placebo controlled study and enrolled 540 healthy volunteers, comprised of infants from six months to thirty-five months old. On November 8, 2011, the unblinding conference for the phase II clinical data was held under the supervision from the Data Safety and Monitoring Committee (DSMC), and was attended by experts from the China State Food and Drug Administration (SFDA) and the China CDC. The phase II clinical results have provided the reference data for phase III clinical trial, including the vaccination schedule and dosage selection, based on which the proper dosage can be selected to enter into the phase III clinical trial. The purpose for the phase III clinical trial is to evaluate the efficacy of protection against HFMD caused by EV71 and is designed as a multi-center, randomized, double-blinded and control study.

Dr. Weidong Yin, Chairman and CEO, remarked, "The positive phase II results are the significant milestone in the development of our EV71 vaccine to address a significant unmet medical need in those area, where the young children are under the high risk of infection. Based on the phase II results, the proper dosage level can be selected to be utilized in the phase III clinical trial. We have started the preparation work for the phase III clinical trial, including determining the phase III clinical trial proposal, selecting the clinical sites and preparing for the vaccines to be used in phase III clinical trial. We anticipate commencing the phase III clinical trial in the coming months, and aim to complete it in one year."

In parallel to the clinical development, Sinovac's engineering team is working on setting up a dedicated manufacturing facility for its EV71 vaccine and aims to complete the construction and GMP Certification in 2013.

About EV71

Enterovirus 71, or EV71, causes Hand, Foot, and Mouth Disease (or HFMD). More than 90% of the reported cases occur in children under five years old. HFMD is a common and usually mild childhood disease.  Since 1997, the number of reported HFMD cases associated with severe neurological symptoms caused by EV71 and fatalities has increased significantly across the Asia-Pacific region. Outbreaks have been reported in Vietnam (2011) Malaysia (1997), Taiwan (1998, 2000 & 2001), mainland China (1998-2008), Australia (1999) and Singapore (2000). No specific treatment for this enterovirus infection and no vaccine are currently available.

HFMD represent a very serious problem in China, some other Asian countries and other areas in recent years given that no vaccine and specific treatment is currently available to protect against this disease. EV71 represents a significant health threat to children as a growing number of HFMD cases have been reported in parts of Asia, including mainland China, Vietnam, Hong Kong, Singapore, South Korea, and Taiwan. According to the Chinese Ministry of Health's data available for the period from January 1 to September 30, 2011, the disease caused 399 deaths in China and over 1.2 million HFMD infection cases during the nine-month period, as reported by health authorities. In 2010, there were over 1.7 million reported EV71 infectious cases with over 800 fatal cases. In August of 2011, over 32,000 HFMD infectious cases were reported in Vietnam with 81 deaths. HFMD is common among infants and children, as most of the recently reported cases have occurred in children under five years of age.

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 including hepatitis A, seasonal influenza, H5N1 (bird flu) pandemic influenza and H1N1 influenza. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, PANFLU.1, and has received orders from the Chinese Central Government pursuit to the government stockpiling program. The Company is developing a number of new vaccine products, including vaccines for pneumococcal conjugate, enterovirus 71 (EV71) (against Hand, Foot & Mouth Disease), pneumococcal polysaccharides, human rabies, HIB, rotavirus and epidemic meningitis, chickenpox and mumps & rubella. Its wholly owned subsidiary, Tangshan Yian, is focusing on the research, development, manufacturing and commercialization of animal vaccines, and has launched its internally developed inactivated rabies vaccine in China.

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.

Helen Yang/Chris Lee
Sinovac Biotech Ltd.
Tel:  +86-10-8279-9871/9659
Fax:  +86-10-6296-6910
Email: ir@sinovac.com

Investors:
Stephanie Carrington/Amy Glynn
The Ruth Group
Tel:  +1-646-536-7017/7023
Email: scarrington@theruthgroup.com
aglynn@theruthgroup.com

Media
Victoria Aguiar
The Ruth Group
Tel:  +1-646-536-7013
Email:  vaguiar@theruthgroup.com


'/>"/>
SOURCE Sinovac Biotech Ltd.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Sinovac Commences Vaccination on Volunteers for Phase II Clinical Trial on Pandemic Influenza H5N1 Vaccine
2. Sinovac Provides Update in Pandemic Influenza Vaccines (H5N1) Phase II Clinical Trials
3. Sinovac Initiates Phase II Volunteer Enrollment for Split Viron Pandemic Influenza (H5N1) Vaccine
4. Sinovac Announces Plan to Launch Offering of Common Shares
5. Sinovac Announces Recent Developments
6. Sinovac Obtains Fifth H1N1 Vaccine Order from Chinese Central Government
7. Sinovac Receives Purchase Order from Shanghai Government to Supply Hepatitis A Vaccine Healive(R)
8. Sinovacs PANFLU.1 (H1N1) Regulatory Approval Expanded to Include Geriatric Population
9. Sinovac Files Shelf Registration Statement
10. Sinovac Named One of Chinas Top 10 Most Competitive Companies Listed Overseas in 2009
11. Sinovacs CEO Weidong Yin Nominated for China Central Televisions Prestigious Economic Man-of-the-Year Award
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... CHAPEL HILL, N.C. , June 24, 2016 ... in healthcare decisions and regulators/payers have placed more ... this new environment, patient support programs in the ... support for patients, medications. Consequently, pharmaceutical companies are ... to ensure they are providing products and services ...
(Date:6/24/2016)... 2016 Research and Markets ... Electronics 2015-2025: Applications, Technologies, Forecasts" report to ... In-Mold Electronics, Smart Skin, Structural Health Monitoring, Composite ... Structural electronics involves electronic and/or electrical components and ... dumb structures such as vehicle bodies or conformally ...
(Date:6/24/2016)... PUNE, India , June 24, 2016 ... "Pen Needles Market by Type (Standard Pen Needles, Safety ... 12mm), Therapy (Insulin, GLP-1, Growth Hormone), Mode of Purchase ... published by MarketsandMarkets, This report studies the market for ... is expected to reach USD 2.81 Billion by 2021 ...
Breaking Medicine Technology:
(Date:6/26/2016)... , ... June 26, 2016 , ... On June 10-11, ... of the 2016 Cereal Festival and World’s Longest Breakfast Table in Battle Creek, MI, ... the city’s history as home to some of the world’s leading providers of cereal ...
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... PawPaws ... a new product that was developed to enhance the health of felines. The formula ... , The two main herbs in the PawPaws Cat Kidney Support Supplement ...
(Date:6/26/2016)... , ... June 26, 2016 , ... ... once they have been diagnosed with endometriosis. These women need a treatment plan ... require a comprehensive approach that can help for preservation of fertility and ultimately ...
(Date:6/25/2016)... , ... June 25, 2016 , ... Austin residents seeking ... American College of Mohs Surgery and to Dr. Russell Peckham for medical and surgical ... effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, ... Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms ... Final Cut Pro X . Simply select a ProHand generator and drag it above ...
Breaking Medicine News(10 mins):