Navigation Links
Sinovac Reports Positive Preliminary Phase I Clinical Trial Results for EV71 Vaccine in Adult Group
Date:3/10/2011

BEIJING, March 10, 2011 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (Nasdaq: SVA), a leading provider of biopharmaceutical products in China, announced today the unblinding of the Phase I clinical trial results for the adult population for its proprietary inactivated vaccine against human enterovirus 71 (EV71), which causes hand, foot, and mouth disease (HFMD). The preliminary Phase I results for the EV71 vaccine in adults showed a good safety profile and preliminary immunogenicity profile. Sinovac subsequently initiated the inoculations in the young children and infant groups. The results are anticipated to be provided in the coming months.

Sinovac obtained the approval from the China State Food and Drug Administration (SFDA) to commence clinical trials for its EV71 vaccine on December 23, 2010. The Phase I clinical trial was initiated in the Guangxi Province on December 30 2010. The Phase I design is a single center, randomization, double blinded, and placebo controlled study. The Phase I clinical trial is on track to enroll 168 healthy volunteers in three different groups: adults, young children and infants. The study will evaluate the safety and preliminary immunogenicity profile in the different age groups. The Phase I clinical trial is being conducted in the adult group first and followed by the young children group and then the infant group, starting with a lower dosage followed by a higher dosage.

The inoculations with lower and higher dosages in 36 healthy adult volunteers and the safety observation were completed on February 25, 2011.

The unblinding conference for the Phase I clinical data in the adult group was held on the afternoon of March 9, 2011. The data unblinding conference was supervised under the Data Safety and Monitoring Committee (DSMC) and instructed by the experts from the Ministry of Health, China SFDA and China CDC. There is no severe adverse event reported after inoculations, which demonstrated good safety and tolerance profile in adult group.

Dr. Weidong Yin, Chairman and CEO, remarked, "These initial results showed no severe adverse events and demonstrated a positive safety and tolerance profile in the adult population. We were pleased to complete the enrollment, inoculations and safety observation of this first group in just two months and recently commenced administering the EV71 vaccine to the healthy volunteers in the young children and infant groups. We will continue to advance the Phase I trial in the coming months and to provide additional updates on our progress."

About SinovacSinovac 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 the 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), Japanese Encephalitis, animal and human rabies, HIB and epidemic meningitis, chickenpox, mumps and rubella. Its wholly owned subsidiary, Tangshan Yian, is focusing on the research, development, manufacturing and commercialization of animal vaccines and has completed the field trials for an independently developed inactivated animal rabies vaccine, which is anticipated to be launched into market in 2011.

Safe Harbor StatementThis 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 LeeSinovac Biotech Ltd.Tel:  +86-10-8279-9871/9659Fax:  +86-10-6296-6910Email: ir@sinovac.comInvestors:Stephanie Carrington/Amy GlynnThe Ruth GroupTel:  +1-646-536-7017/7023Email: scarrington@theruthgroup.comaglynn@theruthgroup.comMediaJason RandoThe Ruth GroupTel:  +1-646-536-7025Email:  jrando@theruthgroup.com
'/>"/>

SOURCE Sinovac Biotech Ltd.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Sinovac Biotech Submits Clinical Trial Application to SFDA for Pneumococcal Conjugate Vaccine (PCV)
2. Sinovac Provides Preliminary Unaudited Fourth Quarter 2010 Sales Range
3. Sinovacs Stock Exchange Listing Moves to NASDAQ Global Select Market
4. Sinovac Receives SFDA Approval to Commence Clinical Trials for Inactivated Enterovirus Type 71 Vaccine
5. Sinovac Announces Preliminary Unaudited Third Quarter 2010 Sales Range and Revises Full Year 2010 Sales Expectations
6. Sinovac Selected by Beijing CDC to Supply Seasonal Flu Vaccine Anflu(R) to Beijing Citizens
7. Sinovac Receives Drug Registration Certificate from Hong Kong Department of Health for Seasonal Flu Vaccine Anflu(R)
8. Sinovac to Host Conference Call to Report Second Quarter 2010 Financial Results
9. Sinovac Holds 2010 Annual Meeting of Shareholders
10. Sinovac Schedules 2010 Annual Meeting of Shareholders
11. Sinovac Selected by Beijing CDC to Supply Hepatitis A Vaccine Healive(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... FRANCISCO, Calif. , June 24, 2016 /PRNewswire/ ... ), a biopharmaceutical company developing novel therapeutics for ... unmet needs, today announced the closing of its ... of common stock, at the public offering price ... in the offering were offered by GBT. GBT ...
(Date:6/24/2016)... 24, 2016 The Academy of Managed Care ... that would allow biopharmaceutical companies to more easily ... make formulary and coverage decisions, a move that addresses ... medicines. The recommendations address restrictions in the ... the drug label, a prohibition that hinders decision makers ...
(Date:6/24/2016)... -- According to a new market research ... Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, 8mm, ... Purchase (Retail, Non-Retail) - Trends & Global Forecasts to ... for the forecast period of 2016 to 2021. This ... 2021 from USD 1.65 Billion in 2016, growing at ...
Breaking Medicine Technology:
(Date:6/26/2016)... N.J. (PRWEB) , ... June 27, 2016 , ... Quality ... sources, yet in many ways they remain in the eye of the beholder, according ... (EBO), a publication of The American Journal of Managed Care. For the full issue, ...
(Date:6/26/2016)... ... June 26, 2016 , ... Pixel Film Studios Released ProSlice Levels, ... editors can give their videos a whole new perspective by using the title ... Pixel Film Studios. , ProSlice Levels contains over 30 Different presets to choose ...
(Date:6/26/2016)... , ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified personal ... personalized through a fitness app. The fitness app plans to fix the two major problems ... offer a one size fits all type program , They don’t eliminate all ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... issues and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the ... several important health care topics including advance care planning, healthcare costs and patient ...
(Date:6/25/2016)... ... ... temporary closing of Bruton Memorial Library on June 21 due to a possible lice infestation, ... aspect of head lice: the parasite’s ability to live away from a human host, and ... necessary one in the event that lice have simply gotten out of control. , As ...
Breaking Medicine News(10 mins):