Nov. 9, 2011
/PRNewswire-Asia/ -- Sinovac Biotech Ltd. (NASDAQ: SVA), a leading provider of biopharmaceutical products in
, 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.
, 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.