Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced the positive top-line results from its phase 2 clinical trial for its proprietary inactivated vaccine against human enterovirus 71 (EV71), which causes hand, foot and mouth disease (HFMD). The preliminary Phase 2 results for the EV71 vaccine showed a good immunogenicity and a favorable safety profile with no vaccine-related serious adverse event.
The phase 2 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 2 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 2 clinical results have provided the reference data for phase 3 clinical trial, including the vaccination schedule and dosage selection, based on which the proper dosage can be selected to enter into the phase 3 clinical trial. The purpose for the phase 3 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 2 results are the significant milestone in the development of our EV71 vaccine to address a significant unmet medical need in thos e area, where the young children are under the high risk of infection. Based on the phase 2results, the proper dosage level can be selected to be utilized in the phase 3 clinical trial. We have started the preparation work for the phase 3 clinical trial, including determining the phase 3 clinical trial proposal, selecting the clinical sites and preparing for the vaccines to be used in phase 3 clinical trial.. We anticipate commencing the phase 3 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.
Date: November 9, 2011
Source: Sinovac Biotech Ltd.