Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, today announced it has initiated the phase II clinical trial for its proprietary inactivated vaccine against Hand, Foot and Mouth Disease (HFMD), which is caused by EV71.
More than 90 percent of the reported cases of HFMD are reported in children age five and under. Though the disease is common and generally mild in severity, the company notes that in severe cases, HFMD is associated with neurological symptoms caused by EV71.
In the company’s phase I trial, completed in May 2011, the company’s EV71 vaccine demonstrated good safety and tolerance; preliminary immunogenicity study results show the vaccine as an inducer of good immune responses.
The purpose of the phase II clinical trial is to determine the dosage level through the evaluation of the immunogenicity and the safety level of different dosages of Sinovac’s EV71 vaccine candidate. This data will serve as the reference data for phase III clinical trial.
Dr. Weidong Yin, chairman, president & CEO of Sinovac noted said the company is on schedule to move forward with the phase II clinical trial, which is expected to be complete this year. Sinovac is also focusing on its pipeline of other vaccine candidates.
“We are on track to complete the phase II clinical trial within the next six months and expected to commence the phase III clinical trial before the HFMD outbreak season anticipated in the spring of 2012 to assess the efficacy of the vaccine candidate within the expanded population,” Dr. Yin stated in the press release. “At the same time, our R&D team is advancing other vaccine candidates ongoing as planned. The deep pipeline should drive the future commercialization opportunity as we aim to provide high quality vaccine products to children both in China and around the globe.”
For more information visit www.sinovac.com