Clinical Trials Resource Center

Connective Tissue Diseases

March 10, 2014

Sinovac Biotech reported results of phase III trials of Enterovirus 71 (EV71)vaccine for the treatment of foot and mouth disease (HFMD), or herpangina. The phase III clinical trial on 10,077 healthy infants and young children in China (six to 35 months of age) was a randomized, double-blind, placebocontrolled, multicenter trial method. The subjects were randomly assigned in a 1:1 ratio to receive two intramuscular doses of either Sinovac’s EV71 vaccine or placebo, 28 days apart for 12 months. Clinical results showed the efficacy of the vaccine was 94.8% among infants and young children and an anti-EV71 neutralizing antibody titer of 1:16 was associated with protection against EV71 associated HFMD or herpangina. Sinovac’s vaccine also demonstrated a 100% efficacy rate against EV71-associated hospitalization and against HFMD with neurologic complications, the main cause of fatalities. Regulatory approval is pending.

July 8, 2002

Results from a 24-week, open-label extension of a phase I trial indicate that both dose levels (0.2 mg/kg and 1.0 mg/kg) of BioMarin Pharmaceutical's Aryplase continue to be well tolerated by the five subjects who have received treatment for a total of 48 weeks. Aryplase is an enzyme replacement therapy being developed for the treatment of mucopolysaccharidosis VI. In addition to the positive safety results, the 1.0 mg/kg dose continued to produce a greater sustained reduction than the 0.2 mg/kg dose in the excretion of urinary glycosaminoglycans.

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