Sinovac Biotech reports positive phase 2 results for EV71 vaccine, prepares for phase 3

by Symptom Advice on November 18, 2011

9th Nov 2011, 2:20 pm by Brad Lemaire

Sinovac Biotech (NASDAQ:SVA) posted Wednesday preliminary phase two trial results for EV71, the biopharmaceutical company’s hand, foot and mouth disease vaccine, which elicited a positive immune response and showed a favourable safety profile.

According to results, the EV71 vaccine showed “good immunogenicity” and a favourable safety profile, with no vaccine-related serious adverse events.

In the phase two trial, about 540 subjects, comprised of infants from six months to thirty-five months old, were enrolled in the placebo-controlled study.

Results have provided reference data for a phase three clinical trial, including a vaccination schedule and proper dosage levels.

The phase three trial will evaluate the efficacy of protection against hand, foot and mouth disease and will be designed as a multi-centre, randomized and controlled study.

Sinovac said it expects to initiate the trial in the coming months and aims to finish the study in one year.

“The positive phase two results are a significant milestone in the development of our EV71 vaccine to address a significant unmet medical need in that area,” chief executive Weidong Yi said in a statement.

“We have started the preparation work for the phase three clinical trial, including determining the phase three clinical trial proposal, selecting the clinical sites and preparing for the vaccines to be used.”

Hand-foot-and-mouth disease is a mild and contagious viral infection. it is characterized by sores in the mouth and a rash on the hands and feet. More than 90 percent of reported cases of hand, foot and mouth disease occur in children under five, the company said in a statement.

Since 1997, the number of reported cases associated with severe neurological symptoms caused by EV71, as well as deaths, has risen across the Asia-Pacific region. Outbreaks have been seen in Vietnam, Malaysia, Taiwan, mainland China, Australia and Singapore.

According to the Chinese Ministry of Health’s data available for the period from January 1 to September 30, 2011, the disease caused 399 deaths in China and roughly 1.2 million were infected in a nine-month period, as reported by health authorities. In August of 2011, over 32,000 infectious cases were reported in Vietnam with 81 deaths.

Currently, there are no specific treatments or vaccines available.

In addition, the company said it is working on setting up a manufacturing site for its EV71 vaccine and aims to finish construction and good manufacturing practices certification in 2013.

The Beijing, China-based company’s shares rose four cents, or 1.70 percent, reaching $2.39 Wednesday on the Nasdaq.

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