Inviragen announced today the initiation of the first clinical trial of the Company's proprietary Hand, Foot and Mouth Disease (HFMD) investigational vaccine, INV21, a highly purified virus particle preparation designed to protect against HFMD caused by enterovirus 71 (EV71). The study will be conducted in Singapore at the Investigational Medicine Unit at the National University Health System under Inviragen's memorandum of understanding with the Duke-NUS Graduate Medical School. This Phase 1 clinical trial of INV21 will assess the safety of the vaccine as well as immune responses in healthy adult volunteers.
"This first clinical study of INV21 is the result of years of research by Inviragen's scientists, and is an important milestone for our company," commented Dr. Joseph Santangelo, Inviragen's chief operating officer. "INV21 was developed in Singapore by Inviragen and our preclinical studies have demonstrated that this vaccine induces broad, neutralizing antibodies to multiple EV71 isolates. Duke-NUS and their strong ties to the hospital community have sped the advance of INV21 into human clinical testing."
"We are committed to translating basic science into clinical practice with the ultimate goal of bringing vaccines such as INV21 to market for the benefit of people in Singapore and the world," stated the clinical trial principal investigator Dr. Paul Tambyah, associate professor of the Department of Medicine, Yong Loo Lin School of Medicine, National University Singapore and senior consultant, Division of Infectious Diseases at the National University Hospital, Singapore. "HFMD can be severely debilitating for some children with a risk of paralysis and death. It also remains an ongoing public health threat with significant economic impact as it continues to affect young children in Singapore and the region. We are eager to continue to work with Inviragen to advance the development of INV21, as well as other vaccine candidates."
The trial is a placebo controlled randomized clinical study and will enroll healthy adults, aged 21 to 45 years. Each individual will receive two immunizations separated by four weeks and will be monitored for any adverse reactions after each administration. Immune responses to INV21 will be measured one, two and six months after the second immunization.