Efficacy trials will assess prophylactic and therapeutic indications.

2002 NOV 6 - (NewsRx.com & NewsRx.net) -- Antex Biologics, Inc. (ANX) has announced that two phase II trials for its Helivax vaccine against Helicobacter pylori are scheduled to begin next quarter.

One trial will assess the preventative properties of the vaccine while the other trial will assess the vaccine's therapeutic capabilities. Both trials will be conducted in a randomized open-label manner and will include a total of 80 patients in multiple sites throughout the United States. The Helivax vaccine was developed using the company's patented nutriment signal transduction (NST) technology. The company has patents issued and pending claiming composition of matter and methods of using the vaccine, including for both prophylactic and therapeutic indications in humans.

The phase II trials will focus on mucosal immune responses elicited by the vaccine as correlates of protection and on the vaccine's ability to reduce the H. pylori bioburden in infected subjects. Reducing the level of H. pylori bioburden in infected individuals will be used to evaluate Helivax as a therapeutic vaccine.

Antex has conducted a thorough preclinical evaluation of Helivax, including assessing its prophylactic and therapeutic efficacy in murine infection models. Based on immune cell stimulation patterns, cytokine release profiles and antibody isotype patterns elicited among animals immunized with Helivax, the protection afforded by the vaccine appears to correlate with both Th1 (cellular) and Th2 (humoral) type immune responses. Antex has achieved statistically significant protection against infection in prophylactic models and statistically significant results in therapeutic models.

The company has previously conducted phase I safety and immunogenicity trials with Helivax. The first phase I trial, consisting of 45 patients, assessed the safety and immunogenicity of the vaccine in healthy adults. In a dose-response study, groups of subjects with and without H. pylori infection were immunized with ascending doses of the vaccine. H. pylori-infected individuals were assigned, in a double-blind manner, to receive either three doses of the vaccine or a placebo. The vaccine caused no serious adverse events and generated anticipated immune responses to H. pylori in both uninfected and asymptomatic H. pylori-infected individuals. Vaccination did ...