>>NEEDHAM, Mass.--(BW HealthWire)--Sept. 30, 2002--AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN - News) announced today the results of a Phase II dose-ranging study of its investigational cholera vaccine, Peru-15. The objectives of this study were to evaluate the safety, immunogenicity and dose-response relationship of the vaccine with the aim of optimizing dosage and evaluating a new buffer system prior to undertaking larger-scale clinical studies.
"Based on the results of this trial, we have established that a single, oral dose of 108 cfu produces a significant immune response and was well tolerated in vaccinated individuals," said Alistair Wheeler, MD, Vice President, Medical Affairs of AVANT Immunotherapeutics. "The results also confirm that the new buffer system works well with Peru-15, and the study has generated sufficient data to describe a dose-response relationship for the vaccine. Fourteen days after dosing, seroconversion was seen in 0% of the placebo group and 70%, 86.2% and 96.6% in the 106, 107 and 108 cfu dose groups, respectively. Reported adverse events (diarrhea, abdominal pain, and headache) were mild and were similar in frequency amongst volunteers receiving placebo and those receiving the vaccine."
"We are pleased that the results of this study provide a solid basis for the further clinical development of Peru-15," Dr. Wheeler concluded. He noted that AVANT was developing the experimental cholera vaccine for the travelers' market, and had previously announced a clinical research agreement with the International Vaccine Institute (IVI) to conduct clinical trials of Peru-15 in Bangladesh, where cholera is endemic. These results further bolster AVANT's vaccine programs using cholera as a vector directed at food safety and biodefense.
A previous Phase II, double-blind, placebo-controlled trial of the Peru-15 vaccine had demonstrated the ability of a single, oral dose of 108 cfu to provide 100% protection against moderate and severe diarrhea in subjects who had been challenged with live cholera. However, in that trial, the vaccine was associated with a significantly greater incidence of mild headache. In this new dose-ranging Phase II trial, incidence of headache was not significantly different between the placebo group and the vaccinated groups.
AVANT's Peru-15 cholera vaccine candidate is the most advanced in a portfolio of travelers' vaccines in development at AVANT, aimed at protecting against serious bacterial diseases. In addition to the cholera vaccine, AVANT is developing single-dose oral vaccines to offer rapid protection against Salmonella typhi, the cause of typhoid fever, and three important causes of serious diarrheal disease, Shigella, Campylobacter and enterotoxigenic E. coli. AVANT is also using its oral vaccine technology as a basis for the development of additional vaccines aimed at biodefense needs, including vaccines against anthrax or other organisms that might be used as biowarfare agents.<<
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