AVANT ANNOUNCES START OF PHASE IIb STUDY OF ITS CHOLERA VACCINE
October 16, 2000
NEEDHAM, MA (October 16, 2000): AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) announced today the start of a placebo controlled, double-blind Phase IIb study of its cholera vaccine candidate, Peru-15. The study is being conducted by the National Institutes of Health (NIH) in collaboration with the Walter Reed Army Institute of Research (WRAIR) at the Children’s Hospital in Cincinnati. The Phase IIb trial will test the safety, immunogenicity and protective capacity of the vaccine against a challenge with live virulent cholera.
“We are delighted that the NIH is initiating advanced clinical testing of our single dose, oral cholera vaccine,” said Una S. Ryan, President and Chief Executive Officer of AVANT Immunotherapeutics, Inc. “The development of a safe and effective cholera vaccine is important for protecting both travelers and military personnel from cholera in endemic areas. We see the initiation of this trial as the first step in AVANT’s development of an extensive traveler’s vaccine franchise. AVANT has also conducted initial clinical studies of its single dose, oral typhoid vaccine and has a shigella vaccine in preclinical development.”
Earlier Phase I/II studies of AVANT’s Peru-15 vaccine candidate were conducted in collaboration with clinicians at WRAIR, the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) and The Johns Hopkins University. Results of those previous studies indicated that a single, oral dose of Peru-15 was safe, immunogenic and protective against cholera challenge. |
