LigoCyte presents Phase I/II study results of NoV vaccine for gastroenteritis at IDSA Meeting

Oct 26 2010

LigoCyte Pharmaceuticals, Inc., a private, clinical-stage biopharmaceuticals company developing innovative vaccine products, today announced positive results from a Phase I/II challenge study of its norovirus virus-like particle (VLP) vaccine candidate. Baylor College of Medicine's Robert Atmar, M.D., the study's principal investigator, shared data from the trial via an oral presentation at the Infectious Diseases Society of America (IDSA) 2010 Annual Meeting on October 23 in Vancouver, British Columbia.

"We are extremely pleased with the opportunity to share the important results from this carefully designed proof-of-concept, multi-center challenge study. Challenge studies are rigorous tests and we have established for the first time that immunized subjects can reduce their risk of norovirus illness by receiving a vaccine," said Donald P. Beeman, Chief Executive Officer. "The study data are very encouraging, indicating statistically significant reductions in clinical norovirus illness, infection, and severity of illness in subjects who received vaccine compared to those who received placebo."

In his presentation, entitled "Efficacy of An Intranasal (IN) Norovirus (NoV) Vaccine to Prevent Acute Gastroenteritis (AGE) Following Experimental Live GI.1 NoV Challenge," Dr. Atmar described the challenge study in which 84 adults completed the challenge after receiving two doses of the vaccine or placebo. The vaccine was generally well tolerated, and demonstrated 47 percent efficacy against any norovirus illness, including mild illness,>

"At LigoCyte, we are focused on developing a vaccine that has the potential to help address the critical unmet medical need resulting from the burden of norovirus illness in both developed and developing countries," added Mr. Beeman.

Additional information on LigoCyte's norovirus vaccine program was presented last week at the Fourth International Conference on Calicivirus Meeting in Santa Cruz, Chile. In addition, a poster by LigoCyte's Chief Scientific Officer Robert Bargatze, Ph.D., has been accepted for presentation at the Keystone Symposia on Immunological Mechanisms of Vaccination to take place next week in Seattle, Washington.