Drug Discovery & Development - October 28, 2010
LigoCyte Pharmaceuticals, Inc., a private, clinical-stage biopharmaceuticals company developing innovative vaccine products, announced positive results from a Phase 1/2 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, (p=0.006) and 26 percent efficacy against norovirus infection (p=0.046). In the 77 adults who completed the trial as per its original protocol, vaccination decreased the incidence of AGE due to norovirus from 69.2 percent to 36.8 percent and the incidence of norovirus infection from 82.1 percent to 60.5 percent. The severity of illness was also significantly reduced in those vaccinated within the trial (p=0.011).
“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.
Date: October 25, 2010
Source: LigoCyte Pharmaceuticals, Inc.
“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, (p=0.006) and 26 percent efficacy against norovirus infection (p=0.046). In the 77 adults who completed the trial as per its original protocol, vaccination decreased the incidence of AGE due to norovirus from 69.2 percent to 36.8 percent and the incidence of norovirus infection from 82.1 percent to 60.5 percent. The severity of illness was also significantly reduced in those vaccinated within the trial (p=0.011).
“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.
Date: October 25, 2010
Source: LigoCyte Pharmaceuticals, Inc.
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