Iomai Study Shows Self-Applied Travelers' Diarrhea Vaccine Patch Comparable to Clinician-Applied Vaccine Patch
Tuesday February 12, 8:30 am ET
GAITHERSBURG, Md., Feb. 12 /PRNewswire-FirstCall/ -- Iomai Corporation (Nasdaq: IOMI - News) today announced the interim results of a study that showed that the second dose of the two-dose regimen for its novel, patch-based travelers' diarrhea vaccine yields a robust immune response when self-applied by subjects outside of a clinical setting.
The 160-subject study, part of an extensive Phase 2 program for the vaccine, measured the immune response to the vaccine patch, which is approximately the size and shape of an adhesive bandage. Four groups were evaluated: two groups received both doses of the vaccine from a medical professional and two other groups of volunteers administered the second vaccine patch themselves. All groups had robust responses to the vaccine, and a statistical analysis of immune parameters following vaccination showed no significant differences between treatment groups at any time point.
"These results confirm our belief that the Iomai patch can be effectively used by patients without a health care provider present, removing the need for a second trip to a travel clinic," said Stanley C. Erck, Iomai's president and chief executive officer. "Our research has shown that self-application of the second dose further enhances the market potential of this product."
As with past studies of the vaccine, no serious vaccine-related adverse events were reported.
Iomai is completing its Phase 2 program and plans to conduct a Phase 3 efficacy study during summer of 2009, when the travelers' diarrhea season in Latin America is at its peak. Based on the results of the self-application study, Iomai is evaluating the feasibility of including self-administration of the second vaccine dose in that Phase 3 study. The data also suggests the possibility of self-administration of other Iomai vaccines, such as the needle-free influenza vaccine, which remains a priority for the company.
Last year, the company presented data from a Phase 2 field trial of the travelers' vaccine at the Interscience Conference on Antimicrobial Agents and Chemotherapy that demonstrated people who received the vaccine before traveling to Mexico or Guatemala were significantly less likely to report clinically significant diarrhea. Of the 59 individuals who received the vaccine, only three suffered moderate or severe diarrhea, while 23 of the 111 who received a placebo suffered moderate or severe diarrhea, a 75 percent reduction (p=0.007). One of the 59 volunteers in the vaccine group reported severe diarrhea, compared with 12 of the 111 in the placebo group, an 84 percent reduction (p=0.033).
About Travelers' Diarrhea
This year, approximately 55 million international travelers will visit countries where bacteria that cause travelers' diarrhea are endemic, particularly Africa, Asia and Latin America, and about 20 million of those travelers will develop travelers' diarrhea.
A recently completed market study suggested that there is a large market for an effective travelers' diarrhea vaccine, potentially exceeding $750 million annually. If approved, the Iomai vaccine would be the first vaccine for travelers' diarrhea available in the United States.
surf's up......crikey
