Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) announced today that the first patients have been treated in a clinical trial evaluating immune responses in elderly adults immunized with Inovio's H1N1 SynCon® universal influenza vaccine. This phase I study will evaluate the ability of Inovio's SynCon® vaccine alone as well as in combination with the 2012 seasonal influenza vaccine to generate: protective levels of immune responses;
antigen-specific antibody immune responses against unmatched influenza strains; and
T-cell immune responses that may be helpful in fighting influenza.
The population most susceptible to influenza, those over 65 years of age, represent about 90% of annual influenza deaths in the US. Older people's immune systems typically mount weaker immune responses to vaccines. There is consequently a need for new vaccine technology able to stimulate a broader immune response that is capable of protecting against influenza strains not specifically matched to the strain(s) represented in the vaccine.
The phase I open label study will take place at the University of Manitoba in Winnipeg, Canada, funded in part by a grant from the Canadian Institute of Health Research. In the trial, 50 healthy elderly patients will be divided into three groups: One group of 20 subjects will receive a 2 dose regimen of Inovio's H1N1 SynCon® flu vaccine delivered using Inovio's proprietary CELLECTRA® intradermal electroporation device; a second group of 20 subjects will receive one dose of Inovio's SynCon® vaccine delivered using electroporation followed by a dose of the 2012 trivalent seasonal flu vaccine 24 weeks later; a third group of 10 subjects will receive a placebo delivered by electroporation followed by a dose of the seasonal flu vaccine 24 weeks later. The study will assess the tolerability, safety, and the immune responses of the different vaccination regimens. See the detailed clinical study protocol.
Dr. Gary P. Kobinger, Chief, Special Pathogens Program, National Microbiology Laboratory, Public Health Agency of Canada, and a principal investigator of his study, said, "There have been limited new vaccine innovations with the potential to better protect the elderly against influenza. We are pleased to conduct this trial to evaluate this potential breakthrough influenza vaccine technology."
Dr. J. Joseph Kim, Inovio's President and CEO, said, "We recently reported protective levels of immune responses against six unmatched strains of influenza in our H5N1 clinical study and expect data in the third quarter from our second influenza study, which includes an H1N1 component and is being tested in a population less vulnerable to influenza. Having achieved best-in-class T-cell responses against other diseases, we will also assess T-cell generation against influenza, which is widely believed to be an important avenue to increasing protection for the highly at-risk 65-plus population."
With the vulnerability of elderly in mind, this clinical study will assess the ability to generally induce stronger antibody responses; provide universal cross-strain protection; and stimulate a part of the immune system not triggered by conventional influenza vaccines, the cellular immune response that generates CD8+ killer T-cells.
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