Inovio Pharma (INO) Reports Encouraging Data from PENNVAX-B Phase I
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Inovio Pharmaceuticals, Inc. (AMEX: INO) has achieved strong T cell immune responses in a Phase I clinical study of PENNVAX-B, its product for the treatment of the HIV subtype prevalent in North America and Europe, in HIV-positive subjects. These interim results were presented by Dr. Niranjan Y. Sardesai, Inovio's Chief Operating Officer, at the Vaccine World Summit 2012 in Hyderabad, India in a talk titled, "New Development Paradigms and Vaccine Innovation for Infectious Diseases."
"We are particularly excited by the positive interim results of the HIV-001 study in HIV-positive subjects. This data is a first for DNA vaccines by yielding robust T cell immune responses in people chronically infected with HIV. Even though the HIV viral load of these volunteers was suppressed and brought under control by antiretroviral drugs, their immune systems are not normal and would typically have difficulty generating strong T cell responses to any immune stimulating approach. Coupled with positive data from two earlier trials, Inovio's results demonstrate the potency of our synthetic vaccine technology platform and raises the potential for the development of therapeutic vaccines against HIV and other chronic infections," said Dr. J. Joseph Kim, Inovio's President and CEO. "Together with our HIV prophylactic vaccine programs in collaboration with our partners at DAIDS and HVTN, this HIV therapy trial highlights our commitment to addressing one of the foremost global health issues of our time."
The HIV-001 open label, Phase I study enrolled 12 adult HIV-positive volunteers to assess safety and levels of immune responses generated by Inovio's PENNVAX®-B vaccine delivered with its CELLECTRA® electroporation device. PENNVAX®-B consists of SynCon® immunogens targeting HIV gag, pol, and env proteins from HIV subtype B commonly found in North America and Europe.
Study volunteers were required to be on a highly active antiretroviral therapy (HAART) regimen, have undetectable plasma viral load (<75 copies/mL), and have CD4 T lymphocyte counts above 400 cells/µL with nadirs over 200 cell/µL. Twelve (12) eligible subjects were administered a four dose series (day 0, weeks 4, 8 and 16) of PENNVAX-B containing 3 mg of DNA/dose via intramuscular electroporation.
"We are particularly excited by the positive interim results of the HIV-001 study in HIV-positive subjects. This data is a first for DNA vaccines by yielding robust T cell immune responses in people chronically infected with HIV. Even though the HIV viral load of these volunteers was suppressed and brought under control by antiretroviral drugs, their immune systems are not normal and would typically have difficulty generating strong T cell responses to any immune stimulating approach. Coupled with positive data from two earlier trials, Inovio's results demonstrate the potency of our synthetic vaccine technology platform and raises the potential for the development of therapeutic vaccines against HIV and other chronic infections," said Dr. J. Joseph Kim, Inovio's President and CEO. "Together with our HIV prophylactic vaccine programs in collaboration with our partners at DAIDS and HVTN, this HIV therapy trial highlights our commitment to addressing one of the foremost global health issues of our time."
The HIV-001 open label, Phase I study enrolled 12 adult HIV-positive volunteers to assess safety and levels of immune responses generated by Inovio's PENNVAX®-B vaccine delivered with its CELLECTRA® electroporation device. PENNVAX®-B consists of SynCon® immunogens targeting HIV gag, pol, and env proteins from HIV subtype B commonly found in North America and Europe.
Study volunteers were required to be on a highly active antiretroviral therapy (HAART) regimen, have undetectable plasma viral load (<75 copies/mL), and have CD4 T lymphocyte counts above 400 cells/µL with nadirs over 200 cell/µL. Twelve (12) eligible subjects were administered a four dose series (day 0, weeks 4, 8 and 16) of PENNVAX-B containing 3 mg of DNA/dose via intramuscular electroporation.
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