Inovio Pharmaceuticals, Inc. (NYSE Amex: INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today the Phase I clinical study assessing Inovio's PENNVAX™-B DNA vaccine delivered using its proprietary electroporation technology in a preventive setting has fully completed the enrollment of 48 healthy volunteers. The multi-center study is being conducted by Inovio's clinical collaborator, the HIV Vaccine Trials Network (HVTN), at several clinical sites under a protocol designated HVTN-080.
“Enrollment for this trial was completed ahead of schedule, with much anticipation for assessing this new concept for HIV vaccines. We look forward to the results of this DNA vaccine trial with its unique mode of action and novel delivery technology.”
Inovio previously reported data from non-human primates demonstrating up to a 100-fold enhancement in immune responses resulting from the vaccine when delivered via in vivo electroporation compared to syringe injection without electroporation. This HVTN-080 study, which is assessing safety and levels of immune responses in humans, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), an agency of the National Institutes of Health (NIH).
Dr. Spyros Kalams, the principal investigator for the study, who is also the Immunology Director of the Vanderbilt Center for AIDS Research at Vanderbilt University Medical Center, said: "Enrollment for this trial was completed ahead of schedule, with much anticipation for assessing this new concept for HIV vaccines. We look forward to the results of this DNA vaccine trial with its unique mode of action and novel delivery technology."
Dr. J. Joseph Kim, Inovio's president and CEO, said, "We are pleased to collaborate with the NIH and HVTN on a vaccine that holds much promise for limiting HIV infection. We recently announced best-in-class immunogenicity data from our clinical trial for our HPV/cervical cancer DNA vaccine using the same technology platform. We are optimistic that electroporation delivery of PENNVAX™-B vaccine will demonstrate similar levels of safety and immunogenicity."
Inovio expects to release final results from this study in Q2 2011, with interim results potentially being reported by year end of 2010.
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