Phase I Trial Will Assess Safety of and Immune Responses to Inovio'sPENNVAX(TM)-B Preventive HIV Vaccine
Oct. 15, 2009 (Business Wire) -- Inovio Biomedical Corporation (NYSE Amex: INO), a leader in DNA vaccine design, development and delivery, and the HIV Vaccine Trials Network (HVTN) announced today the initiation of a phase I clinical study of Inovio’s PENNVAX™-B preventive DNA vaccine delivered using its proprietary electroporation technology. The multi-center study will be conducted at several HVTN clinical sites under a protocol designated HVTN-080.
The study will enroll healthy volunteers to assess the safety of and immune responses to this DNA-based vaccine delivered via in vivo electroporation. 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. PENNVAX™-B is currently in a clinical study, being conducted under the HVTN-070 protocol by the same group of collaborators, to test safety and immunogenicity of the vaccine delivered via intramuscular syringe injection without electroporation. The HVTN-080 follow-on study is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), an NIH agency.
Dr. J. Joseph Kim, Inovio’s president and CEO, said, “We are pleased to collaborate with the NIH and HVTN to test the SynCon™ PENNVAX-B HIV vaccine delivered via electroporation. With our recently announced positive interim immunogenicity data from our clinical trial for our human papillomavirus/cervical cancer DNA vaccine using a similar technology approach, we are optimistic that electroporation delivery of PENNVAX™-B vaccine will demonstrate similar levels of safety and immunogenicity in this trial.”
More information about the HVTN-080 trial can be found at www.clinicaltrials.gov.
About Inovio’s PENNVAX-B™ HIV DNA Vaccine
HIV is characterized by its ability to rapidly mutate and evade the immune system or target-specific biopharmaceuticals. Inovio developed its SynCon™ approach to target multiple variants of the antigenic protein(s) associated with a virus that the body will recognize as foreign and attack. The methodology was designed to create DNA plasmid vaccines representing a broad consensus of antigenic variants that emerge through ongoing mutation.
Inovio’s PENNVAX™-B DNA vaccine targets clade B human immunodeficiency virus, the most common type of HIV in North America and Europe. It is designed to produce and induce an immune response against the env, gag and pol proteins of HIV. Using its SynCon™ approach, Inovio created this DNA vaccine using three plasmids designed to each produce a “consensus” version of one of the three selected antigens, with the potential to provide a broader degree of protection. The SynCon™ env plasmid is based on env antigen sequences derived from clade B HIV.