SAN DIEGO--(BUSINESS WIRE)--Oct. 15, 2009-- 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. The SynCon™ gag and pol plasmids are based on gag and pol antigen sequences derived from sequences which encompass most global HIV viruses.
Inovio recently announced safety and immunogenicity data from a Phase I therapeutic HPV/cervical cancer vaccine trial showing enhanced immune responses at low DNA doses followed by electroporation. These HPV and HIV studies represent Inovio’s first two internal product development programs to reach the clinical trial stage with its combination SynCon™ vaccines and in vivo electroporation delivery devices.
Inovio continues its separate work on a previously awarded $23.5 million HVDDT contract from the NIAID to develop a universal, preventive HIV vaccine, PENNVAX™-GP, with broader global coverage.
About HIV, HVTN, NIAID and NIH
The HIV/AIDS epidemic has already claimed more than 25 million lives and another 40 million people are currently estimated to be living with HIV/AIDS worldwide. (UNAIDS) A safe and effective HIV preventive vaccine is urgently needed and is the best long-term hope to bring the HIV/AIDS epidemic under control. (CDC)
The HIV Vaccine Trials Network (HVTN) is an international collaboration of scientists and educators searching for an effective and safe HIV vaccine. The HVTN's mission is to facilitate the process of testing preventive vaccines against HIV/AIDS. HVTN conducts all phases of clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy. The HVTN is supported by a cooperative agreement with NIAID. More info: www.hvtn.org
NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.
The National Institutes of Health (NIH)—The Nation's Medical Research Agency—includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.
About Inovio Biomedical Corporation
Inovio Biomedical is focused on the design, development, and delivery of a new generation of vaccines, called DNA vaccines, to prevent and treat cancers and infectious diseases. The company’s SynCon™ technology enables the design of DNA-based vaccines capable of protecting against both known and new, unknown strains of pathogens such as influenza. Inovio’s proprietary electroporation-based DNA vaccine delivery technology has been shown by initial human data to safely and significantly increase gene expression and immune responses. Inovio’s clinical programs include HPV/cervical cancer (therapeutic) and HIV vaccines. An IND has been filed for an avian influenza vaccine. Inovio is developing its universal and avian influenza vaccines in collaboration with scientists from the University of Pennsylvania, the National Microbiology Laboratory of the Public Health Agency of Canada, and the NIH’s Vaccine Research Center. Other partners and collaborators include Merck, Tripep, University of Southampton, National Cancer Institute, and HIV Vaccines Trial Network. More information is available at www.inovio.com.
This press release contains certain forward-looking statements relating to, among other things, our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in clinical trials and product development programs, including but not limited to the fact that pre-clinical and clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications, that results from one study may not necessarily be reflected or supported by the results of other similar studies, that results from an animal study may not be indicative of results achievable in human studies, that clinical testing is expensive and can take many years to complete, that the outcome of any clinical trial is uncertain and failure can occur at any time during the clinical trial process, and that our electroporation technology and DNA vaccines may fail to show the desired safety and efficacy traits in clinical trials; the availability of funding; the ability to manufacture vaccine candidates; the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or our collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that we and our collaborators hope to develop; whether our proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity; the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2008, our Form 10-Q for the quarterly period ended June 30, 2009, and other regulatory filings from time to time. There can be no assurance that any product in Inovio’s pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate.