AlaskaDenise
In Memoriam
November 12, 2007 11:42 AM Eastern Time
VGX Pharmaceuticals' SynCon? Pandemic Flu Vaccine Protects Against A Lethal Challenge of Live Virus in Pre-Clinical Animal Models
<!---------- END MULTIMEDIA BOX ----------><!---------- START STORY BODY ---------->BLUE BELL, Pa.--(BUSINESS WIRE)--VGX Pharmaceuticals? SynCon? (Synthetic Consensus) pandemic flu DNA vaccines (VGX-3400) provided protection against a lethal challenge of live H5N1 viruses, according to data presented today by Dr. Ruxandra Draghia-Akli at the MVAF 2007-Modern Vaccines/Adjuvants Formulation Conference in Dublin, Ireland.
Dr. Draghia-Akli, VGX?s Vice President of Research, presented study data showing that ferrets treated with VGX?s rationally constructed SynCon? pandemic flu DNA vaccines were fully protected from illness and subsequent death in a challenge using an unmatched Vietnamese strain of avian flu virus. During the experiments, 100% of the ferrets treated with VGX-3400 survived, while 100% of the control animals died. Ferrets represent the most relevant pre-clinical influenza animal model for humans, and data from previous experiments demonstrate that VGX-3400 also protects mice from the unmatched Vietnamese strain of avian flu virus. All vaccines used were delivered with VGX?s patented CELLECTRA? DNA delivery device. The results of both challenges should strongly support an Investigative New Drug (IND) application for VGX-3400, which the Company expects to file by 2Q 2008.
Dr. Draghia-Akli also showed that vaccination with VGX-3400 generated potent neutralizing antibody and cell-mediated immune responses in four separate animal models - mice, ferrets, pigs, and rhesus monkeys. More specifically, VGX-3400 induced protective levels of hemagglutination inhibition (HAI) titers in 100% of the immunized animals for all 4 models. VGX-3400 also induced significant levels of antigen-specific CD8+ killer T cell responses.
?Our data further demonstrates the potential of our DNA vaccine and delivery approaches in addressing a significant global health problem,? stated Dr. J. Joseph Kim, President and CEO of VGX. ?VGX-3400 is just the first step in executing our strategy for developing a universal flu vaccine.?
VGX Pharmaceuticals? SynCon? DNA vaccine antigens are designed by aligning numerous primary sequences and choosing the most common amino acid or base pair at each site by using high-powered and patented bioinformatics approaches. The SynCon? DNA vaccines in combination with the CELLECTRA? delivery device provide greater levels of cross-reactive immune responses than those produced by more traditional vaccines.
Over the years, VGX Pharmaceuticals has also established itself as a leading manufacturer of cGMP-grade DNA plasmids. Most recently, the Company expanded its cGMP manufacturing facility in The Woodlands, Texas to a 500-liter scale and initiated a project to build and operate a 3000-liter cGMP manufacturing facility in Korea with its affiliate, VGX International.
VGX Pharmaceuticals has already initiated IND-enabling pre-clinical toxicology studies for VGX-3400 and two other DNA plasmid-based product candidates: a vaccine for human papilloma virus for the treatment of cervical cancer (VGX-3100) and a therapeutic based on human growth hormone releasing hormone (VGX-3200) for cancer-related cachexia. The Company expects to complete the toxicology studies and to file the INDs for all three products in 2008.
About VGX Pharmaceuticals
VGX Pharmaceuticals is a biopharmaceutical company with small molecule and biologic product candidates for the treatment of infectious diseases, cancer, and inflammatory diseases. The Company's clinical development programs include PICTOVIR? for HIV infection and VGX-410C for chronic HCV infection, both of which are currently in Phase II clinical trials. In addition, VGX is planning to initiate Phase I clinical studies for VGX-1027, its lead compound for inflammatory diseases. VGX's research pipeline includes a new generation of DNA vaccines and therapeutics as well as CELLECTRA? electroporator, a patented DNA delivery device. The product candidates and technology programs are protected by the Company's extensive global intellectual property portfolio. More information about VGX can be found at www.vgxp.com.
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VGX Pharmaceuticals' SynCon? Pandemic Flu Vaccine Protects Against A Lethal Challenge of Live Virus in Pre-Clinical Animal Models
<!---------- END MULTIMEDIA BOX ----------><!---------- START STORY BODY ---------->BLUE BELL, Pa.--(BUSINESS WIRE)--VGX Pharmaceuticals? SynCon? (Synthetic Consensus) pandemic flu DNA vaccines (VGX-3400) provided protection against a lethal challenge of live H5N1 viruses, according to data presented today by Dr. Ruxandra Draghia-Akli at the MVAF 2007-Modern Vaccines/Adjuvants Formulation Conference in Dublin, Ireland.
Dr. Draghia-Akli, VGX?s Vice President of Research, presented study data showing that ferrets treated with VGX?s rationally constructed SynCon? pandemic flu DNA vaccines were fully protected from illness and subsequent death in a challenge using an unmatched Vietnamese strain of avian flu virus. During the experiments, 100% of the ferrets treated with VGX-3400 survived, while 100% of the control animals died. Ferrets represent the most relevant pre-clinical influenza animal model for humans, and data from previous experiments demonstrate that VGX-3400 also protects mice from the unmatched Vietnamese strain of avian flu virus. All vaccines used were delivered with VGX?s patented CELLECTRA? DNA delivery device. The results of both challenges should strongly support an Investigative New Drug (IND) application for VGX-3400, which the Company expects to file by 2Q 2008.
Dr. Draghia-Akli also showed that vaccination with VGX-3400 generated potent neutralizing antibody and cell-mediated immune responses in four separate animal models - mice, ferrets, pigs, and rhesus monkeys. More specifically, VGX-3400 induced protective levels of hemagglutination inhibition (HAI) titers in 100% of the immunized animals for all 4 models. VGX-3400 also induced significant levels of antigen-specific CD8+ killer T cell responses.
?Our data further demonstrates the potential of our DNA vaccine and delivery approaches in addressing a significant global health problem,? stated Dr. J. Joseph Kim, President and CEO of VGX. ?VGX-3400 is just the first step in executing our strategy for developing a universal flu vaccine.?
VGX Pharmaceuticals? SynCon? DNA vaccine antigens are designed by aligning numerous primary sequences and choosing the most common amino acid or base pair at each site by using high-powered and patented bioinformatics approaches. The SynCon? DNA vaccines in combination with the CELLECTRA? delivery device provide greater levels of cross-reactive immune responses than those produced by more traditional vaccines.
Over the years, VGX Pharmaceuticals has also established itself as a leading manufacturer of cGMP-grade DNA plasmids. Most recently, the Company expanded its cGMP manufacturing facility in The Woodlands, Texas to a 500-liter scale and initiated a project to build and operate a 3000-liter cGMP manufacturing facility in Korea with its affiliate, VGX International.
VGX Pharmaceuticals has already initiated IND-enabling pre-clinical toxicology studies for VGX-3400 and two other DNA plasmid-based product candidates: a vaccine for human papilloma virus for the treatment of cervical cancer (VGX-3100) and a therapeutic based on human growth hormone releasing hormone (VGX-3200) for cancer-related cachexia. The Company expects to complete the toxicology studies and to file the INDs for all three products in 2008.
About VGX Pharmaceuticals
VGX Pharmaceuticals is a biopharmaceutical company with small molecule and biologic product candidates for the treatment of infectious diseases, cancer, and inflammatory diseases. The Company's clinical development programs include PICTOVIR? for HIV infection and VGX-410C for chronic HCV infection, both of which are currently in Phase II clinical trials. In addition, VGX is planning to initiate Phase I clinical studies for VGX-1027, its lead compound for inflammatory diseases. VGX's research pipeline includes a new generation of DNA vaccines and therapeutics as well as CELLECTRA? electroporator, a patented DNA delivery device. The product candidates and technology programs are protected by the Company's extensive global intellectual property portfolio. More information about VGX can be found at www.vgxp.com.
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