PowderJect DNA Vaccine First to Achieve Protective Immunity in Non-Responders To Commercial Vaccine

Apr 24, 2001, 01:00 ET from PowderJect Pharmaceutical Plc

    OXFORD, England, FREMONT, Calif., and MADISON, Wis., April 24 /PRNewswire
 Interactive Press Release/ -- PowderJect Pharmaceuticals Plc (London: PJP) and
 its wholly owned subsidiary, PowderJect Vaccines Inc., today announced the
 first achievement of protective immunity by a DNA vaccine in volunteers who do
 not respond to current commercial vaccines. The preliminary data from the
 hepatitis B DNA vaccine clinical study will be presented today at the Fourth
 Annual Conference on Vaccine Research in Arlington, VA by the clinical
 investigator, Dr. Gregory A. Poland of the Mayo Clinic. The study is part of
 PowderJect's major DNA vaccine collaboration with GlaxoSmithKline.
     The phase I study, which is still ongoing and will involve 30 healthy
 volunteers in total, is designed to evaluate the immunogenicity and
 reactogenicity (tolerability) of the novel PowderJect hepatitis B DNA vaccine
 in those who failed to achieve protection from current commercial vaccines
 (non-responders) and those whose protection has waned. The preliminary data
 relate to two groups of non-responders:  those who did not attain protective
 levels of antibodies after one course of vaccination (three doses) and those
 who failed to achieve protection after two or three courses (six to nine
 doses). The 11 volunteers in these two groups have received to date between
 one and three doses of DNA vaccine administered via the needle-free
 PowderJect(R) system, and under the study protocol will all go on to receive
 three doses in total.
     The PowderJect DNA vaccine proved highly immunogenic, inducing protective
 levels of antibodies in 80% (n=5) of volunteers who had not responded to
 three doses of commercial vaccine. The DNA vaccine also elicited protective
 levels in 50% (n=6) of those who were previously non-responsive to as many as
 nine doses of currently licensed vaccine. Importantly, the DNA vaccine
 demonstrated a highly favorable safety and reactogenicity profile.
     "We are very excited by the results we have achieved so far with this
 novel approach to vaccination," commented Dr. Lendon Payne, Vice President of
 Research at PowderJect Vaccines Inc. "To elicit protective levels of
 antibodies in the majority of non-responders with our PowderJect hepatitis B
 DNA vaccine is a great achievement. But of equal importance is the extremely
 low level of reactogenicity we attained, suggesting that this new vaccine is
 very well tolerated."
     "This is yet another 'first' for PowderJect in the field of DNA
 vaccination," said Dr. Paul R. Drayson, Chairman and Chief Executive of
 PowderJect Pharmaceuticals. "In an earlier clinical trial we demonstrated a
 DNA vaccine world first by eliciting protective levels of antibodies in 100%
 of previously unvaccinated volunteers. We have now shown that our PowderJect
 hepatitis B DNA vaccine has the potential to protect many of those who do not
 respond to current commercial vaccines. These encouraging results underline
 our world lead in the field of DNA vaccines and highlight the progress we
 continue to make as we develop these next generation medicines."
 
     Notes for editors:
     Hepatitis B, one of the most common infectious diseases in the world, is a
 potentially fatal liver disease and is the world's ninth biggest killer.
 Globally there are more than 350 million long-term carriers of the virus, of
 which approximately one third are expected to develop serious progressive
 liver disease, leading to liver cirrhosis and cancer. Hepatitis B is
 responsible for the largest vaccines market in the world, with sales of
 preventive products exceeding $1 billion per year. The recommended course of
 three doses of hepatitis B vaccine induces protective antibody responses in
 >90% of healthy adults and in >95% of infants, children and adolescents.
      PowderJect is a rapidly growing pharmaceutical company based in Oxford
 and Speke in the UK, and Fremont, California and Madison, Wisconsin in the
 USA. With a range of products sold under its Evans Vaccines brand, PowderJect
 is the world's 6th largest vaccines company.
     PowderJect's technology focus is on the powder injection of medicines, a
 field in which it leads the world. The company was established in 1993 to
 exploit research at Oxford University into pharmaceutical delivery, and is
 developing a broad range of novel products in-house and for leading
 pharmaceutical companies based upon the use of its proprietary powder
 injection systems.
     The needle-free PowderJect(R) system delivers vaccines, drugs and
 diagnostics painlessly in a dry powder formulation of microscopic solid
 particles. These particles are accelerated to high velocity in a jet of gas
 generated from a helium microcylinder contained inside the easy-to-use,
 hand-held PowderJect device. The powder-form medicine is propelled down a
 specially designed nozzle into the outer layers of the skin. Powder injection
 is a novel technique, unique to PowderJect, and is protected by a broad
 portfolio of 60 patent families. PowderJect is developing products based on
 this proprietary technique in several important fields, including vaccines and
 biopharmaceuticals.
     DNA vaccines are an important part of PowderJect's pipeline and represent
 a revolutionary new method of vaccination. These vaccines include
 non-infectious DNA elements from a virus or other pathogen (disease causing
 micro-organism), and therefore cannot cause disease, yet closely mimic the
 natural process of infection resulting in an immune response. This provides a
 method to stimulate both the antibody and cellular arms of the immune system.
 Activating cellular immune responses is thought to be essential in the
 treatment of diseases such as hepatitis B, HIV and cancer. Therefore this new
 approach offers the potential of new immunotherapeutics to treat some of the
 world's most serious diseases.
     PowderJect has developed a novel approach to DNA vaccination, in which DNA
 from a pathogen is adhered to microscopic gold particles and is delivered
 painlessly into the skin using the needle-free dermal PowderJect(R) system.
 Once inside the epidermal skin cells, the DNA separates from the gold
 particles and directs the cell to manufacture a specific protein, which then
 elicits an immune response.
 
                      MAKE YOUR OPINION COUNT - Click Here
                http://tbutton.prnewswire.com/prn/11690X47122646
 
 

SOURCE PowderJect Pharmaceutical Plc
    OXFORD, England, FREMONT, Calif., and MADISON, Wis., April 24 /PRNewswire
 Interactive Press Release/ -- PowderJect Pharmaceuticals Plc (London: PJP) and
 its wholly owned subsidiary, PowderJect Vaccines Inc., today announced the
 first achievement of protective immunity by a DNA vaccine in volunteers who do
 not respond to current commercial vaccines. The preliminary data from the
 hepatitis B DNA vaccine clinical study will be presented today at the Fourth
 Annual Conference on Vaccine Research in Arlington, VA by the clinical
 investigator, Dr. Gregory A. Poland of the Mayo Clinic. The study is part of
 PowderJect's major DNA vaccine collaboration with GlaxoSmithKline.
     The phase I study, which is still ongoing and will involve 30 healthy
 volunteers in total, is designed to evaluate the immunogenicity and
 reactogenicity (tolerability) of the novel PowderJect hepatitis B DNA vaccine
 in those who failed to achieve protection from current commercial vaccines
 (non-responders) and those whose protection has waned. The preliminary data
 relate to two groups of non-responders:  those who did not attain protective
 levels of antibodies after one course of vaccination (three doses) and those
 who failed to achieve protection after two or three courses (six to nine
 doses). The 11 volunteers in these two groups have received to date between
 one and three doses of DNA vaccine administered via the needle-free
 PowderJect(R) system, and under the study protocol will all go on to receive
 three doses in total.
     The PowderJect DNA vaccine proved highly immunogenic, inducing protective
 levels of antibodies in 80% (n=5) of volunteers who had not responded to
 three doses of commercial vaccine. The DNA vaccine also elicited protective
 levels in 50% (n=6) of those who were previously non-responsive to as many as
 nine doses of currently licensed vaccine. Importantly, the DNA vaccine
 demonstrated a highly favorable safety and reactogenicity profile.
     "We are very excited by the results we have achieved so far with this
 novel approach to vaccination," commented Dr. Lendon Payne, Vice President of
 Research at PowderJect Vaccines Inc. "To elicit protective levels of
 antibodies in the majority of non-responders with our PowderJect hepatitis B
 DNA vaccine is a great achievement. But of equal importance is the extremely
 low level of reactogenicity we attained, suggesting that this new vaccine is
 very well tolerated."
     "This is yet another 'first' for PowderJect in the field of DNA
 vaccination," said Dr. Paul R. Drayson, Chairman and Chief Executive of
 PowderJect Pharmaceuticals. "In an earlier clinical trial we demonstrated a
 DNA vaccine world first by eliciting protective levels of antibodies in 100%
 of previously unvaccinated volunteers. We have now shown that our PowderJect
 hepatitis B DNA vaccine has the potential to protect many of those who do not
 respond to current commercial vaccines. These encouraging results underline
 our world lead in the field of DNA vaccines and highlight the progress we
 continue to make as we develop these next generation medicines."
 
     Notes for editors:
     Hepatitis B, one of the most common infectious diseases in the world, is a
 potentially fatal liver disease and is the world's ninth biggest killer.
 Globally there are more than 350 million long-term carriers of the virus, of
 which approximately one third are expected to develop serious progressive
 liver disease, leading to liver cirrhosis and cancer. Hepatitis B is
 responsible for the largest vaccines market in the world, with sales of
 preventive products exceeding $1 billion per year. The recommended course of
 three doses of hepatitis B vaccine induces protective antibody responses in
 >90% of healthy adults and in >95% of infants, children and adolescents.
      PowderJect is a rapidly growing pharmaceutical company based in Oxford
 and Speke in the UK, and Fremont, California and Madison, Wisconsin in the
 USA. With a range of products sold under its Evans Vaccines brand, PowderJect
 is the world's 6th largest vaccines company.
     PowderJect's technology focus is on the powder injection of medicines, a
 field in which it leads the world. The company was established in 1993 to
 exploit research at Oxford University into pharmaceutical delivery, and is
 developing a broad range of novel products in-house and for leading
 pharmaceutical companies based upon the use of its proprietary powder
 injection systems.
     The needle-free PowderJect(R) system delivers vaccines, drugs and
 diagnostics painlessly in a dry powder formulation of microscopic solid
 particles. These particles are accelerated to high velocity in a jet of gas
 generated from a helium microcylinder contained inside the easy-to-use,
 hand-held PowderJect device. The powder-form medicine is propelled down a
 specially designed nozzle into the outer layers of the skin. Powder injection
 is a novel technique, unique to PowderJect, and is protected by a broad
 portfolio of 60 patent families. PowderJect is developing products based on
 this proprietary technique in several important fields, including vaccines and
 biopharmaceuticals.
     DNA vaccines are an important part of PowderJect's pipeline and represent
 a revolutionary new method of vaccination. These vaccines include
 non-infectious DNA elements from a virus or other pathogen (disease causing
 micro-organism), and therefore cannot cause disease, yet closely mimic the
 natural process of infection resulting in an immune response. This provides a
 method to stimulate both the antibody and cellular arms of the immune system.
 Activating cellular immune responses is thought to be essential in the
 treatment of diseases such as hepatitis B, HIV and cancer. Therefore this new
 approach offers the potential of new immunotherapeutics to treat some of the
 world's most serious diseases.
     PowderJect has developed a novel approach to DNA vaccination, in which DNA
 from a pathogen is adhered to microscopic gold particles and is delivered
 painlessly into the skin using the needle-free dermal PowderJect(R) system.
 Once inside the epidermal skin cells, the DNA separates from the gold
 particles and directs the cell to manufacture a specific protein, which then
 elicits an immune response.
 
                      MAKE YOUR OPINION COUNT - Click Here
                http://tbutton.prnewswire.com/prn/11690X47122646
 
 SOURCE  PowderJect Pharmaceutical Plc