Galenica Pharmaceuticals Announces Research Agreement With the University Of Alabama at Birmingham (UAB) to Evaluate Herpes Simplex Virus Vaccine

Studies Will Evaluate Effectiveness of a Recombinant Sub-unit Vaccine Against

Herpes Virus Using Galenica's Proprietary Immune Enhancer GPI-0100



Apr 10, 2001, 01:00 ET from Galencia Pharmaceuticals

    BIRMINGHAM, Ala., April 10 /PRNewswire/ -- Galenica Pharmaceuticals today
 announced that it has entered into an agreement with UAB to evaluate a
 recombinant sub-unit vaccine against herpes simplex virus (HSV) developed
 using its proprietary immune enhancer (adjuvant) GPI-0100. Under the terms of
 the agreement, Galenica's HSV vaccine candidate will be pre-clinically
 evaluated for its effectiveness in stimulating a protective preventive immune
 response against HSV; the study will also measure the effects on the lesions
 caused by the infection.
     "Our initial findings have shown that GPI-0100 stimulates a protective
 immune response in mice against lethal doses of HSV and no latent infection
 has been detected by PCR," said Dante J. Marciani, Sc.D., Ph.D., Galenica's
 founder and chief executive officer.  "Because of GPI-0100's capacity to
 stimulate a humoral and cell-mediated immunity, its inclusion in vaccines may
 result in a safe and protective immune response against infection, as well as
 a beneficial effect on the lesions caused by HSV infection. We believe that
 our immune stimulant offers a promising approach to developing an effective
 vaccine for the prevention and treatment of herpes infections. We are hopeful
 that any findings from our research collaboration with the UAB scientists will
 support our previous results."
     Dr. Earl Kern, Research Professor at the UAB Pediatric Department and an
 authority on HSV, said:  "The need for an effective HSV vaccine is an
 increasingly important public health concern in view of this virus' continued
 spread during the past twenty years.  We hope this research will bring us
 closer to finding ways to prevent this distressing disease, as well as new
 therapeutic approaches."
     The Center for Disease Control reports that the prevalence of HSV-2 or
 genital herpes in the U.S. is about 45 million. HSV-2 can cause painful
 genital ulcers and severe complications in people with suppressed immune
 systems. HSV-2 infection in pregnant women also creates a high risk of
 transmission to the newborn with potentially fatal consequences. Infection
 with HSV-2 also plays an important role in the heterosexual spread of HIV, by
 making people more susceptible to infection.
     Recent attempts to develop HSV vaccines have resulted in vaccines that
 provide a partial protection against infection only to females, not males. The
 drawbacks of these vaccines may be that they stimulate only an antibody
 response, and fail to stimulate a T-cell or cell-mediated immune response.
 This partial protection of females may be caused in part by the neutralizing
 antibodies present in their body secretions. To protect both female and male
 populations, a T-cell immune response would be essential to destroy cells
 harboring the virus. Thus, an effective HSV vaccine would require immune
 enhancers capable of eliciting both humoral and T-cell immunity in a strong,
 effective and long-term protection.
     The GPI-0100 series is Galenica's lead family of adjuvants comprised of
 second-generation, semi-synthetic derivatives of certain natural saponins.
 These plant-derived saponins have the unique ability to stimulate
 antigen-specific CTL production that will seek and destroy cells carrying
 abnormal markers, such as viral, intracellular parasites or tumor markers. The
 immune enhancer GPI-0100 is currently being studied in a Phase I human
 clinical trial for the treatment of prostate cancer under an agreement with
 Memorial Sloan Kettering Cancer Center.  The company also has a pipeline of
 other immune enhancing agents that are in various stages of development.
     Galenica Pharmaceuticals is a closely held biopharmaceutical company that
 develops novel vaccine products for cancer and infectious disease using its
 proprietary adjuvant and carrier technology combined with the tools of
 proteomics and bioinformatics.  These new therapeutics will enable physicians
 to optimally modulate the immune system against diseases with minimal side
 effects.
 
 

SOURCE Galencia Pharmaceuticals
    BIRMINGHAM, Ala., April 10 /PRNewswire/ -- Galenica Pharmaceuticals today
 announced that it has entered into an agreement with UAB to evaluate a
 recombinant sub-unit vaccine against herpes simplex virus (HSV) developed
 using its proprietary immune enhancer (adjuvant) GPI-0100. Under the terms of
 the agreement, Galenica's HSV vaccine candidate will be pre-clinically
 evaluated for its effectiveness in stimulating a protective preventive immune
 response against HSV; the study will also measure the effects on the lesions
 caused by the infection.
     "Our initial findings have shown that GPI-0100 stimulates a protective
 immune response in mice against lethal doses of HSV and no latent infection
 has been detected by PCR," said Dante J. Marciani, Sc.D., Ph.D., Galenica's
 founder and chief executive officer.  "Because of GPI-0100's capacity to
 stimulate a humoral and cell-mediated immunity, its inclusion in vaccines may
 result in a safe and protective immune response against infection, as well as
 a beneficial effect on the lesions caused by HSV infection. We believe that
 our immune stimulant offers a promising approach to developing an effective
 vaccine for the prevention and treatment of herpes infections. We are hopeful
 that any findings from our research collaboration with the UAB scientists will
 support our previous results."
     Dr. Earl Kern, Research Professor at the UAB Pediatric Department and an
 authority on HSV, said:  "The need for an effective HSV vaccine is an
 increasingly important public health concern in view of this virus' continued
 spread during the past twenty years.  We hope this research will bring us
 closer to finding ways to prevent this distressing disease, as well as new
 therapeutic approaches."
     The Center for Disease Control reports that the prevalence of HSV-2 or
 genital herpes in the U.S. is about 45 million. HSV-2 can cause painful
 genital ulcers and severe complications in people with suppressed immune
 systems. HSV-2 infection in pregnant women also creates a high risk of
 transmission to the newborn with potentially fatal consequences. Infection
 with HSV-2 also plays an important role in the heterosexual spread of HIV, by
 making people more susceptible to infection.
     Recent attempts to develop HSV vaccines have resulted in vaccines that
 provide a partial protection against infection only to females, not males. The
 drawbacks of these vaccines may be that they stimulate only an antibody
 response, and fail to stimulate a T-cell or cell-mediated immune response.
 This partial protection of females may be caused in part by the neutralizing
 antibodies present in their body secretions. To protect both female and male
 populations, a T-cell immune response would be essential to destroy cells
 harboring the virus. Thus, an effective HSV vaccine would require immune
 enhancers capable of eliciting both humoral and T-cell immunity in a strong,
 effective and long-term protection.
     The GPI-0100 series is Galenica's lead family of adjuvants comprised of
 second-generation, semi-synthetic derivatives of certain natural saponins.
 These plant-derived saponins have the unique ability to stimulate
 antigen-specific CTL production that will seek and destroy cells carrying
 abnormal markers, such as viral, intracellular parasites or tumor markers. The
 immune enhancer GPI-0100 is currently being studied in a Phase I human
 clinical trial for the treatment of prostate cancer under an agreement with
 Memorial Sloan Kettering Cancer Center.  The company also has a pipeline of
 other immune enhancing agents that are in various stages of development.
     Galenica Pharmaceuticals is a closely held biopharmaceutical company that
 develops novel vaccine products for cancer and infectious disease using its
 proprietary adjuvant and carrier technology combined with the tools of
 proteomics and bioinformatics.  These new therapeutics will enable physicians
 to optimally modulate the immune system against diseases with minimal side
 effects.
 
 SOURCE  Galencia Pharmaceuticals