Saponins and Phytosterols Triterpenoid saponins (see below) Aescin Avenacin A-1 Glycyrrhetinic acid Glycyrrhizin Saikosaponin A Senegin II Ursolic acid Steroid saponins Astragaloside III Cimicifugoside Diosgenin; Nitogenin Ginsenoside Re Ginsenoside Rf Ginsenoside Rg Ruscogenin Saponins work as antioxidants by inhibiting the formation of free radicals. Saponins inhibit the human-immunodeficiency virus (HIV). Saponins bind Cholesterol Saponins bind cholesterol in the gut. This includes both dietary cholesterol and cholesterol discharged by the liver in waste bile. By being bound, cholesterol  is carried on for elimination with bowel movements rather than being resorbed by the body. The Maasai Paradox Scientists were once perplexed by the diet of the Maasai tribe in African. Maasai obtain 66 percent of calories from fat yet they do not suffer from hypercholesterolemia, atherosclerosis, gallbladder disease, or coronary heart disease. The paradox is that in western cultures high-fat diets have been positively correlated to these diseases. Typically, the high-fat Maasai foods are prepared as soups and routinely have 25 different herbs, usually roots and bark, added. Some of these herbs contain high levels of saponins which bind cholesterol.   Triterpenoid saponins Triterpenoid saponins are naturally occurring sugar conjugates of triterpenes possessing various biological activities, including antiviral action. Two substances isolated from natural sources were tested against herpes simplex virus type 1 replication. They did not show evidence of cytotoxicity under antiviral test conditions. The triterpenoid saponin, isolated from a Brazilian plant (s21), represents the oleanane group and inhibited herpes simplex virus type 1 DNA synthesis. The triterpenoid saponin, isolated from a Chinese plant (s17), represents the ursane group and seemed to inhibit viral capsid protein synthesis of herpes simplex virus type 1. Phytother Res 1999 Jun;13(4):323-8 Mechanism of antiviral activity of triterpenoid saponins. Simoes CM, Amoros M, Girre L Department of Pharmaceutical Sciences, Universidade Federal de Santa Catarina, Florianopolis, Brazil.      Copyright © 2003 Natural Health Resource Project Page last modified: April 07, 2003

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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 -

BIRMINGHAM, Ala - April 10, 2001 - 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.

About Galenica Pharmaceuticals

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.