University of Alabama to initiate phase I trial of HER-2 vaccine.

2002 DEC 18 - (NewsRx.com & NewsRx.net) -- Galenica Pharmaceuticals announced that the University of Alabama at Birmingham Comprehensive Cancer Center (UAB-CCC) is beginning a National Cancer Institute-sponsored phase I human clinical trial of a HER-2 vaccine containing Galenica's immune enhancer GPI-0100.

The trial will evaluate a therapeutic vaccine containing a HER-2 derived antigen designed by UAB and Ohio State University scientists together with Galenica's proprietary immune enhancer GPI-0100 to treat patients with HER-2 overexpressing cancers.

Preclinical studies showed that vaccination with this antigen, a synthetic peptide containing regions of the HER-2 receptor and the measles virus fusion protein, is highly effective in preventing breast cancer in transgenic mice overproducing HER-2. Vaccination with this peptide stimulated not only blocking antibodies against HER-2, but also antibody mediated killing (ADCC) of tumor cells overexpressing the HER-2 receptor.

An immune enhancer or adjuvant is a critical vaccine component that is required to stimulate a protective and/or therapeutically effective immune response against cancer cells or infectious agents. Galenica's lead adjuvant, GPI-0100, is a semisynthetic derivative from certain natural saponins which have the capability of stimulating a Th1 immunity with production of antibodies capable of mediating ADCC and of antigen-specific cytotoxic T-cells (CTL) that will seek out and destroy cells carrying abnormal markers, such as viral or tumor antigens.

Dr. Pierre Triozzi, associate professor of medicine at the UAB-CCC and principal investigator for the clinical trials, said: "The development of effective and safe cancer vaccines would have a ...