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University of Alabama at Birmingham Comprehensive Cancer Center Initiate Phase I Trial of Novel HER-2 Vaccine for Breast Cancer

             Trial will study Galenica's GPI-0100 immune enhancer

    BIRMINGHAM, Ala., Sept. 17 /PRNewswire/ -- Galenica Pharmaceuticals today
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 novel
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.
    Pre-clinical 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 semi-synthetic 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 significant impact on the
efficacy and cost of long-term cancer therapy.  Vaccination using synthetic
antigens would allow a focused immune response against the cancer cells, while
avoiding the complications that may arise from the prolonged use of agents
such as monoclonal antibodies.  These vaccines would offer additional options
for cancer therapy."
    Galenica founder and CEO, Dante J. Marciani, Sc.D., Ph.D. commented, "We
are pleased to be collaborating with the well known UAB-CCC, in the
development of such an important vaccine.  Our pre-clinical findings have
shown that GPI-0100 stimulates both humoral and T-cell immune response with
production of cytotoxic T cells, and ongoing clinical studies are confirming
its safety.  Because of these properties, its inclusion in cancer vaccines
containing suitable antigens may stimulate an effective anti-tumor immune
response.  We believe that our proprietary immune enhancer technology offers
promise for developing vaccines for the treatment of different cancers, for
which no other effective therapies may be available."
    HER-2 is overexpressed in about 20 to 30% of cancers of the breast, ovary,
lung, and stomach and is usually associated with a poor clinical outcome.
Clinical studies in patients with breast cancer have shown that the HER-2
receptor is a good target for cancer immune therapy.
    Galenica Pharmaceuticals Inc. is a closely held company engaged in the
development of novel products for the prevention and active immunotherapy of
cancer and infectious diseases.  The company's proprietary vaccine
formulations integrate its immune enhancers and carriers with antigens
designed using proteomic tools for optimal performance.  These therapeutic
products are expected to enable physicians to modulate patients' immune
response against diseases with minimal side effects.  Press releases and other
corporate information can be found on Galenica's website at
http://www.galenicapharma.com .

    CONTACT:  David Vigor, Executive Vice President of Galenica
              Pharmaceuticals, +1-205-982-8676, or dvigor@galenicapharma.com

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