News | May 9, 2001

Galenica to collaborate with UAB to study enhancement of mucosal immunity

Galenica Pharmaceuticals recently announced that it has entered into an agreement with The University of Alabama at Birmingham (UAB) to evaluate the effects of its proprietary immune enhancer adjuvant GPI-0100 on mucosal immunity. Under the terms of the agreement, Galenica's lead product will be evaluated pre-clinically for its effectiveness in stimulating a protective mucosal immune response against several infectious agents.

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 pathogen-resistant agents have the unique ability to stimulate antigen-specific cytotoxic T lymphocytes (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 being studied in a Phase I human clinical trial for the treatment of prostate cancer under an agreement with Memorial Sloan Kettering Cancer Center. Galenica also has a pipeline of other immune enhancing agents that are in various stages of development.

"The ability of GPI-0100 to enhance mucosal immunity would lead to the use of this compound in vaccines where a mucosal immune response is critical, including respiratory and sexually transmitted diseases," said Dante Marciani, ScD, PhD, Galenica's founder and chief executive officer. "Since our initial findings have shown that GPI-0100 stimulates an effective humoral and T-cell immune response against a variety of antigens, including different infectious agents, we are interested in learning about its effects on mucosal immunity. Therefore, these studies are important to expand the potential applications of GPI-0100 in the prevention of several infectious diseases."

Galenica's immune enhancers have already been shown to stimulate the two components of the body's naturally occurring immune system, humoral (B cell) and cellular (T cell).

The body's mucosal surfaces, including those of the mouth lining, throat, gastrointestinal, urogenital and respiratory tracts, provide entry points for different bacterial and viral pathogenic agents. These pathways can be exploited for new and effective vaccine delivery methods, such as nasal sprays and suppositories. Delivery of vaccines formulated with GPI-0100 via these pathways may stimulate immunity at the mucosal as well as the humoral and cellular levels.

"Most infectious agents cause disease by invading the body's mucosal surfaces," said Dr. Suzanne Michalek, Professor at the UAB Department of Microbiology and scientific director of the studies. "Thus, an effective way to protect against infection would be to stimulate a protective immunity using vaccines capable of stimulating the production of antibodies on mucosal surfaces. As Galenica's GPI-0100 has already been proven to enhance both humoral and cellular immunity, it makes an attractive experimental compound for stimulating mucosal immunity. Positive test results could lead to the development of new vaccines against many infectious diseases, such as genital herpes and AIDS, for which no preventative vaccines are currently available."

About Galenica Pharmaceuticals

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 bioinformatic and proteomic tools for optimal performance. These therapeutic products are expected to enable physicians to modulate patients' immune response against diseases with minimal side effects.

Source: Galenica Pharmaceuticals

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