Biothera Files IND on Imprime PGG for Combined Therapy with Monoclonal Antibodies for Treatment of Cancer

EAGAN, MN – October 24, 2005 – Biothera, the immune health company, has filed an investigational new drug (IND) application with the U.S. Food and Drug Administration for Imprime PGGÔ for the treatment of cancer in combination with approved monoclonal antibodies, including Genentech’s HerceptinÒ.

Preclinical research indicated that Imprime PGG significantly enhanced the effectiveness of monoclonal antibody therapy to both kill tumors and increase long-term survival rates. Imprime PGG recruits and primes neutrophils, the most abundant type of immune cell in the body, to kill cancer cells targeted by monoclonal antibodies. Neutrophils and other innate immune cells are generally not involved in the fight against cancer because they fail to see cancer as “non-self.”

“The significance of this technology is that it engages a whole new arm of the immune system against cancer,” said Ketan Desai, M.D., Ph.D., chief medical officer of Biothera. “Imprime PGG represents a platform technology that could work with a broad range of monoclonal antibodies.”

Imprime PGG is an intravenous drug candidate derived from the cell walls of a proprietary form of Saccharomyces cerevisiae (Baker’s yeast). There is a growing body of data supporting the ability of yeast beta glucans to benefit immune function and the body’s efforts to protect itself from disease. Biothera’s cancer application is the result of years of research, primarily with the James Graham Brown Cancer Center at the University of Louisville.

“We believe there is tremendous potential for Imprime PGG to improve cancer patient outcomes when administered with complement-activating monoclonal antibodies and vaccines,” said Richard Mueller, Biothera president and chief executive officer.

Daniel Conners, Biothera founder and chairman, said: “There are eight monoclonal antibodies approved for clinical use against cancer and hundreds more in development. Our research indicates that Imprime PGG would be efficacious with the majority of these approved and developmental therapies. This IND filing is the culmination of years of research and millions of dollars of investment. It represents the beginning of an aggressive clinical development program that ultimately will include multiple combinations targeting various cancer types.”

Imprime PGG is protected by more than 40 U.S. patents and several patents pending, as well as additional filings in more than 20 countries.

About Biothera, the Immune Health Company
Biothera is a biotechnology company dedicated to improving immune health. The company's primary focus is developing pharmaceuticals whose unique mechanism of action engages immune cells not normally involved in the fight against cancer. In addition, Biothera’s healthcare group manufactures and markets food-grade immune-enhancing ingredients for the nutritional supplement, functional food, cosmetic and the animal feed and nutrition markets.

David Walsh
VP, Communications
Biothera, the Immune Health Company
[email protected]

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