Biothera Begins Phase I Clinical Trial for Cancer Therapy


EAGAN, MN – December 13, 2005 – Biothera today announced that it has initiated a Phase I clinical trial with Imprime PGG
TM. The company recently received approval from the U.S. Food and Drug Administration for its Investigational New Drug application for Imprime PGG as a combination therapy with cancer monoclonal antibodies.

“Imprime PGG has a novel mechanism of action that in preclinical studies demonstrated an ability to engage another arm of the immune system to fight cancer,” said Daniel Conners, Biothera chairman. “It has the potential to improve therapeutic outcomes for patients with a wide range of cancers and hematopoietic challenges.”

Biothera plans to initiate several Phase II clinical trials next year involving Imprime PGG. “The Phase II trials represent an acceleration of our original development plans,” said Richard Mueller, Biothera president and chief executive officer. “We expect to gain a tremendous amount of clinical data over the next year to 18 months.”

Preclinical research indicates that Imprime PGG significantly enhances the effectiveness of a wide range of monoclonal antibodies, including those on the market as well as many in development. As an innate immune modulator, Imprime PGG also has demonstrated preclinical activity when used in combination with marketed growth factors for both stem cell mobilization and white blood cell recovery.

About Biothera, the Immune Health Company
Biothera is a biotechnology company dedicated to improving immune health. The company's primary focus is developing pharmaceuticals that engage the immune system to protect the body from disease. 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.

Contact:
David Walsh
VP, Communications
Biothera, the Immune Health Company
651-256-4606
dwalsh@biotherapharma.com

 


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