EAGAN, MN – December 13, 2005 – Biothera today announced that it has
initiated a Phase I clinical trial with Imprime PGGTM.
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
