Eagan, MN – March 28, 2005 – Biothera, the immune health company,
has completed an important pharmaceutical manufacturing milestone
that is part of the process for filing an Investigational New Drug (IND)
application with the FDA for its compound, Imprime™
PGG.
Biothera has completed development of a multimillion-dollar
manufacturing suite in strict compliance with pharmaceutical cGMP
(Good Manufacturing Practice) guidelines in Marlboro, Mass. The
company has produced non-clinical trial material that is being used
in various preclinical studies and a 28-day toxicology study that
will support Biothera’s clinical program for this compound. Biothera
is scheduled to complete the production of clinical trial material
of
Imprime
PGG, a cancer
therapy, under cGMP conditions in May.
“The rapid completion of this new facility demonstrates the superior
ability of our manufacturing processes to produce biologics,” said
Richard Mueller, Biothera president and chief executive officer. “We
are confident that we can reproduce and scale up production of
Imprime PGG under cGMP conditions.”
“At this facility we have validated a new manufacturing process for
our drug compound,” said Daniel Conners, Biothera chairman and
founder. “The new process is more economical and can be reproduced
by a third party licensee.”
In preclinical research, Imprime PGG has worked synergistically with
monoclonal antibodies and cancer vaccines. Imprime PGG has a novel
mechanism of action that engages immune cells to kill tumor cells
they normally fail to recognize as cancer. The discovery of this
entirely new cancer killing mechanism represents a technology
platform with the potential to dramatically increase survival rates
for the vast majority of cancers.
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.
Contact:
David Walsh
VP, Communications
Biothera, the Immune Health Company
651-256-4606
dwalsh@biotherapharma.com
