Biothera Completes Second Phase I Clinical Trial for Cancer Drug
EAGAN, MN
–
September 25, 2006
– Biothera,
the immune health company,
announced today that it has successfully completed its second Phase I
clinical trial for Imprime PGG™, its lead compound for activating the body's
own immune system to fight multiple types of cancer.
The randomized, double-blind, placebo-controlled clinical study in healthy
volunteers indicates that Imprime PGG is safe and well tolerated over a wide
dose range. The results of the study support the continued development of
the drug candidate in multiple indications.
The dose-escalation study evaluated safety, pharmacokinetic and
pharmacodynamic responses at three dose levels (1, 2 and 4 mg/kg)
administered intravenously for seven consecutive days. This study
followed a previous Phase I study in which Imprime PGG administered in
single doses was also shown to be safe and well tolerated in healthy
volunteers. A total of 36 volunteers participated in the two Phase I
studies.
"The consistent results of these studies confirm our expectations and
demonstrate that Imprime PGG has a strong safety profile," said Myra
Patchen, Ph.D., Biothera executive vice president of pharmaceutical
development. "We are looking forward to now quickly implementing our Phase
II clinical program in cancer patients."
Biothera's Phase II clinical trial program is scheduled to begin in the
fourth quarter of 2006.
"We are encouraged by these clinical findings and confident in the ability
of Imprime PGG to work synergistically with monoclonal antibodies to treat
numerous types of cancer," said Daniel Conners, Biothera founder and
chairman.
Preclinical research demonstrated that the combination of Imprime PGG and
various anti-cancer monoclonal antibodies significantly improved on the
effectiveness of antibodies alone as evidenced by reductions in tumor size
and increases in survival in multiple types of cancer, including breast,
lung and liver cancer.
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 fight cancer. Pharmaceuticals are also in development to
facilitate immune system recovery after damage from chemotherapy or acute
radiation exposure. In addition, Biothera manufactures and markets
food-grade ingredients that support healthy immune function to the
nutritional supplement, functional food, cosmetic and animal nutrition
markets.
Contact:
David Walsh
VP, Communications
Biothera, the Immune Health Company
651-256-4606
dwalsh@biotherapharma.com
announced today that it has successfully completed its second Phase I
clinical trial for Imprime PGG™, its lead compound for activating the body's
own immune system to fight multiple types of cancer.
The randomized, double-blind, placebo-controlled clinical study in healthy
volunteers indicates that Imprime PGG is safe and well tolerated over a wide
dose range. The results of the study support the continued development of
the drug candidate in multiple indications.
The dose-escalation study evaluated safety, pharmacokinetic and
pharmacodynamic responses at three dose levels (1, 2 and 4 mg/kg)
administered intravenously for seven consecutive days. This study
followed a previous Phase I study in which Imprime PGG administered in
single doses was also shown to be safe and well tolerated in healthy
volunteers. A total of 36 volunteers participated in the two Phase I
studies.
"The consistent results of these studies confirm our expectations and
demonstrate that Imprime PGG has a strong safety profile," said Myra
Patchen, Ph.D., Biothera executive vice president of pharmaceutical
development. "We are looking forward to now quickly implementing our Phase
II clinical program in cancer patients."
Biothera's Phase II clinical trial program is scheduled to begin in the
fourth quarter of 2006.
"We are encouraged by these clinical findings and confident in the ability
of Imprime PGG to work synergistically with monoclonal antibodies to treat
numerous types of cancer," said Daniel Conners, Biothera founder and
chairman.
Preclinical research demonstrated that the combination of Imprime PGG and
various anti-cancer monoclonal antibodies significantly improved on the
effectiveness of antibodies alone as evidenced by reductions in tumor size
and increases in survival in multiple types of cancer, including breast,
lung and liver cancer.
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 fight cancer. Pharmaceuticals are also in development to
facilitate immune system recovery after damage from chemotherapy or acute
radiation exposure. In addition, Biothera manufactures and markets
food-grade ingredients that support healthy immune function to the
nutritional supplement, functional food, cosmetic and animal nutrition
markets.
Contact:
David Walsh
VP, Communications
Biothera, the Immune Health Company
651-256-4606
dwalsh@biotherapharma.com