martes, 4 de octubre de 2011

Biothera Completes Second Phase I Clinical Trial For Cancer Drug

Biothera, the immune health company, announced today that it has successfully completed its second Phase I clinical trial for Imprime PGG(TM), 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 daily for seven continuous 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. Website: biotherapharma.



Biothera

biotherapharma

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