EAGAN, Minn., Sept. 25 /PRNewswire/ -- 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: http://www.biotherapharma.com .
Biothera
CONTACT: David Walsh, VP, Communications, of Biothera, the Immune HealthCompany, +1-651-256-4606, dwalsh@biotherapharma.com
