Biothera To Present Imprime PGG(R) Clinical Trial Results At The International Society For Biological Therapy Of Cancer

Main Category: Cancer / Oncology
Article Date: 31 Oct 2008 - 6:00 PDT

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Biothera will present the results of two separate Phase I clinical trials evaluating the safety of Imprime PGG®, the company's developmental immunotherapy cancer drug, at the International Society for Biological Therapy of Cancer on Saturday, November 1 in San Diego, Calif.

Biothera has completed two randomized, double-blind, placebo-controlled clinical studies in a total of 36 healthy volunteers. In the first Phase I study, subjects received a single intravenous infusion of placebo or Imprime PGG at doses of 0.5, 1.0, 2.0, 4.0 or 6.0 mg/kg. A second Phase I study was conducted in which volunteers received seven consecutive daily intravenous infusions or placebo or Imprime PGG at doses of 1.0, 2.0 or 4.0 mg/kg. Both studies evaluated safety and pharmacokinetic responses. In addition, Biothera completed a Phase I/II study in 67 healthy subjects receiving Imprime PGG and G-CSF or G-CSF alone.

"In multiple clinical trials, Imprime PGG has demonstrated a strong safety profile," said Daniel Conners, Biothera chairman and founder. "In more than 100 healthy subjects, Imprime PGG was safe and well tolerated in a broad range of dose levels."

The International Society for Biological Therapy of Cancer annual meeting facilitates exchange of the most cutting edge preclinical and clinical data on the use of biological therapies in cancer between basic scientists and clinicians from academic, regulatory and industrial venues. This meeting will provide education on the latest advances and allow investigators to share and build on their data, ultimately leading to better patient outcomes in cancer.

Biothera is presently conducting a dual-arm clinical trial in metastatic colorectal cancer (mCRC) patients. Arm one of the trial combines Imprime PGG with Erbitux® (cetuximab) and irinotecan, a chemotherapy drug, which is the standard of care for second- and third-line mCRC patients. Arm two of the trial combines Imprime PGG and Erbitux alone without chemotherapy.

About Imprime PGG®

Imprime PGG is a novel immunotherapy that can enhance the immune response against a number of disease indications. Imprime PGG works in concert with anti-tumor monoclonal antibodies to activate a large population of the body's immune cells (neutrophils) to kill cancer cells. Unlike other drugs that trigger a broad innate immune response, Imprime PGG selectively activates immune cells without inducing pro-inflammatory cytokines, which reduces potential side effects. As a platform therapeutic in oncology, Imprime PGG has the potential to improve patient response rates for existing monoclonal antibody therapies in approved indications, create new indications for these drugs and enhance the efficacy of development-stage monoclonal antibody drugs.

About Biothera, the Immune Health Company

Biothera is a biotechnology company dedicated to improving immune health. The company is developing pharmaceuticals that engage the innate immune system to fight cancer.

Biothera, the Immune Health Company